Abstract of thesis entitled

“An evidence-based pelvic floor muscle training program to reduce urinary

incontinence for patients undergoing transurethral resection of prostate”

Submitted by

Leung Pui Ngan Connie

for the degree of Master of Nursing

at The University of Hong Kong

in July 2014

Transurethral resection of prostate is a golden standard treatment for benign

prostate hypertrophy. However, urinary incontinence is a common phenomenon

of patients after operation. It gives great impact to their quality of life. With the

development evidence-based practice in nursing, nurse translates the best

evidence into practice to reduce urinary incontinence for patients undergoing

transurethral resection of prostate.

Pelvic floor muscle training is a safe and a conservation treatment to reduce

urinary incontinence for patients undergoing operation. It reduces the social and

health burden as well as to promote the development of professional nursing care

in Hong Kong.

This thesis is to develop an evidence-based guideline for patients to practice

pelvic floor muscle training to reduce urinary incontinence undergoing the

transurethral resection of prostate. Systematic literature search were performed

to extract valid articles, finally six articles were selected. Scottish Intercollegiate

Guidelines Network (SIGN) checklist was applied to assess quality of each

study.

The target audiences of the pelvic floor muscle training program are

patients planned to have elective transurethral resection of prostate at least two

weeks before operation. It is proposed to implement in a day and a urology wards

of an acute hospital.

The high implementation potential of the program is estimated after

examination of the local transferability, feasibility and cost-benefit ratio. An

evidence-based practice guideline is developed to deliver the best quality of

nursing care to patients undergoing transurethral resection of prostate. To

facilitate implementation of the program, a tailor-made pilot study with

implementation and evaluation plans are elaborated.

An evidence-based pelvic floor muscle training program to reduce urinary

incontinence for patients undergoing transurethral resection of prostate

by

Leung Pui Ngan Connie

RN, RNM, BSc (Nursing), MSc (AIM)

A thesis submitted in partial fulfillment of the requirements for

the Degree of Master of Nursing

at The University of Hong Kong

July 2014

i

Declaration

I declare that this thesis represent my own work, except where due

acknowledgement is made, and that is has not been previously included in a

thesis, dissertation or report submitted to this University or to any other

institution for a degree, diploma or other qualification.

Signed …………………………………………………………………….

Leung Pui Ngan Connie

ii

Acknowledgements

I would like to thank my supervision, Dr. Denise Chow, who gave me

guidance and support in this thesis. Her generous assistance enabled me to

complete the thesis.

Also, I would like to express my gratefulness to my classmates, who

support and encourage me to get through the difficult times throughout my

period of study.

Finally, I want to express my warmest gratitude to my husband and family

for their patience and support throughout these two years.

iii

Contents

Declaration ............................................................................................................ i

Acknowledgements ............................................................................................... ii

Contents .............................................................................................................. iii

Chapter 1

Introduction ......................................................................................................... 1

1.1 Background ..................................................................................................... 2

1.2 Affirming the Need ......................................................................................... 4

1.3 Research Question .......................................................................................... 6

1.4 Aims and Objectives ....................................................................................... 6

1.5 Significance of the Study ................................................................................ 7

Chapter 2

Critical Appraisal ................................................................................................ 9

2.1 Search Strategy ............................................................................................... 9

2.2 Appraisal Strategies ...................................................................................... 12

2.3 Results……………….. ................................................................................. 13

Chapter 3

Translation and Application ............................................................................. 31

3.1 Implementation Potential .............................................................................. 31

3.2 Transferability of the Findings ...................................................................... 33

3.3 Feasibility… ...................................................... ……………………………35

3.4 Cost-benefit Ratio of the innovation ............................................................. 37

3.5 Evidence-Based Practice Guideline .............................................................. 42

Chapter 4

Implementation Plan ........................................................................................ 51

4.1 Communication Plan ..................................................................................... 51

4.2 Pilot Study Plan ............................................................................................. 57

iv

4.3 Evaluation Plan ............................................................................................. 59

Chapter 5

Conclusion ......................................................................................................... 68

List of Appendices ............................................................................................. 70

Appendix 1: Search Strategies and Result .......................................................... 70

Appendix 2: Table of the Scottish Intercollegiate Guidelines Network (SIGN)

Grading System ............................................................................. 71

Appendix 3: Tables of Evidence ......................................................................... 72

Appendix 4: Methodology Checklists ................................................................ 81

Appendix 5: Summary of Levels of Evidence .................................................... 93

Appendix 6: Summary of Quality Assessment of the Selected Studies .............. 94

Appendix 7: Summary of the Data of the Selected Intervention Studies ........... 95

Appendix 8: Recommendation from Synthesis Process ..................................... 96

Appendix 9: Summary of Recommendation from Reviewed Studies ................ 99

Appendix 10: ICIQ-UI Short Form ................................................................... 101

Appendix 11: The Chinese Version of the ICIQ-UI Short Form ...................... 102

Appendix 12: Nurses’ Evaluation Form for Self-perceived Skills and

Knowledge and Satisfaction Level ............................................. 103

Appendix 13: A Permission Letter for the use of ICIQ-UI Short Form ............ 104

References ........................................................................................................ 105

1

Chapter 1

Introduction

Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the

prostate gland, commonly found in men over the age of 50 (Roehrborn &

McConnell, 2002). Currently, transurethral resection of prostate (TURP) is the

most common and a golden standard treatment for BPH (Paolone, 2010;

Rassweiler, et al., 2006; Sun, 2005). However, 0.6 - 40% of the patients suffered

from urinary incontinence after TURP (Lourenco et al., 2008; Rassweiler et al.,

2006). Urinary incontinence may have great impact on their quality of life and

imposed burden to the health care system. Pelvic floor muscle training (PFMT)

is a safe, feasible and conservation management for urinary incontinence after

TURP. With the professional nursing care, the social and health burden will be

greatly reduced. Although there are a lot of empirical evidences and clinical

practices supporting the PFMT in patients after prostactectomy (Bauer et al.,

2009), a guideline or protocol of PFMT for patients undergoing TURP in local

clinical setting is lacking. The purpose of this translational research is to translate

the best evidence into practice to prevent or reduce the urinary incontinence of

patients underwent TRUP by PFMT.

2

1.1 Background

Benign prostatic hypertrophy (BPH) is a non-malignant enlargement of the

prostate gland, one of the most commonly disease in men over the age of 50.

Prostate becomes larger in most men as they get older. Based on the several

autopsy studies, about 50 - 60% of men in their 60s, and 80 - 90% of men in their

70s and 80s with enlarged prostate (Roehrborn & McConnell, 2002).

In the 2011 Population Census, the life expectancy for men in Hong Kong

was 80 years. Of the 7.07 million populations in Hong Kong, 13.3% (438,257) of

men were 65 years old or above (Census and Statistics Department, 2012). In a

local community survey amongst men in age 40 - 79 in 2003, 16% of Hong Kong

men had moderate to severe lower urinary tract symptoms (Ngai, 2004).

Nowadays, there are different options to treat BPH such as conservative

methods, drug treatment. For moderate to severe lower urinary tract symptoms

secondary to benign prostate hyperplasia, surgical treatment must be considered

if the medical therapy is fail to response. In surgical treatment, TURP is a golden

standard for BPH givens its long-term efficacy established in clinical studies

3

(Paolone, 2010; Rassweiler et al., 2006; Sun, 2005). After successful surgery,

0.6% to 40% of patients may suffer from temporary urinary incontinence in early

post-operatively period (Lourenco et al., 2008; Rassweiler et al., 2006).

The International Continence Society defines urinary incontinence is a

storage symptom with the complaint of involuntary loss of urine (Abrams et al.,

2009). Urinary incontinence is a distressing condition that may have great

impact on patient’s quality of life. It associated with low self-esteem, social

anxiety and depression if persistent incontinence cannot be managed. An

unexpected increased societal cost in seeking health care services and increased

need for nursing home care will be anticipated (Glazener et al., 2011a).

Pelvic floor muscle training (PFMT) is a first-line conservative

management method for urinary incontinence (Harris, 1997). It is a safe,

non-invasive behavioural treatment. It is performed by repeated contraction and

relaxing the pubococcygnus muscles of the pelvic floor to increase its

contractility of the distal urethral sphincter. PFMT is a recommended first-line

treatment for early incontinence that follows prostatectomy within the first 6-12

months (Bauer et al., 2009).

4

1.2 Affirming the Need

In view of the ageing population and increasing life expectancy men in

Hong Kong, urinary incontinence related to the post TURP will be increasing in

future. Currently, TURP is a standard golden operation for BPH; 2365 TURP

were done in Hospital Authority hospitals in Hong Kong in the year of 2010

(Man, 2011). Since the urinary incontinence is usually temporary and it is not a

life-threatening issue after TURP, the prevalence is not well reported in clinical

practice. Also, the outcomes of medical and surgical treatments are usually

evaluated in long-term observation (Willener, Spichiger & Hantikainen, 2008).

I am currently working in a urology ward of a public hospital in Hong Kong.

TURP is the most common operation in a urology ward. By the retrospective

clinical observation from September 2012 to August 2013, there were 15 patients

underwent TURP per month. According to the above studies, 0.6% to 40% of

patients with urinary incontinence after TURP, then 0.1 to 6 patients per month

will suffer from it. Also, nurses received telephone enquiry of average 4 patients

per month about various degree of urinary incontinence after TURP by

retrospective clinical record from July to August 2013. This prevalence presents

5

a substantial health concern in my working area.

A preliminary search of the available evidences on management measures

for urinary incontinence after TURP was carried out. The measures include

supervised PFMT, drug therapy and surgical intervention (Heath & Watson,

2002; Miller & Miller, 2011; Thuroff et al., 2011). In clinical practice, we can

provide PFMT before operation and remind patients to do it after discharge to

help them to regain continence earlier.

Nowadays, there is still lacking of standardization of the most effective

PFMT protocol. There are conflicting evidences in using biofeedback or

electrical stimulation together with PFMT. Also, the identification of the

initiation time for PFMT either before or after operation is needed. The content,

frequency and duration of the PFMT is also being identified. There is a strong

need to conduct an extensive review of well-designed studies to evaluate the

different types of interventions and to develop an evidence-based PFMT

program for patients after TURP in local clinical setting.

Urinary incontinence may have great impact on quality of life of patients. It

6

must be anticipated earlier to prevent any social isolation or depression of

patients. Nurses must play a vital role to promote earlier recovery of patients by

attending physical, psycho-social needs of patients. It will greatly reduce the

health care and social burden.

1.3 Research Question

From the above discussion of the background and the need of the

evidence-based practice on this topic, the research question of this study is “In

patients underwent transurethral resection of prostate, how does the pelvic floor

muscle training compare to without training affect the post-operative urinary

incontinence?”

1.4 Aims and Objectives

The aim of this study is to develop an evidence-based pelvic floor muscle

training program to reduce urinary incontinence for patients undergoing

transurethral resection of prostate.

The objectives of this study are:

(1) To review the current literatures systematically for the effectiveness of the

PFMT for urinary incontinence after TURP;

7

(2) To extract data from the selected studies and compile it into the table of

evidence;

(3) To perform quality assessment of the selected studies;

(4) To identify the best evidence, feasibility and transferability of the PFMT to

the target patients in local setting.

(5) To develop an evidence-based practice protocol for quality care of patients

undergoing TURP in reducing severity and duration of the urinary

incontinence.

1.5 Significance of the Study

Urinary incontinence is a distress commonly after TURP. It threatens

patients’ quality of life and result of social anxiety and isolation. It is worthy to

build an evidence-based pelvic floor muscle training protocol which will benefit

to the patients, health care professionals and the hospital.

For patient, by practicing the PFMT, they can regain urinary continence

earlier and improve quality of life without taking any medication and operation.

It greatly improves their physical and psycho-social well beings. Also, it can

reduce their expenses and trouble in using incontinence pads.

8

For nurses, provide an evidence-based pelvic floor muscle exercises

program to patient undergoing TURP is a health care concern. Through the

program development and implementation, nurses can gain more autonomy and

confidence in nurse led education program as well as the evidence-based

protocol. PFMT is a non-invasive nursing intervention; it is the best opportunity

for nurses to develop their role in their profession.

For health care organization, health care professionals provide safe

evidence-based practice can build her reputation and reduce the financial burden

as well as the social burden to handle the complaints of urinary incontinence

from patients.

9

Chapter 2

Critical Appraisal

After formulated the research question, aims and objectives of the study;

and affirming the need and significance of developing an evidence-based pelvic

floor muscle training program in the local clinical setting, this chapter is going to

discuss the searching and appraisal strategies to identify the best evidence to

support the development of the new guideline.

2.1 Search Strategy

2.1.1 Selection criteria

Inclusion criteria

For the participants, men with BPH, who have undergone a TURP and have

PFMT intervention by health care professionals. The PFMT with and without

biofeedback, electrotherapy, and behavioural therapy are included. They must be

cognitive intact and able to understand the instructions. There is no limitation in

age, continence status and dependence on activity level.

For the types of studies, this review considered randomized controlled trials

(RCT) those report the incidence of doing PFMT before and after TURP. For the

10

outcome measures, the primary outcomes are the incidence of urinary

incontinence and urinary symptoms; the secondary outcomes are the quality of

life and the strength of pelvic floor muscle.

Exclusion criteria

Men were planned or receiving bradytherapy, with urethral or pelvic

surgery, suffering from neurological diseases or cognitive impairment.

2.1.2 Keywords

The keywords for searching were “prostate”, “urinary incontinence”,

“pelvic floor”, “transurethral resection of prostate”, “benign prostate hyperplasia”

and “pelvic floor muscle exercise”.

2.1.3 Search methodology

A search of literature was conducted on 18 August 2013, a systematic

four-step searching were utilized in this study. An initial search from the above

keywords via CINAHL Plus, PubMed, Science Direct and British Nursing Index

databases was done. Keywords and various combinations of them were used. All

the searches were limited the inclusion and exclusion criteria; and published on

11

or after January 1993. There was no language limitation. From the CINAHL Plus

database, only one study was yielded. In PubMed database, 17 studies were

yielded. In Science Direct, 112 studies were yielded. In British Nursing Index, 8

studies were yielded.

A second search, analysis of content in the title and abstract against

inclusive and exclusive criteria were done. One study from the CINAHL Plus, 6

out of 17 studies from PubMed, 2 out of 112 studies from Science Direct and 2

out of 8 studies from British Nursing Index were selected. After reading the

content of the studies, two studies were duplicated (Glazener, et al., 2011a &

2011b) and one study was eliminated due to it only involved one subject

underwent TURP (Joseph, 2000). Then, 6 randomized controlled trials were

selected from these databases searching.

Thirdly, clinical guideline searching was performed in the Scottish

Intercollegiate Guideline Network (SIGN), National Guideline Clearinghouse

(NGC), and American Urological Association (AUA) Guidelines, National

Institute for Clinical Excellence (NICE) and European Association of Urology

(EAU) guideline. However, neither was specific in management of the urinary

12

incontinence after TURP. Fourthly, the reference list of all related articles were

screened with no more additional article was found.

Finally, six randomized controlled trials (RCT) in English were selected in

this review. The table of search strategy and result in these databases was shown

in Appendix 1.

2.2 Appraisal Strategies

Data of the above selected six studies were extracted and recorded in form

of a table of evidence. An evidence table for intervention studies by the Scottish

Intercollegiate Guidelines Network (SIGN) was used. It included data on

bibliographic citation, study design and level of evidence, subject characteristics,

number of participants, dropout rate, intervention, comparison, data collection

time, outcome measures and effect size. Level of evidence of each study was

graded according to the SIGN (2013a) grading system which was shown in

Appendix 2.

For quality assessment of the selected six studies, a methodology checklist

for randomized controlled trials of SIGN (2013b) was used to guide the

13

assessment. The tables of evidence and methodology checklists of six studies

were shown in Appendix 3 and 4 respectively.

2.3 Results

After a systematic four-step searching of literature conducted on 18 August

2013, six studies were selected. Five studies were RCTs (Glazener et al., 2011a;

Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007) and one was

controlled trial (Chang et al. 1998). All were in English and published between

1998 and 2013. Data of all studies were extracted and illustrated in the form of

table of evidence according to the SIGN 50: a guideline developer’s handbook

(SIGN, 2013a). The table of evidence of each intervention study was showed in

Appendix 3.

2.3.1 Summary of levels of evidence

The levels of evidence of the six selected studies ranged from 1++ to 2++.

For the five randomized controlled trials, the level of evidence of Glazener et al.

(2011a) was 1++, Porru et al. (2001) and Tibaek et al. (2007) were 1+, Hou et al.

(2013) and Ip (2004) were 1-. For the controlled trial, the level of evidence was

2++ (Chang et al., 1998). Summary of levels of evidence of selected studies was

14

shown in Appendix 5.

2.3.2 Summary of quality assessment

The critical appraisal checklist of Scottish Intercollegiate Guidelines

Network (SIGN, 2013b) - “methodology checklist 2: controlled trials” was used

to assess quality of the six selected studies (Chang et al., 1998; Glazener et al.,

2011a; Hou et al., 2013; Ip, 2004; Porru et al., 2001; Tibaek et al., 2007).

Individual checklist for each study was shown in Appendix 4. Finally, a table of

the summary of quality assessment of the selected studies was shown in

Appendix 6.

All selected six studies addressed clearly and appropriately on focused

research question and provided details of the intervention and comparison

groups, and the measured outcomes for their research objectives.

Five selected trials were randomized controlled trails. Only two trials

included an adequate method of random group allocation and described

allocation concealment. Remote computer randomization and allocation was

described in Glazener et al. (2011a). Randomization by grouping in blocks of ten

15

of a mathematical table, and sealed in envelops by independent third party was

mentioned in Tibaek et al. (2007). Chang et al. (1998) allocated the groups by

preceding and subsequent men without randomization, this study should be a

controlled trial.

Most of the trials were not describe blinding. Due to the nature of the

intervention, blinding of the therapists, assessors and patients were not possible,

the risk of bias was not counted. However, three trials had made effort to

minimize bias by getting data entry. In Glazener et al., (2011a), data was entered

by clerks blinded to group. In Tibaek et al. (2007) and Porru et al. (2001), an

independent physiotherapist or urologist did initial and outcome pelvic floor

assessment respectively.

There were no significant between groups difference in baseline in all trials

except the one trial (Ip, 2004). It did not mention any demographic data of

subjects in both groups; it mentioned the incontinence state and score only.

For the equality of treatment and control groups being investigated, all

groups were investigated equally in all studies. For the outcome measures, all

16

relevant outcomes were measured in a standard and reliable way in all selected

studies except the one study (Ip, 2004). Her outcomes were not presented in a

statistically measures.

All studies reported the acceptable dropout rate; they ranged from 0% to

15.52%. All of them gave explanation or reasons of any withdrawals or dropouts.

Intention to treat analysis was applied in all studies except two studies with zero

dropout rates (Chang et al., 1998; Ip, 2004).

All studies were carried in one site only except a study by Glazener et al.

(2011a). Subjects were recruited from 34 UK centers, confidence of the result

was increased and comparable for all sites.

The overall methodological quality of the studies to minimize bias ranged

from low quality to high quality. Two studies (Glazener et al., 2011a and Tibaek

et al. 2007) were high quality with little or no risk of bias. Three studies (Chang

et al., 1998; Hou et al. 2013 and Porru et al. 2001) were acceptable quality with

associated risk of bias in missed criteria. One study (Ip, 2004) was low quality. It

might be the study was terminated prematurely due to change of clinical

17

operation.

2.3.3 Summary and synthesis of data

(1) Study characteristics

For the locations of the studies, two were conducted in Taiwan (Chang et al.,

1998; Hou et al., 2013). Other studies were conducted in different countries,

United Kingdom (Glazener et al., 2011a), Australia (Ip, 2004), Italy (Porru et al.,

2001) and Denmark (Tibaek et al., 2007).

For the sample size of the intervention studies, four medium trials of

subjects ranged from 50-66 (Chang et al., 1998; Hou et al., 2013; Porru et al.,

2001; Tibaek et al., 2007); one large trial of 442 subjects in 34 UK centers

(Glazener et al., 2011a) and one small trial of 16 subjects (Ip, 2004). Total 640

subjects participated in these studies.

For the subject characteristics, all trials included patients underwent TURP

who aged between 45 and 79 and did not undergo bradytherapy. In Glazener et al.

(2011a), it consisted of two studies, one was men with radical prostatectomy, and

another was men with transurethral resection of prostate. In this thesis, the study

18

of TURP in Glazener et al. (2011a) was considered. Five studies included men

without urinary catheter after operation (Chang et al., 1998; Glazener et al., 2011;

Hou et al., 2013; Porru et al., 2001; Tibaek et al., 2007) while one included men

with urinary catheter after operation (Ip, 2004).

For study purpose, all studies investigated the effectiveness of the PFMT

intervention. In addition of it, one study compared the effectiveness of

intervention between a visual reminder, refrigerator magnet, and a paper

reminder in PFMT (Ip, 2004); another one study investigated the use of Short

Form-36 Health Survey scale (SF-36) to assess the effect of PFMT (Hou et al.

2013); one study investigated the cost-effectiveness of one to one intensive

PFMT as well (Glazener et al., 2011a).

For comparison, four studies continued usual activity without any PFMT

was taught in control groups (Chang et al., 1998; Glazener et al., 2011a; Hou et

al., 2013; Porru et al., 2001); one study provided information and verbal

instruction of PFMT only after operation , without any individual or group

teaching of PFMT program in control group (Tibaek et al., 2007). A study

provided same PFMT information to both intervention and control groups, but in

19

different form with the magnet and paper reminder to the respective groups (Ip,

2004).

For the dropout rates of the selected trials ranged from 0% to 15.52%. Four

studies dropout rates were below 10% (Chang et al., 1998; Hou et al., 2013; Ip,

2004; Porru et al., 2001) whereas two studies were 10% to 15.52% (Glazener et

al., 2011a; Tibaek et al., 2007).

(2) Assessment and outcome measures

In the assessment and outcome measures, there was a lack of consistency in

the selected studies. A summary of the results was shown in Appendix 7. For the

primary outcomes, they included the urinary incontinence status and lower

urinary tract symptoms. Two trials with evidence levels 1+ and 2++ for men

post-TURP showed significant improvement in urinary incontinence after 4

weeks of PFMT (Chang et al., 1998; Porru et al., 2001). Only one trial with

evidence level 2++ (Chang et. al., 1998) for terminal dribbling, it was

significant improved after PFMT for 4 weeks. Three trials with evidence levels

ranged from 1+ to 2++ showed significant improvements in urinary symptoms

in objective uroflowmetry parameter - maximum urinary flow rate (Q max), and

20

total and storage score of International Prostate Symptom Score (IPSS), and

improvement of voiding interval in voiding diaries recording (Chang et al.,

1998; Hou et al., 2013; Porru et al., 2001).

In Ip (2004), no significant different in incident of urinary incontinence

might be due to small subject size and premature call off of study because of

operation changes. In Glazener et al. (2011a), evidence level 1++, the

International Consultation on Incontinence Questionnaire Urinary Incontinence,

short form (ICIQ-UI SF) was used for screening of the urinary incontinence

status of patients. It showed no significant different because the subjects were

recruited after six weeks after operation and first data collection period at three

months after operation. Reviewed from the significant results from other

studies, most of the significant different in incontinent status and urinary

symptoms occurred in about four weeks after training or operation. Also, the

high rates (64.9% of intervention group and 61.6% of control group) of

persistent incontinence after 12 months suggested of unrecognized

complication after operation. According to the National Guideline

Clearinghouse (2009), further investigation and treatment were suggested for

patients failed after 6-12 months of first-line conservation management by

21

PFMT.

For secondary outcomes of pelvic floor muscle strength and quality of life,

three trials with evidence levels ranged from 1+ to 2++ showed significant

strengthening of pelvic floor muscle by using digital anal grading with the

modified Oxford scale after 4 weeks (Chang et al., 1998; Porru et al., 2001;

Tibaek et al., 2007). Another two trials did not assess pelvic floor muscle

strength (Hou et al., 2013; Ip, 2004).

In Glazener et al. (2011a), there was no significant different in the pelvic

floor muscle strength was found compared with no PFMT group after 3 months

of PFMT. However, all subjects showed great fall of proportion with

incontinence from 82% to 52% after 3 months of intervention. It may show that

urinary incontinence is a temporary state after TURP. Meanwhile, the review of

this study commented the PFMT information was widely available in the

internet and study area, about 21% in both control and intervention group

subjects had practiced PFMT before randomization even though without formal

teaching by health care professionals. Also, the pelvic floor muscle strength was

measured in intervention groups only; statistically significant between groups

22

would not be determined.

For assessing the subjective impact on quality of life by urinary

incontinence in selected studies, they used different measuring tools without any

consensus. Four studies used three urinary symptoms measuring tools -

International Prostate Symptom Score (IPSS), American Urological Association

Symptom Index (AUA-SI) and Danish Prostatic Symptom Score (DAN-PASS-1)

because all three tools with a separate quality of life score in the questionnaire

(Chang et al., 1998; Hou et al., 2013; Porru et al., 2001; Tibaek, et al., 2007). No

study showed significant different in this area as they were not sensitive to the

urinary incontinence subjects.

Similarly, two studies used two incontinence tools ICIQ-UI SF and St.

George urinary incontinence score; there was one question about quality of life

(Glazener et al., 2011a; Ip, 2004). Finally, both studies did not show any

significant different result after intervention.

On the other hand, general health questionnaire with physical, mental,

psycho-social dimensions showed significant improvement after PFMT in 3

23

studies with evidence levels ranged from 1+ to 2++. The Short Form Health

Survey scale (SF-36) was used in Hou et al. (2013) showed significant

improvement in both physical and mental dimensions after 12 weeks of PFMT.

The Patient satisfaction score in Chang et al. (1998) showed significant

improvement in total score and psychological and social dimensions after 4

weeks of PFMT. The ICS male questionnaire showed significant improvement

after 4 weeks of PFMT (Porru et al., 2001). The European Quality of Life -5

Dimensions (EQ-5D) and Short form-12 health survey (SF-12) were used in

Glazener et al. (2011a), no significant was found at 6 and 12 months after

interventions. General health questionnaires were more sensitive for urinary

incontinence men in assessing their quality of life when compared to urinary

symptoms specific questionnaires. Similarly, two studies did not assess it (Ip,

2004; Tibaek et al., 2007).

In Glazener et al. (2011a), there was no significant difference in both types

of questionnaires in quality of life between the intervention and control groups.

However, the men showed a gradual improvement over time in their quality of

life as showed in the mean ICI-Q score and measures in their quality of life

dimensions in EQ-5D and SF-12 in 3, 6 and 12 months of reviews. It might hint

24

that men undergo gradual recovery from the operation.

For assessing the health economic outcomes by the incremental cost per

quality-adjusted life-year (QALYS) in a study of Glazener et al. (2011a), it

showed significant different between the intervention and control group after 12

months of intensive PFMT.

3. Interventions

In PFMT regime, all studies except one study (Ip, 2004) included an initial

individual assessment of pelvic floor muscle tone by digital anal examination as

Ip (2004) did not mention the mode of delivery of PFMT in details. Only one

individual session for PFMT in four studies showed more significant different

results in pelvic floor muscle strength, incidence of urinary incontinence,

urinary symptoms and general measures of quality of life (Chang et al., 1998;

Hou et al., 2013; Porru et al., 2001) compared to multiple individual or group

teaching sessions by therapists in two studies (Glazener et al., 2011a; Tibaek et

al., 2007). Four studies with evidence levels ranged from 1+ to 2++.

For initiation time of PFMT, men showed earlier significant regaining

25

continence in 1, 2, 3 weeks and significant lengthen voiding interval after 2 and 3

weeks operation in a pre-operative trial with evidence level 1+ (Porru et al.,

2001). In post-operative trials, men showed significant regaining continence

after practicing PFMT in 3 weeks onwards (Chang et al., 1998); men showed

significant improvement in urinary symptoms presented in IPSS in 4 weeks after

PFMT (Hou et al., 2013). That is, men will regain continence or improvement of

urinary symptoms by practicing PFMT earlier before operation.

In the pre-operative study of Tibaek et al. (2007), it showed no significant

different in pre and post-operative initiation of PFMT. It may be explained that

the only one teaching session before operation was not enough for elderly to

catch up the technique, and the exact duration before operation for intervention

was not mentioned in the study as it may greatly affect the recovery time after

PFMT.

For the PFMT content, there was no consensus in six selected studies. But

they exhibited several common characteristics. They must include daily home

practice, slow contraction in 3 positions, and the “knack”, tighten the pelvic

floor muscle strongly after voiding. PFMT with 1-6 times per day, 6-10 series of

26

3-15 slow contractions (evidence levels ranged from 1++ to 2++). After that,

patients’ motivation and compliance are the critical criteria for successful

outcome.

Biofeedback was used in two studies. One study was Glazener et al. (2011a),

evidence level 1++, only 13 of 220 men used biofeedback in this study; another

study was Hou et al. (2013), evidence level 1+, a surface electromyogram (EMG)

was applied to confirm patients doing correct PFMT, no measurement of pelvic

floor muscle strength was performed. In local setting, the use of biofeedback is

optional depends on its availability.

For the types of therapists, there was only one trial with evidence level 1++

for different disciplines of therapists’ comparison, physiotherapists and

continence nurses (Glazener et al., 2011a). It did not show any statistically

significant differences in the attendance of therapeutic sessions or mean

incontinence scores as both disciplines exhibited standard training in the study.

For education tools, all studies included the verbal or in addition of written

instructions for home exercise as they were the basic educational tools. In the

27

study of Ip (2004), evidence level 1-, used a refrigerator magnet as a visual

reminder for exercise to compare the paper copy, the result was inconclusive due

to small sample size from premature call off. However, the patients appreciated

it was a good idea for reminder.

For the bladder training and lifestyle leaflet in addition of PFMT, they were

suggested in two trials (Glazener et al., 2011a; Ip, 2004). But they were not

investigated in these two studies.

4. Period of follow-up sessions and data collection methods

All studies collected data at baseline and intermittent periods after

interventions. Teaching classes, clinical visits, telephone follow up, or postal

questionnaire were used to monitor and record patients’ progress and their

compliance. The duration ranged from weekly in first four weeks and up to 12

months. After reviewing the selected studies, follow-up or data collection in

four weeks and 12 weeks got the most significant different results.

2.3.4. Recommendations

After the critical review of the evidence, benefits of PFMT and incidence of

28

regaining urinary continence was demonstrated in some selected studies, it was

helpful to draw out recommendations. Appendix 8 showed tables of

recommendation from synthesis process.

(1) Target group will be men with BPH and had undergone TURP. They were not

planned or received bradytherapy. They did not have urethral or pelvic

surgery; and not suffering from neurological diseases or cognitive

impairment. They can be communicated and understood the therapists’

instruction for PFMT.

(2) Assessment and outcome measures

The ICI-UI SF and voiding diary were recommended assessment tools

for urinary incontinence. The AUA-SI and IPSS were similar in meaning with

the identical grading method, either one of them was recommended to use in

assessing severity of urinary symptoms. Voiding and storage parameters by

uroflowmetry and bladder scan were suggested to quantity the severity of

urinary symptoms and to monitor patients’ progress of treatment. Modified

Oxford Scale was recommended to assess the pelvic floor muscle strength. For

generic health assessment, physical, psycho-social and emotional dimensions

29

were recommended. A commonly used, well-validated with a Chinese version

of questionnaire is the major chosen criteria for the local study.

(3) Intervention

An individual baseline assessment and teaching session was

recommended. PFMT was suggested to start as soon as possible before

surgery to help patients regain continence earlier. In regime of PFMT,

strong contractions in lying, sitting and standing positions, the “knack” and

tightening the pelvic floor muscles strongly after voiding were

recommended. Nurses with specialized experience in incontinence will be

recommended as therapist as they will follow-up patients from

pre-operative to post-operative and provide an integrated care planning and

related home advice to patients as a whole. Verbal and written instructions

for home exercise, a visual reminder such as a refrigerator magnet was

recommended to increase PFMT compliance. In addition of PFMT, bladder

training and lifestyle leaflet were suggested.

(4) Duration and mode of follow up sessions

Follow up at 2, 4 and 12 weeks after operation or discharge was

30

suggested to monitor their progress and to increase their compliance of

PFMT. In local setting, the duration and mode of follow-up will greatly

depend on the availability of the manpower and budget. Multiple teaching

follow up sessions can be applied to the setting with the information of

PFMT is not widely available in the society or targeted to special age group

- elderly. Elders are not easily catch up the technique of contractions

without professional health care instruction.

31

Chapter 3

Translation and Application

After reviewed and identified the best practices, this chapter is going to

discuss the implantation potential, transferability of the findings and feasibility

of the reviewed studies in local clinical setting. Then, an evidence-based practice

guideline of pelvic floor muscle training program is introduced.

3.1 Implementation Potential

The proposed program is the pelvic floor muscle training (PFMT) program

to reduce urinary incontinence for patients undergoing transurethral resection of

prostate (TURP). In the above review, it is shown that the PFMT program can

reduce urinary incontinence and increase quality of life in men after TURP. This

effective program is proposed to be translated into local practice. Before

implementation, the target setting and audience, the transferability of the

findings, feasibility and cost-benefit ratio of the proposed program will be

examined.

32

3.1.1 Target setting

The proposed pilot PFMT program will be implemented in a 42 beds

urology in-patient ward and a 31 beds day ward in an acute hospital under the

Hospital Authority.

3.1.2 Target audience

The target audiences of the innovation are all patients who are scheduled for

elective TURP within at least one week before operation and have pre-operative

assessment (PAS) in day ward as they will have sufficient time for exercise

education and practicing at home before operation. They must be mentally-fit

and capable of independent daily living activities as they must have the ability to

learn and practice the exercise. There is no limitation of age. All participants

fulfill the selection criteria and give the consent to the pilot program.

The exclusion criteria are men planned or receiving bradytherapy, with

urethral or pelvic surgery, suffering from any neurological or cognitive

impairment.

33

3.2 Transferability of the Findings

Transferability refers to whether the selected research findings can fit into

the local clinical practice. It is explored as below.

3.2.1 Setting

The target setting of innovation and reviewed studies are done in hospital.

In the reviewed studies, the training program was supervised by nurses or

physiotherapists. Similarly, the proposed program will be implemented by

nurses working in the urology and day wards. Two Advanced Practice Nurses

(APN) – urology nurses, who are qualified from urology training, will be

responsible for implementation of the proposed program before and after

operation.

3.2.1 Characteristics of patients

Characteristics of the target audience match greatly with the participants in

all reviewed studies in which they were men, aged between 45 and 79, who were

undergoing TURP. Most of them were elderly because of the etiology of the

disease. The participants in the review studies were predominantly Caucasians

but two reviewed studies were conducted in Chinese population (Chang et al.,

34

1998; Hou et al., 2013). Since the studies in Chinese population also obtained

significant positive outcomes, cultural difference may seemingly not a huge

concern.

3.2.3 Philosophy of care

The innovation and the review studies are congruent in philosophy of care.

They aim to help patients to reduce urinary incontinence or regain urinary

continence, and increase their quality of life ultimately. Similarly, the mission of

the target setting is to excel in the provision of holistic patient-centered quality

care to help people stay healthy (Hospital Authority, 2013a).

3.2.4 Sufficiency of clients benefit from the innovation

According to the retrospective clinical observation from September 2012 to

August 2013, there were 11 of 15 patients underwent elective TURP with the

PAS per month. There will be 66 patients benefited in the 6 month - pilot training

program.

3.2.5 Time schedule for implementation and evaluation

During the implementation of the program, nurses in urology and day wards

35

are the main conductors of PFMT for men undergoing TURP. Urology nurses in

day ward will provide pre-operative PFMT when patient having urine and blood

investigations at least two weeks before operation. Then nurses will review

patients about one week before operation when they admit to day ward for PAS.

After operation, nurses in urology ward will reinforce them to practice PFMT on

discharge and arrange urology nurses’ follow-up. Two interview sessions before

operation and one session on discharge have to help patients especially elderly to

catch up the PFMT technique and increase their compliance. Then patient will

follow up at 4th

and 12th

week after operation, which is similar to the majority of

the selected studies.

3.3 Feasibility

Feasibility of the innovation is more practical concerns which may involve

the organization climate, availability of manpower and resources in clinical

setting. Patients have right to terminate the program when it is considered

undesirable.

3.3.1 Interference on current staff functions

Incorporation of the proposed program into the services of the TURP

36

patients, the time and workload of interviewing and assessment are expected to

increase. However, PFMT will decrease the number of telephone enquiry and

medical consultation relate to urinary incontinence after TURP.

From the above estimation, only 11 target patients will join per month. The

risk of conflict among nurses is low as it will not significantly increase their

workload to provide an individual 30 minutes training session in their first

attendances. Then, nurses only need to remind the steps and importance of

practice with the help of refrigerator magnet in the follow-up sessions which may

spend about 15 minutes in each follow-up session. Currently, nurses are

providing PFMT to patients with radical prostatectomy; it will not greatly

interfere on current staff functions.

3.3.2 Administration and resources support

Administration support is important for the success of the innovation. The

key is to communicate with urologists and gaining their support for the innovation

because its low cost and high benefit with the minimal risk to the patients.

Since nurses work in urology and day wards are providing PFMT education

37

to patients with radical prostatectomy, urology nurses will conduct two identical

one hour-briefing sessions introduce this training and evaluation program.

There is no special equipment is required for the program. An information

leaflet and a refrigerator magnet will be given to the patient. Measuring tools for

outcome evaluation are commonly available. The PFMT will be carried in a

consultation room in day ward and an interview room in urology ward. Patients

will follow-up in the urology nurse clinic to evaluate their outcomes. All of the

facilities are currently available.

3.4 Cost-benefit Ratio of the innovation

The cost-benefit ratio of the proposed program must be assessed before the

implementation.

3.4.1 Potential risks and benefits of the innovation

The potential risk expose to patients is minimal. PFMT is a safe, first

conservation management for patient with urinary incontinence after TURP

(Harris, 1997; Bauer et al., 2009). Meanwhile, all patients will enroll in the

innovation program after assessment from the doctors and nurses in order to

38

minimize the potential risk.

Patient will benefit from the innovation as they may reduce the risk of

urinary incontinence or regain continence earlier after TURP. Patients’ hospital

stay will shorten and reduce their complications related urinary incontinence.

They will achieve better quality of life.

3.4.2 Disadvantage of maintaining current practice

At present, some nurses and doctors advice patients to perform PFMT when

they had urinary incontinence after TURP. Patients are suffering from a period of

urinary incontinence as PFMT needs to take a period of time to be effective. It

greatly worsens their quality of life even after operation.

Also, we only provide a brief PFMT by means of verbal and written

instruction only. Learning the right technique and practicing at home are two key

elements in PFMT. Majority of patients for TURP are elderly, they require more

instructions, demonstration and encouragement in learning new things.

Otherwise, they will abandon the exercise and suffer from urinary incontinence.

They become social isolated and depressed.

39

3.4.3 Material costs of implementing the innovation

The majority of the budget will be spent on the salary of the nurses. There

are four contact times between patients and nurses during the program. In the

first contact time will be 30 minutes, the following 3 contacts will spend about 15

minutes each time. Totally nurses will spend about 75 minutes to each patient.

The urology nurses will attend patients in first and last visits.

According to the Master Pay Scale (Civil Service Bureau, 2013), the mean

monthly salary with allowances of a Registered nurse (RN) is HK$36,348 and an

APN is HK$57,662. They are working for 190 hours per month. The total cost is

calculated as follows:

Mean salary of a RN is HK$3.19 per minute (HK$36,348 ÷190 ÷ 60 =

HK$3.19/ minute).

Mean salary of an APN is HK$5.06 per minute (HK$57,662 ÷ 190 ÷ 60 =

HK$5.06/ minute).

Cost for nursing manpower for one patient is HK$323.40 (HK$3.19 x 30

minutes + HK$5.06 x 45 minutes = HK$323.40).

40

Total cost for 6 months is HK$21,344.40 (HK$323.40 x 11 patients x 6

months = HK$21,344.40).

Other than that, the material costs are low because no additional equipment

is required to be purchased. The printing costs of information leaflets, consent

forms, questionnaires and assessment forms of the proposed program are low as

the printing service is available in the hospital. One hundred of refrigerator

magnets will be prepared due to the minimum order in the market; they only cost

about HK$300. It is estimated that for a short-term 6 months implementation of

the proposed program will cost about HK$21,644.40.

3.4.4 Material costs of not implementing the innovation

If the innovation is not implemented, patients will suffer from urinary

incontinence and seek medical service. An average health care service of a

patient is one day hospital stay and three times of out-patient follow-up. The

estimated cost of one day acute care hospital stay is HK$4,680 and one

attendance at a specialist clinic is HK$1,110 (Hospital Authority, 2013b). The

minimum cost for 6 months will be: [HK$4,680 + (HK$1,110 x 3 times)] x 11

patients x 6 months = HK$528,660. Meanwhile, medication for urinary

41

incontinence and the loss of hospital reputation were uncountable cost.

3.4.5 Potential non-material costs and benefits of implementing the

innovation

The potential non-material costs will be increased nurses’ workload and

stress in learning and adapting the proposed program. It is an extended service

from patients with radical prostatectomy to TURP. If the innovation comes with

a good communication plan with adequate training and information provided to

nurses before implementation can greatly reduce their stress.

Meanwhile, it gains better nurse-patient trusting relationship with

appreciation from patients due to better commitment and quality of care. For

hospital, it may reduce the rate of telephone enquiry, clinical follow-up and

workload of health care professionals. For nurse professional, it may help to

increase nurse autonomy, morale and job satisfaction as it is a nurse-led service.

3.4.6 Cost-benefit ratio

The cost-benefit ratio is HK$21,644.40 / HK$528,660 = 0.04, and the

uncountable costs are not included. As the cost-benefit ratio is less than 1, this

42

innovation is worth to implement.

In conclusion, the innovation can be implemented because of its

transferability, feasibility and cost-effectiveness.

3.5 Evidence-Based Practice Guideline

After affirming the potential of implementing this innovation, an

evidence-based guideline is developed based on the selected studies in the

previous section.

3.5.1. Title of the guideline

The title is “An evidence-based pelvic floor muscle training program to

reduce urinary incontinence for patients undergoing transurethral resection of

prostate”.

3.5.2. Aim and objectives of the guideline

The aim of the guideline is to provide an evidence-based pelvic floor

muscle training program to nurses to reduce urinary incontinence for patients

undergoing TURP.

43

The objectives are:

(1) To formulate clinical practice instructions for the patient to regain urinary

continence after TURP based on the best evidence available;

(2) To reduce the complications related to post-operative urinary incontinence

by practicing PFMT;

(3) To standardize the PFMT process of patient undergoing TURP.

3.5.3. Target group

The target participants of the innovation are men who are scheduled for

elective TURP within at least one week before operation and have PAS in day

ward to ensure they have sufficient time for exercise education and practicing at

home before operation. They must be mentally-fit and capable of independent

daily living activities. The exclusion criteria are men planned or receiving

bradytherapy, with urethral or pelvic surgery, suffering from any neurological or

cognitive impairment.

3.5.4. Recommendations

The SIGN (2013a) grading system (Appendix 2) will be used to grade the

44

recommendation as follow:

Recommendations are divided into four parts:

(1) Assessment and outcome measurements

(2) Pelvic floor muscle training instruction

(3) Patient education tools

(4) Frequency of follow-up sessions

(1) Assessment and outcome measurements

Recommendation 1.1: Baseline assessment on urinary incontinence and urinary

symptoms should be performed before TURP. (Grade A)

Patients undergoing TURP may worsen their urinary symptoms and become

urinary incontinence. All the reviewed studies performed baseline assessment to

measure the progress of the urinary symptoms and degree of urinary

incontinence, four studies showed improved urinary or incontinence status

(Chang et al., 1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013 (1-);

Porru et al., 2001 (1+)).

45

Recommendation 1.2: Baseline assessment on the strength of pelvic floor muscle

should be performed before TURP. (Grade A)

Four of the six studies measured the pelvic floor muscle strength by

Modified Oxford scale to monitor progress of treatment. Three studies showed

improved muscle strength after 4 weeks PFMT (Chang et al., 1998 (2++); Porru

et al., 2001 (1+); Tibaek et al., 2007 (1+)).

Recommendation 1.3: General health questionnaires which consist of physical,

psycho-social and emotional dimensions are suggested for assessment the

impact of quality of life related to urinary incontinence. (Grade A)

General health questionnaires which consist of physical, psycho-social and

emotional dimensions were more sensitive in measuring the impact of quality of

life related to urinary incontinence. In Chang et al. (1998) (2++), the total,

psycho and social patient satisfaction scores were improved after PFMT. In Hou

et al. (2013) (1-), both the physical and mental dimensions in the Short Form

Health Survey scale (SF-36) showed improvement after PFMT. In Porru et al.

(2001) (1+), the ICS male questionnaire showed improvement after PFMT. Then,

46

a commonly used, well-validated with a Chinese version of general health

questionnaire is recommended for local practice.

(2) Pelvic floor muscle training instruction

Recommendation 2.1: Conduct a first teaching session on PFMT by trained

health care professional individually. (Grade A)

First teaching session on PFMT should be conducted by trained health care

professionals individually to ensure patient understand and perform it correctly,

clarify any worries to increase their compliance rate (Chang et al., 1998 (2++);

Glazener, et al., 2011a (1++); Hou et al., 2013 (1-); Porru et al., 2001 (1+);

Tibaek et al., 2007 (1+)).

Recommendation 2.2: The strength of pelvic floor muscle contraction should be

assessed and taught by digital anal examination with verbal feedback. (Grade A)

Digital anal examination with verbal feedback is the key step in learning the

correct PFMT. It helps patients control the pelvic floor muscles while keeping

the abdominal muscle relaxed with positive feedback from nurses (Chang et al.,

47

1998 (2++); Glazener et al., 2011a (1++); Hou et al., 2013; Porru et al., 2001;

Tibaek et al., 2007).

Recommendation 2.3: Patients should be educated for PFMT as soon as before

TURP. (Grade A)

Patients showed regain urinary continence earlier and increase voiding

interval when practicing PFMT before TURP than those of practicing after

operation. In Porru et al. (2001) (1+) pre-operative PFMT study, patients showed

the earliest improvement of urinary incontinence in voiding diaries after first

week of operation. In post-operative PFMT studies, patients got improvement in

urinary symptoms after 3 weeks and 4 weeks of operation in Chang et al. (1998)

(2++) and Hou et al. (2013) (1-) studies respectively; patients regained urinary

continence at 3 months after PFMT in Glazener et al., (2011a) (1++) study.

Recommendation 2.4: Patients should practice PFMT in three positions with 1-6

times per days and the “knack” at home. (Grade A)

After reviewing of selected studies, there shared several common contents

48

irrespective of no standardized duration and frequent of contractions in PFMT

regime. They consisted of practicing slow contractions in lying, sitting and

standing positions for 1-6 times per day, 6-10 series of 3-15 slow contractions,

duration of each contraction was set up to a maximum of 10 seconds according to

patients’ muscle strength (Chang et al., 1998 (2++); Glazener et al., 2011a (1++);

Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007

(1+)).

Two studies included “knack” practice in PFMT to reduce the risk of urinary

incontinence in daily life (Glazener, et al., 2013 (1++); Tibaek et al., 2007 (1+)).

“Knack”, tighten the pelvic floor muscle strongly before and during any event

which might cause leaking such as coughing and rising from sitting.

(3) Patient education tools

Recommendation 3.1: Verbal and written instructions of PFMT should be given

to patients for home practice. (Grade A)

All the reviewed studies provided verbal and written instruction to patients

for home practice. It is helpful to remind the technique of PFMT and increase

49

their compliance rate for the elderly patients (Chang et al., 1998 (2++); Glazener

et al., 2011a (1++); Hou et al., 2013 (1-); Ip, 2004 (1-); Porru et al., 2001 (1+);

Tibaek et al., 2007(1+)).

Recommendation 3.2: Visual reminder acts as a reminder to practice PFMT at

home. (Grade C)

A visual reminder such as a refrigerator magnet which contains information

on how to perform the PFMT was given to patients to increase their compliance

rate. In Ip (2004) (1-), patients demonstrated higher compliance rate of PFMT at

2 weeks after operation in magnet group but they are not demonstrated at 3

months after operation. However, patients appreciated it was a good reminder.

Therefore, this visual reminder pairs with early pre-operative PFMT will exhibit

greater effect.

(4) Frequency of follow-up sessions

Recommendation 4.1: After initial PFMT pre-operative teaching session, a

reminder session before discharge and a follow-up at 4th

week after operation are

suggested to monitor patients’ progress. (Grade A).

50

In the reviewed studies, re-education program of PFMT was important after

operation to clarify any misconceptions and reinforce their compliance. All

reviewed studies except Glazener et al. (2011a) conducted post-operative PFMT

before discharge (Chang et al., 1998 (2++); Hou et al., 2013 (1-); Ip, 2004 (1-);

Porru et al., 2001 (1+); Tibaek et al., 2007(1+)).

The most frequent duration of follow-up sessions were at 2nd

, 4th

and 12th

weeks after operation in the reviewed studies. However, the 4th

week session got

the most significant improvement of urinary incontinence, urinary symptoms,

pelvic floor muscle strength and quality of life (Chang et al., 1998 (2++); Hou et

al., 2013 (1-); Porru et al., 2001 (1+); Tibaek et al., 2007(1+)). After that, the

frequency of follow-up sessions depends on the availability of manpower and

budget.

Summary of the above recommendations was shown in Appendix 9.

51

Chapter 4

Implementation Plan

After development of an evidence-based guideline in the previous chapter,

nurses of a local acute hospital are advised to conduct pelvic floor muscle

training with patients undergoing transurethral resection of prostate. A clear and

detailed implementation plan, which includes a communication plan, a pilot

study plan and an evaluation plan, is described.

4.1 Communication Plan

In the communication plan, potential stakeholders will be identified and

related communication process will be discussed.

4.1.1 Identifying the stakeholders

Stakeholders should be identified before formulating the communication

plan. There are five major groups of stakeholders anticipated in this innovation.

52

Firstly, stakeholders at the administrative level are most powerful and

influential. The Consultant of the Urology team, the Department Operational

Manager (DOM) and Ward Managers (WMs) of day ward and urology ward are

responsible for monitoring and managing the quality of care in the setting. They

decide whether the proposed program will be funded or approved. Getting their

supports help to implement and run the proposed program efficiently as they can

act as a liaison among all staffs and have ability to coordinate and assign work to

staff in the innovation.

Secondly, urology nurses in day ward are responsible for providing

pre-operative assessment and investigations to patients with elective urology

operations. They are the main program conductors. They are directly affect and

are responsible for the implementation of the proposed program. Gaining of their

support is vital for the innovation. They are responsible for promotion of quality

of life by gaining urinary continence and reducing post-operative complications.

Thirdly, all urology doctors will be involved in the program, and the

Consultant of the Urology team will be invited to be an adviser on the program.

Doctors are collaborative partners in the innovation as they are responsible to

53

introduce the program to potential patients, answer their questions and arrange

patients admitted to pilot day ward one week before TURP for pre-operative

assessment. After TURP, doctors arrange combine follow-up appointments with

urology nurses to those patients.

Fourthly, nurses in day ward and urology ward are conductors of the

innovation. The workload and stress may be increased because they need to

acquire knowledge and skills and integrate the innovation into their nursing care.

The difficulty is not large as the education of PFMT is extended from radical

prostatectomy patients to TURP patients. To reduce any resistance, details of the

program will be disseminated and time allowed for review will be available to

them; and education sessions with demonstration will be given to them.

Lastly, men who will be referred to the proposed program by doctors or

nurses are stakeholders of the program. They are being informed of their right to

choose whether to join the proposed program.

4.1.2 The communication process

The process of the communication includes communication sequences of

54

the stakeholders and how to initiate, guide and sustain the change.

The program coordinator is a key person in communicating with different

stakeholders and responsible for providing a clear vision of the program and its

aims, needs and significance, the best evidence from a wide range critical

appraisal review, and its transferability, feasibility and cost-benefit analysis.

The urology nurse is the first person to be contacted informally as he will be

the major program conductor. As mentioned before, gaining his support is the

key success of the program. A full written proposal and guideline emphasized the

importance of the development of an evidence-based PFMT program to reduce

urinary incontinence for patients undergoing TURP will be given to him.

Recommendations may be obtained from him who is useful to finalize the pilot

study proposal. Then, the proposed program will be presented to the

administrators along with him.

A formal meeting will be arranged with the WMs of the day ward and

urology ward, and the DOM. A clear and precise power point presentation with a

55

written proposal will be prepared to communicate. A meeting with the

Consultant of the Urology team will be arranged after gaining their operational

approval. As they are the budget holders, the cost-benefit ratio of the proposed

program will be illustrated in the meetings.

After gaining their support, the information of the proposed program will be

disseminated to the urology doctors, WMs, urology nurses and frontline nurses

who will be involved. A formal departmental meeting will be arranged to

disseminate the information of the proposed program to the nurses and doctors,

which is held every three months. Also, the information of the proposed program

will be disseminated via multiple channels which are include internal e-mails

and ward briefing sessions as well.

4.1.3 Initiating, guiding and sustaining the change

To initiate the proposed change, a working group will be formed to

facilitate communication between nurses in different working areas and provide

feedback to improve the nursing practice. It includes four members, program

coordinator, urology nurse and one nurse representative from day ward and

urology ward.

56

The aims of the innovation are clearly stated that patients will not develop

urinary incontinence or will regain urinary continence after PFMT. An

evidenced-based guideline was developed with the wide ranged critical review

showing that PFMT is an effective conservative treatment for TURP patients. A

pocket guide with aims, guideline and patient journey of the innovation will be

designed and distributed for quick references.

To implement the innovation, an action plan with a clear time frame will be

established. In the program, obtaining approval from the above stakeholders will

last for three months. Then, a three-month pilot study will be implemented to test

the guideline and evaluate the proposed changes.

Before the pilot study, two identical one hour briefing sessions introduce

PFMT and the evaluation of the muscle strength; and the program details will be

given to all involved nurses. It is provided by urology nurses and organized by

the program coordinator. Ward conferences will be held monthly to provide

educational and feedback channels. Besides, the logistic arrangements for the

design and adequate supply of the pocket guide, information leaflet, posters and

57

refrigerator magnets are the responsibility of the working group.

In order to ensure the sustainability of the proposed program, the working

group will monitor and evaluate the effectiveness of the proposed change

continuously by observing patient outcomes such as incident rate, severity of

urinary incontinence, quality of life and satisfaction. Also, observing nurse’s

outcomes in self-perceived skill, confidence level and satisfaction with the new

guideline by means of questionnaires. If the pilot program showed significant

benefit to those patients, the program will be promoted to all patients receiving

TURP in the hospital.

4.2 Pilot Study Plan

A 6-month pilot study will perform before the full-scale implementation of

the program. Before the pilot study, all nurses in the pilot wards will be

completely trained by lecture and ward conferences. However, only nurses with

more than five years of experience will be recruited in this pilot study. There are

26 nurses in the pilot wards, of whom 13 nurses have more than five years of

experience. To ensure the reliability, all nurses must pass the practical

assessment on PFMT by urology nurses. Also, they must be evaluated to ensure

58

understanding of the measurement and evaluation tools.

It will be carried in a urology ward and a day ward respective to the

workflow. If the patients admitted for elective TURP with at least one week

pre-admission assessment in day ward and meet the required eligibility criteria

of cognitive intact and able to understand the instructions, they will become

target participants. If patients were planned or receiving bradytherapy, with

urethral or pelvic surgery, suffering from neurological disease or cognitive

impairment will be excluded in this study.

Also, the measuring and evaluation tools will be tested to evaluate the

outcome effectively and accurately. They include voiding diary, the International

Consultation on Incontinence Modular Questionnaire - Urinary Incontinence

Short Form in English (ICIQ-UI SF) (Appendix 10) and the validated Chinese

version (Appendix 11); and pelvic floor muscle strength assessment by using

Modified Oxford Scale. Nurses will record patients’ incontinence status and

pelvic floor muscle strength before operation and patient progress in patient

progress form after operation. Patients will be followed up at 4th

and 12th

week

after operation. Then, the compliance of nurses and patients will be monitored by

59

patient progress form.

For nurses, they can bring out their concerns or difficulties through monthly

ward conferences and evaluation questionnaire as well. A questionnaire

concerning the self-perceived level of competency in skills and knowledge in

implementing the program and the satisfactory level of the program is designed

(Appendix 12).

After the pilot study, the proposed innovation will be reviewed according to

the collected data about the patients’ outcomes and nurses’ concern, logistic

supply and usage of resources. A formal meeting will be held to explain any

modification made to the program and announce full-scale implementation in the

pilot urology and day wards.

4.3 Evaluation Plan

The evaluation plan is to examine the effectiveness of the program and to

evaluate the clinical benefits of the proposed program.

60

4.3.1 Nature of clients to be involved

The inclusion and exclusion criteria for patients to be evaluated are the

same as the pilot study plan and based on the identified evaluation studies. All

the recruited patients will be evaluated. Also, all nurses working in the urology

and day wards; and two urology nurses are the conductors of the program. They

are subject to be evaluated.

4.3.2 Outcomes measurement

The patient, healthcare provider and program outcomes will be measured in

order to examine whether the program will achieve its objectives and clinical

benefits.

Patient outcomes

The primary outcome of this innovation program is the continence rate;

other two secondary outcomes are the severity of urinary incontinence and the

impact on quality of life of urinary incontinence.

Based on the reviewed studies, the continence rate was mostly measured by

self-reporting 48 hours voiding diary (Chang et al., 1998; Glazener et al., 2011;

61

Hou et al., 2013; Porru et al., 2001). Patients need to return their voiding diaries

on the day of pre-admission assessment in day ward and follow-ups in clinic at

4th

and 12th

week after discharge (Chang et al., 1998; Hou et al., 2013; Porru et al.,

2001). Patients will be defined as continence if no leaking of urine was noted.

In addition, the severity and frequency of the incontinence are measured in

voiding diary and the ICIQ-UI SF. Simultaneously, ICIQ-UI SF measures the

impact of urinary incontinence to quality of life (Glazener et al., 2011).

ICIQ-UI SF has been fully validated and published; it gets a grade “A”

highly recommended self-reporting tool in evaluating the severity of urinary

incontinence and the impact of symptoms of urinary incontinence on quality of

life and outcome of treatment (Abrams et al., 2006).

ICIQ-UI SF mainly consists of 4 brief questions. One of the questions will

ask patient about the impact of everyday life, score (1-10). The lowest score

reflects the least impact on quality of life related to urinary incontinence. Finally,

an ICIQ score (0-21) yield from questions. The highest score reflects the highest

frequency and the largest amount of urinary incontinence with the greatest

62

impact on quality of life.

Questionnaire is self-reported by patient or with the help of a nurse to ask

him the questions. Measurements are taken on the day of pre-admission

assessment and at 4th

and 12th

weeks post-operatively (Chang et al., 1998;

Glazener et al., 2011; Hou et al., 2013; Porru et al., 2001).

Healthcare provider outcomes

The healthcare provider outcomes of self-perceived level of competency in

skills and knowledge in implementing the program, and satisfactory level of the

program are measured by a self-designed questionnaire (Appendix 12).

Questionnaires will be collected after the training sessions and the

implementation of the pilot program. Personal identification information is not

included in the questionnaire to ensure honest response.

Program outcomes

To measure program effectiveness, the utilization of the program, assigned

manpower and costs evaluation are the basic measures. The program utilization

rate will be calculated by the number of patients who are willing to join the

63

program over all eligible patients. Also, patients’ attendance and attrition rates

will be used for measuring utilization rate. The patient progress form, from

pre-admission assessment to post-operative follow up, will be used to evaluate

the utilization of the program. Nurses need to enter the information about

patients’ attendance, voiding diary, pelvic muscle strength assessment and the

practice of pelvic floor muscle exercise at home. Also, nurses need to record the

education and advice given in every session of interview and on day of

discharge.

The actual costs of the program will be calculated. The material cost of the

program is low; it is mainly from the design and photocopying of the information

sheets, posters, patient progress forms and the refrigerator magnets. Manpower

is the major expenses in the program. It will be measured from the patient

progress form which will be collected after the implementation of the pilot

program. All the expenditure will be carefully recorded and controlled as a base

of the full implementation of the program.

4.3.3 Number of patients to be involved

The number of patients to be involved depends on the primary outcome of

64

the program and the data analysis method. This study is a pre-test and post-test

design, two-tailed paired t-tests will be used for the calculation of the sample size.

The program is to determine the continence rate is changed since the

implementation of the innovation.

From the reviewed study (Porru et al., 2001), the continence rate in 3 weeks

(80% vs 12.8%), with the power set at 90% and the level of significance at 0.01,

the number of patients was 22. The dropout rate was 5.17% in 4 weeks, that is,

the sample size will be 23.2 patients. In the three reviewed studies with 12 weeks

program, the dropout rates ranged from 0 to 15.52% (Hou et al., 2013; Ip, 2004;

Tibaek et al., 2007).

From the previous data, there were about 11 patients underwent elective

TURP with the pre-admission system per month; of which, 26 patients will be

required for 15.52% dropout rate in a 12 weeks program. It is estimated that

recruitment of 52 patients in the 12 weeks program would take about 6 months.

4.3.4 Data analysis

The primary outcome – continence rate is the proportion of patients whose

65

urine loss is zero as recorded in 48 hours voiding diary. The increased percentage

of patient getting continence indicates the degree of effectiveness of this

program.

The severity of urinary incontinence is measured in one of the question in

ICIQ-UI SF. It is categorized into four degrees and scores (0-6), none (0), a small

amount (2), a moderate amount (4) and a large amount (6). The program is

considered effective if the mean score decreased.

The degree of impact of urinary incontinence affects patients’ quality of life

was indicated in one of the question in ICIQ-UI SF. It is a 10 point scale; the

lowest point means not a trouble, the highest point mean a great trouble in daily

life. Finally, an ICIQ (0-21) score is the sum score of the ICIQ-UI SF. The

decrease of these mean scores indicates the success of the program.

Descriptive statistics will be used to summarize patients’ demographic data.

In addition, pre- and post-interventions will be analyzed by paired t-tests. They

will apply to detect the mean change in frequency and amount of urine loss,

degree of impact in daily quality of life, ICIQ score, pelvic floor muscle strength,

66

patients’ average time for exercise per week in cycle, patients’ and nurses’

satisfaction level, nurses’ self-perceived skill and confidence level.

4.3.5 Criteria for considering the program effective

The program will be considered as effective if the outcomes are achieved.

Since the primary outcome of the program is urine continence, if the mean of

continence rate is increased after 12 weeks of PFMT program, the program will

be considered effective.

The program will also be considered effective if it shows a statistically

significant positive effect on the patients’ mean change of the amount of urine

loss, impact of the quality of life score and the ICIQ score. At least 70% of the

patient progress form is fully completed.

In addition, the program will also be considered as effective if 70% or more

of patients and nurses choose “agree” or above in the questionnaire for their

satisfaction level; and achieved 80% of nurses choose “agree” or above in the

self-perceived skill and confidence level.

67

For the utilization of the program, the program will be considered as

effective if 70% or more of the eligible patients show their willingness to join the

program, patients’ attendance rate is higher than or equal to 70%, and the patients’

attrition rate is less than or equal to 15%. For the costs of the program, if the total

expenditure of the program is within the budget limit, the program will be

considered as effective.

68

Chapter 5

Conclusion

In conclusion, this thesis proposes an evidence-based pelvic floor muscle

training program to reduce urinary incontinence for patients undergoing

transurethral resection of prostate in a local acute hospital. It aims to reduce the

complications related to post-operative urinary incontinence by practicing

PFMT and to improve their quality of life.

The development of the guideline is brought through the systematic

literature searching and quality assessment of the reviewed articles. Articles

include five RCTs and one controlled trial.

The proposed PFMT program is affirmed its implementation potential. It is

analysed and resulted with high local transferability and feasibility, and low

cost-benefit ratio. Also, the potential risk exposes to patients is minimal. It is

worth to implement it in local clinical setting as discussed.

69

Based on the reviewed studies and local clinical setting, the evidence-based

PFMT guideline is developed based on four parts. They are assessment and

outcome measurements, PFMT instructions, patient education tools and

frequency of follow-up sessions. After that, an implementation plan which

includes a communication plan, a pilot study plan and an evaluation plan are

designed to guide its implementation in the local clinical setting.

Finally, it hopes that the developed evidence-based PFMT program can

provide healthcare providers, especially nurses, with an evidence-based

approach to promote PFMT to reduce the duration or amount of urinary

incontinence for patients after TURP and improve their quality of life. In turns, it

reduce the social and health burden of the society.

70

List of Appendices

Appendix 1: Search Strategies and Result

A search of literature was conducted on 18 August 2013.

Item

No.

Database

Keyword

CINAHL

Plus

(1993 - 18

August

2013)

PubMed

(1993 - 18

August

2013)

Science

Direct

(1993 -

18 August

2013)

British

Nursing

Index

(1993 - 18

August 2013)

#1 Prostate 15048 127160 209142 688

#2 Urinary incontinence 6612 32816 38119 799

#3 Pelvic floor 1890 8365 24202 215

#4 #1 and #2 and #3 1 96 1724 8

#5 Transurethral resection

of prostate

5217 10319

#6 #4 and #5 17

462

#7 Benign prostate

hyperplasia

37338

#8 Pelvic floor muscle

exercise

4459

#9 #6 and #7 288

#10 #8 and #9 112

Selected articles after

screening title and

abstract

1 6 2 2

Selected articles after

screening full paper

with inclusion and

exclusion criteria

1 6

2

2

Total number of trials

selected after singling

out duplicated studies

6 randomized controlled trials

71

Appendix 2:

Table of the Scottish Intercollegiate Guidelines Network (SIGN) Grading

System

Levels of Evidence

Level Description

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of

bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or bias

and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or bias and

a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a significant

risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

Grades of Recommendations

A At least one meta-analysis, systematic review, or RCT rated as 1++, and directly

applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the

target population, and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++, directly applicable to the target

population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+

Good practice points

Recommended best practice based on the clinical experience of the guideline development

group

72

Appendix 3: Tables of Evidence

Bibliographic

citation

Study type

Evidence

level

Number of

patients

Patient

characteristics

Intervention Comparison Length of

follow up

Outcome measures Effect size

Intervention vs Comparison

Chang et al.

(1998)

Controlled

trial

2++

N = 50

Dropout: 0

The first 25

men served

as a control

group, the

next 25 men

were the

intervention

group

Men with BPH

underwent TURP.

Inclusion criteria:

Age < 80 years,

frequency, terminal

dribbling, urinary

incontinence,

ambulatory and

communicable.

Exclusion criteria:

pelvic surgery,

urethral surgery,

neurogenic bladder.

n = 25

- Perform PFMT

every day after

removal of

urinary

catheter in 1-2

days after

operation

- Attend clinic

weekly for

evaluating

PFMT

- PFMT daily at

home

- Mean age = 65

(51 – 74) years

n = 25

- No PFMT

- Mean age =

64 (45-79)

years

(a) Before

operation

(b)1 week

(c) 2 week

(d) 3 week

(e) 4 week

after

operation

(1) Men with

incontinence

(2)Men with

terminal

dribbling

(3)AUA symptom

score

(4)Pelvic floor

muscle strength

(5) Uroflowmetry

parameters

(6)Voiding interval

(minutes)

(7)Patient

satisfaction

score:

(1d) 1 vs 9 (p < 0.05)

(1e) 1 vs 8 (p < 0.05)

(2e) 3 vs 10 (p < 0.05)

(3a) 23 vs 22

(3b) 11 vs 10

(4e) Grade 1: -8% (p < 0.05)

Grade 2: -3% (p < 0.05)

Grade 3: 0% (p < 0.05)

Grade 4: 5% (p < 0.05)

(5) No significant difference

(6b) 30.4 (p < 0.01)

(6c) 43.2 (p < 0.01)

(6d) 41.6 (p < 0.01)

(6e) 43.4 (p < 0.01)

(7e) (i) -4.36 (p < 0.01)

(ii) -1.12

73

(i) total score

(ii) emotional

(iii) psychological

& social

(iv) physical

(iii) -2.89 (p < 0.01)

(iv) -0.84

General comment:

- Pelvic floor muscle strength- digital rectal examination, grade (0, none – 4, strong).

- It is a controlled trial. Method of subject allocation is not randomized. The concealment is not mentioned. The blinding is not possible.

- PFMT helped to regain continence, reduce urinary symptoms and improve quality of life after 4 weeks.

74

Bibliographic

citation

Study type

Evidence

level

Number

of

patients

Patient

characteristics

Intervention Comparison Length of

follow up

Outcome measures Effect size (95% CI), p value

Glazener et al.

(2011a)

RCT

1++

N = 442

Dropout:

45

Men with

persistent

urinary

incontinence at

6 weeks after

TURP in 34 UK

centers

Exclusion

criteria:

Men had been

received formal

PFMT, after

channel TURP,

radiotherapy.

n = 220

Lifestyle advice

leaflet and 4

individual

PFMT sessions

with a therapist

in 3 months

An PFMT

leaflet was given

for home

exercise

program

Mean age = 68.2

± 7.7 years

n = 222

Standard care to

provide lifestyle

advice leaflet

only, no PFMT.

Mean age = 67.9

± 8.1 years

Baseline, 3,

6, 9 and 12

months after

randomizatio

n

(1)Men with

incontinence

(2)ICI-Q score

(3)PFME compliance

(4)Use of aids

(5)EQ-5D

(6)SF-12 mental

(7)SF-12 physical

(8)QALYs

Other outcomes:

urinary frequency,

nocturia, urgency,

erectile dysfunction,

faecal incontinence,

constipation

(1) 1.06 (0.91 to 1.23), 0.47

(2) -0.04 (0.78 to 0.71), 0.93

(3) 3.20 (2.37 to 4.32), 0.001

(4) 0.91(0.56 to1.46), 0.68

(5) -0.01 (-0.04 to 0.03), 0.79

(6) -0.04 (-1.71 to 1.63), 0.96

(7) 0.39 (-1.22 to 1.99), 0.64

(8) -0.00003 (-0.026 to 0.026)

General comment:

The intervention increases the PFMT compliance. It does not result in better short-term or medium-term continence rate or quality of life.

75

One to one teaching of PFMT is unlikely to be effective or cost-effective compared to standard care with provision of lifestyle advice leaflet.

There were high rate of men with urinary incontinence in both intervention and control groups (64.9% and 61.6%) after 12 months. It may indicate a substantial unrecognized

complicated urinary incontinence after TURP.

Information about PFMT was freely available in the study area; there was 21% of the subjects doing PFMT after TURP before randomization.

76

Bibliographic

citation

Study type

Evidence

level

Number of

patients

Patient

characteristics

Intervention Comparison Length of

follow up

Outcome measures Effect size

Hou et al.

(2013)

RCT

1-

N = 66

Excluded:

2 with

foley

catheter on

discharge

Dropout: 3

was lost in

follow-up

Men with BPH

underwent TURP.

Inclusion criteria:

Age: 60-90 years,

remarkable LUTS,

ambulatory and

able to

communicate

verbally.

Exclusion criteria:

Discharge with

urinary catheter,

neurogenic bladder,

and dementia.

n = 32

- Perform PFMT

every day after

removal of urinary

catheter 2 days

post-operatively

- Apply EMG to

confirm correct

PFMT

- Reminded by

telephone at least

once a week

- Mean age = 69.67±

6.09 years

n = 29

- No PFMT

- Mean age =

71.41 ± 6.67

years

Before

operation

and

1, 4, 8, 12

weeks after

operation

(1)Men with

incontinence (4

weeks)

(2)IPSS (4 weeks)

- Voiding score

- Storage score

(3) Q max

(4) VV

(5) PVR

(6) SF-36 physical

(7) SF-36 mental

(1) 3vs 2 = 0 vs 0

(2) -3.01 (p <0.001)

- 0.51 (p = 0.511)

- 2.87 (p < 0.001)

(3) 4 (p = 0.026)

(4) 31.98 (p = 0.097)

(5) -7.44 (p = 0618)

(6) 5 (p = 0.029)

(7) 7.69 (p = 0.005)

General comment:

Detail method of randomization was not mentioned.

“Subject-expectancy effect” might cause some biased in this study as a complete educational program was only provided to the interventional group.

77

Bibliographic

citation

Study type

Evidence

level

Number of

patients

Patient

characteristics

Intervention Comparison Length of

follow up

Outcome measures Effect size

Ip (2004) RCT

1-

N = 16

English

speaking male

patients

undergoing

either radical

prostatectomy

(RP) or TURP.

Mean age – not

mentioned

n = 9

(TURP: 6,

RP: 3)

Information on

bladder habit

and PFMT on a

refrigerator

magnet was

given in the

pre-admission

clinic

n = 7

(TURP: 5,

RP: 2)

Information on

bladder habit

and PFMT on a

paper handout

was given in the

pre-admission

clinic

Before

operation

and telephone

survey after

operation at:

(a) 2 weeks

(b) 3 months

(1) St. George

Urinary

Incontinence

Score

(2) PFMT compliance

Magnet vs Paper (%)

(1a) 55.6 vs 42.9

(1b) 33.3 vs 28.6

(2a) 66.7 vs 57.1

(2b) 66.7 vs 85.7

General comment:

St. George Urinary Incontinence Score, 5 items with score 0 (never) – 4 (always), total score = 0-20.

The sample size is small due to the premature call-off (restructure of pre-admission clinic).

No evidence of men with magnet group with higher compliance of PFMT or continence compared to paper group.

78

Bibliographic

citation

Study type

Evidence

level

Number of

patients

Patient characteristics Intervention Comparison Length of

follow up

Outcome measures Effect size

Porru et al.

(2001a)

RCT

1+

N = 58

Dropout: 3

Men with BPH

undergoing TURP

Exclusion criteria:

Aged over 80 years

old or with urethral or

pelvic surgery,

neurogenic bladder or

prostatic cancer.

n = 28

PFMT teaching

pre-operative and

training sessions

at follow-up

(weeks 1, 2, 3, 4)

and written

instruction for

home PFMT

Mean age = 66

(53-71) years

n = 27

Not specified

Mean age =

67.5 (55-73)

years

Before

operation

and

(a) 1 week

(b) 2 week

(c) 3 week

(d) 4 week

after

TURP

(1) No. of incontinence

patient by voiding

diaries

(2) AUA Symptom Score

(3) ICS male questionnaire

(4) PFM contraction

strength

(5) Voiding interval

(6) Uroflowmetry

parameters

(1a) –8 (p < 0.01)

(1b) –11 (p < 0.01)

(1c) –8 (p < 0.01)

(1d) Not significant

(2d) Not significant

(3d) -1.7 (p < 0.001)

(4d) 1.4 (p < 0.01)

(5b) 35.5 (p < 0.01)

(5d) 8.5 (p < 0.01)

(6d) Not significant

General comment:

Significant less continence in the intervention group at 1, 2, 3 weeks, but no different at 4 weeks after operation.

PFMT helps men to regain continence earlier after TURP.

79

Bibliographic

citation

Study type

Evidence

level

Number of

patients

Patient

characteristics

Intervention Comparison Length of follow

up

Outcome measures Effect size

Tibaek, et al.

(2007)

RCT

1+

N = 58

Dropout: 9

Randomization

by grouping in

blocks of ten in a

mathematical

table

Ambulatory men

with

uncomplicated

benign prostate

obstruction who

were planned for

TURP.

Exclusion criteria:

prostate cancer,

previous lower

urinary tract

surgery,

neurological

disease.

n = 26

Start at

pre-operatively,

PFMT individual

and group lessons,

and home training

program.

Give verbal

instructions after

TURP.

Mean age:70

(58-77) years

n = 23

No

pre-operative

PFMT.

Give PFMT

knowledge

and verbal

instructions 2

to 3 days after

TURP.

Mean age: 68

(52-79) years

Before operation

and

(a) 2 weeks

(b) 4 weeks

(c) 3 months

after

operation

(1) UI (pad test

g/24 hours)

(2) PFMT

compliance

(3) DAN-PSS-1

score

(4) PFM - static

endurance

(5) PFM - dynamic

endurance

(6) Voiding

parameters

(1b) 8 (p = 0.755)

(2) 24/26 attended

all training

sessions

(3a) 2.5 (p =

0.927)

(3b) 5 (p = 0.452)

(3c) -1 (p = 0.754)

(4b) 86% vs

12.5%

improvement

(p = 0.004 vs

0.172)

(5b) 16 (p = 0.049)

(6) No significant

differences

General comment:

80

DAN-PSS-1: Danish Prostatic Symptom Scale, ranges from 0-108.

The exact duration of practicing pre-operative PFMT was not mentioned, it might affect the study result directly.

81

Appendix 4: Methodology Checklists

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Chang, P. L., Tsai, L. H., Huang, S. T., Wang, T. M., Hsieh, M. L., & Tsui, K. H.

(1998). The early effect of the pelvic floor muscle exercise after transurethral

prostatectomy. The Journal of Urology, 160, 402-405.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes.

1.2 The assignment of subjects to

treatment groups is randomised.

No. Allocated the groups by preceding

and subsequent subjects without

randomization.

1.3 An adequate concealment

method is used

No. Allocation concealment is not

mentioned.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

No. Subjects and therapists cannot be

blinded except the data entry clerical staff.

1.5 The treatment and control groups

are similar at the start of the trial.

Yes

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Yes

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

0/50 x100% = 0%

82

study dropped out before the

study was completed?

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Does not apply. All participants were

accounted for and none was lost to

follow-up at 4 weeks period.

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Does not apply. This study is carried out in

one site.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

Acceptable (+)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect is due to the study

intervention even the method of subjects

allocation is not randomised.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

Yes. High participation rate (100%, n =

50). It can be applied to the target patient

group.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

PFMT is useful in reducing urinary incontinence and terminal dribbling in 4

weeks after TURP, and provides better psychological and social quality of life.

This study should be a controlled trial

83

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Glazener, C., Boachie, C., Buckley, B., Cochran, C., Dorey, G., Grant, A., Hagen,

S., Kilonzo, M., McDonald, A., McPherson, G., Moore, K., N' Dow, J., Ramsay,

C., & Vale, L. (2011a). Conservative treatment for urinary incontinence in men

after prostate surgery (MAPS): two parallel randomized controlled trials. Health

Technology Assessment, 15(24), 1-290.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes

1.2 The assignment of subjects to

treatment groups is randomised.

Yes. Remote computer allocation.

1.3 An adequate concealment

method is used

Yes

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

No. Subjects and therapists cannot be

blinded except the data entry clerical staff.

1.5 The treatment and control groups

are similar at the start of the trial.

Yes

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Yes

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

45/442 x 100% = 10.18%

84

study was completed?

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Yes

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Yes, there is no marked difference in the

34 UK centers data reported

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

High quality (++)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect is due to the study

intervention as it demonstrates good

randomization, allocation concealment

and possible blinding techniques.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

Yes. High participation rate (86%, 442 of

512) and the large number of UK centers

contributes participants, findings can be

generalized.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

The intervention increases the PFMT compliance. It does not result in better

short-term or medium-term continence rate or quality of life.

One to one teaching of PFMT is unlikely to be effective or cost-effective

compared to standard care with provision of lifestyle advice leaflet. There are

high rate of men with urinary incontinence in both intervention and control

groups (64.9% and 61.6%) after 12 months. It may indicate a substantial

unrecognized complicated UI after TURP.

21% of the subjects doing PFMT after TURP before randomization.

Information about PFMT is freely available; it is not possible to identify a

control group that was unaware of PFM exercise.

85

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Hou, C. P., Chen, T. Y., Chang, C. C., Lin, Y. H., Chang, P. L., Chen, C. L., Hsu, Y. C.,

& Tsui, K. H. (2013). Use of the SF-36 quality of life scale to assess the effect of

pelvic floor muscle exercise on aging males who received transurethral prostate

surgery. Clinical Intervention in Ageing, 8, 667-673.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes

1.2 The assignment of subjects to

treatment groups is randomised.

Can’t say. Randomization is mentioned,

but method is not specified.

1.3 An adequate concealment

method is used.

No. Concealment method is not

mentioned.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

Cant’ say. The presence of blinding is not

mentioned. Blinding of special

technicians teaching PFMT cannot be

blind.

1.5 The treatment and control groups

are similar at the start of the trial.

Yes

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Yes

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

5/66 x100% =7.58%

86

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Yes

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Does not apply. This study is carried out in

one site.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

Acceptable (+)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect is due to the study

intervention. The methodology was not

mentioned clearly in randomization,

allocation concealment and blinding.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

Yes. The mean age and urinary

symptoms of subjects are typical

presentations of the TURP patients.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

Patients who performed PFMT for 12 weeks with closed monitoring by health

care professionals after TURP showed quicker improvement of urinary

symptoms especially in storage symptoms; and their quality of life than those

without PFMT.

87

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Ip, V. (2004). Evaluation of a patient education tool to reduce the incidence of

incontinence post-prostate surgery. Urologic Nursing, 24(5), 401-407.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes

1.2 The assignment of subjects to

treatment groups is randomised.

Can’t say. Only convenience randomized

sampling was mentioned. Allocation

method was not mentioned.

1.3 An adequate concealment

method is used.

No. Concealment method is not

mentioned.

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

No. Blinding is not possible for patients

and nurses

1.5 The treatment and control groups

are similar at the start of the trial.

Can’t say.

Only the compliance of PFMT and

incontinence score were mentioned in

baseline data.

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Can’t say. Only the numbers of patient

performing PFMT and incontinence score

were presented. No statistical

measurement was mentioned.

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

0/16 x100% = 0%

88

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Not applicable. All participants were

accounted for and none was lost to

follow-up at 3 months period.

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Not applicable. This study is carried out

in one hospital center.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

Low quality (0)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect of the study was

difficult to say as it only mentioned

randomized convenience sampling

method. The result was presented without

any statistical measurement. The major

limit of this study was the very small

sample size due to be terminated

prematurely.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

No, too small sample size.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

Inconclusive due to the study was terminated prematurely. Men in magnet

group seemed to get better incontinence score than those in paper group. A

visual reminder might be helping in adhering the PFMT.

89

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Porru, D., Campus, G., Caria, A., Madeddu, G., Cucchi, A., Rovereto, B., Scarpa,

R. M., Pill, P., & Usal, E. (2001). Impact of early pelvic floor rehabilitation after

transurethral resection of the prostate. Neurourology and Urodynamics, 20, 53-59.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes

1.2 The assignment of subjects to

treatment groups is randomised.

Can’t say. Only randomization is

mentioned, but method not specified.

1.3 An adequate concealment

method is used.

No. The concealment method is not

reported

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

Yes. A double blinding study. An urologist

performing digital evaluation of pelvic

floor muscle contraction was blinded to

the study group.

1.5 The treatment and control groups

are similar at the start of the trial.

Yes

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Yes

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

3/58 x100% = 5.17%

90

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Yes

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Does not apply. This study is carried out in

one hospital center.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

Acceptable (+)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect is due to the study

intervention as it includes random

assignment in group allocation and

blinding of the assessor. However, the

method of randomization is not provided.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

PFMT starts in pre-operative produces a quicker improvement of incontinence

state, urinary symptoms and of QOL in patients after TURP.

91

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Tibaek, S., Klarskov, P., Hansen, B. L., Thomsen, H., Andresen, H., Jensen, C. S., &

Olsen, M. N. (2007). Scandinavian Journal of Urology and Nephrology, 41, 329-334.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an

appropriate and clearly focused

question.

Yes

1.2 The assignment of subjects to

treatment groups is randomised.

Yes. Mathematical table, grouped in

blocks of ten.

1.3 An adequate concealment

method is used.

Yes. Sealed envelopes by independent

third party

1.4 Subjects and investigators are

kept ‘blind’ about treatment

allocation.

Yes. Single blinding. Independent

physiotherapist took pelvic floor

assessment before and 4 weeks after

operation. Not possible to blind the

patients and intervention physiotherapist.

1.5 The treatment and control groups

are similar at the start of the trial.

Yes

1.6 The only difference between

groups is the treatment under

investigation.

Yes

1.7 All relevant outcomes are

measured in a standard, valid and

reliable way.

Yes

1.8 What percentage of the

individuals or clusters recruited

into each treatment arm of the

study dropped out before the

study was completed?

9/58 x100% = 15.52%

92

1.9 All the subjects are analysed in

the groups to which they were

randomly allocated (often

referred to as intention to treat

analysis).

Yes

1.10 Where the study is carried out at

more than one site, results are

comparable for all sites.

Does not apply. This study is carried out in

one site.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

High quality (++)

2.2 Taking into account clinical

considerations, your evaluation

of the methodology used, and

the statistical power of the study,

are you certain that the overall

effect is due to the study

intervention?

The overall effect is due to the study

intervention as it demonstrates good

randomization, allocation concealment

and blinding techniques. A good

reliability in pelvic floor muscle

assessment and PFMT teaching by one

physiotherapist.

2.3 Are the results of this study

directly applicable to the patient

group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own

assessment of the study, and the extent to which it answers your question and

mention any areas of uncertainty raised above.

Pre-operative PFMT produced a significant improvement in pelvic floor

muscle endurance after TURP. No differences between the groups in lower

urinary tract parameters. The exact duration of providing pre-operative PFMT

was not mentioned while the control group received verbal instruction about

PFMT after 2-3 days of operation. The length of practicing PFMT before

operation is a critical factor for significant result in this study.

93

Appendix 5: Summary of Levels of Evidence

Bibliographic citation Study Type Level of Evidence

Chang, et al. (1998) Controlled trial 2 ++

Glazener et al. (2011a) RCT 1 ++

Hou et al. (2013) RCT 1-

Ip (2004) RCT 1-

Porru et al. (2001) RCT 1+

Tibaek et al. (2007) RCT 1+

94

Appendix 6: Summary of Quality Assessment of the Selected Studies

Controlled Trials Checklist

Chang, et al.

(1998)

Glazener et

al. (2011)

Hou et al.

(2013)

Ip

(2004)

Porru et al.

(2001)

Tibaek et al.

(2007)

1 The study addresses an appropriate and clearly focused question. Yes Yes Yes Yes Yes Yes

2 The assignment of subjects to treatment groups is randomised. No Yes Can’t say Can’t say Can’t say Yes

3 An adequate concealment method is used. No Yes No No No Yes

4 Subjects and investigators are kept ‘blind’ about treatment allocation. No No Can’t say No Yes Yes

5 The treatment and control groups are similar at the start of the trial. Yes Yes Yes Can’t say Yes Yes

6 The only difference between groups is the treatment under investigation. Yes Yes Yes Yes Yes Yes

7 All relevant outcomes are measured in a standard, valid and reliable way. Yes Yes Yes Can’t say Yes Yes

8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was completed?

0% 10.18% 7.58% 0% 5.17% 15.52%

9 All the subjects are analysed in the groups to which they were randomly

allocated (often referred to as intention to treat analysis).

Does not

apply

Yes Yes Does not

apply

Yes Yes

10 Where the study is carried out at more than one site, results are

comparable for all sites.

Does not

apply

Yes Does not

apply

Does not

apply

Does not

apply

Does not

apply

11 How well was the study done to minimise bias? Acceptable

(+)

High quality

(++)

Acceptable

(+)

Low quality

(0)

Acceptable

(+)

High quality

(++)

Level of evidence (SIGN, 2013) 2 ++ 1 ++ 1 - 1 - 1 + 1 +

95

Appendix 7: Summary of the Data of the Selected Intervention Studies

Bibliographic

citation

Study

design/

Evidence

level

Number of

patients/

Dropout rate

Intervention Comparison Data

collection

time

Outcome measures:

Significant difference result between intervention & comparison groups

Incidence of

incontinence

Urinary

symptoms

PFM

Strength

Quality of life

Chang, et al.

(1998)

Controlled

trial, 2++

N = 50

Dropout = 0%

n = 25

Post-op PFMT

n = 25

No PFMT

Before

operation, 1, 2,

3, 4 weeks after operation

voiding

diaries at 3, 4

weeks terminal

dribbling at 4

weeks

Voiding interval

at 2, 3, 4 weeks

× AUASS

4 weeks

Patient satisfaction

score - total, psycho &

social at 2, 3, 4 weeks

Glazener et al. (2011a)

RCT, 1++ N = 442 Dropout: 45/442

= 10.18%

n = 220 Post-op PFMT (after 6

weeks)

4 teaching sessions in 3 months

Biofeedback used in 13 men

n = 222 No PFMT

Before intervention, 3,

6, 9, 12 months

3 days voiding diaries at 3, 6, 9

12 months

× ICI-UISF

× uroflowmetry

parameters

NA PFMT

compliance

×ICIQ-UI SF

× ED-5D

× SF-12

QALYS

Hou et al. (2013)

RCT, 1- N = 66 Dropout: 5/66

= 7.58%

n = 32 Post-op PFMT

Use EMG

Phone interviews at least once/ week

n = 29 No PFMT

Before operation, 1, 4,

8, 12 weeks

after operation

× self-reporting IPSS - total & storage scores at 4

weeks

Uroflowmetry parameters: Q max

at 12 weeks

NA SF-36 physical SF-36 mental

at 12 weeks

Ip

(2004)

RCT, 1- N = 442

Dropout: 0/16 = 0%

n = 9

Pre-op PFMT Visual reminder- magnet

n = 7

Pre-op PFMT Paper reminder

Before

operation, 2, 12 weeks after

operation

× St. George

Urinary

Incontinence

Score

× IPSS NA

× PFMT

compliance

× St. George Urinary

Incontinence Score -

lifestyle

Porru et al.

(2001)

RCT, 1+ N = 58

Dropout: 3/58

=5.17%

n = 28

Pre-op PFMT, Training

sessions at 1,2,3 & 4 weeks after operation

n = 27

No PFMT

Before

operation,1, 2,

3, 4 weeks after operation

voiding

diaries at 1, 2, 3

weeks

× AUASS

voiding interval at 2 & 4 weeks

× uroflowmetry

parameters

at 4 weeks ICS- quality of life

at 4 weeks

Tibaek et al.

(2007)

RCT, 1+ N = 58

Dropout: 9/58

= 15.52%

n = 26

Pre-op PFMT

n = 23

No pre-op PFMT

Verbal instruction 2-3 days after

operation

Before

operation, 2, 4,

12 weeks after operation

× pad test × DAN-PSS-1

× voiding

parameters

at 4 weeks NA

96

Appendix 8: Recommendation from Synthesis Process

8.1 What are the suggested interventions in the PFMT regime?

PFMT starts

Measure &

grade PFM

strength

Time of

measurement

Therapists Treatment

- individual

- group

PFMT leaflet

for home

exercise

Lifestyle / Bladder

habit leaflet/

Biofeedback

Monitor the

compliance

Chang,

et al.

(1998)

Post-op

1-2 days

Pre-op

Modified

Oxford scale

Before &

weekly for 4

weeks after

TURP

Not mentioned Individual Not mentioned × PFM strength weekly

Glazener

et al.

(2011a)

Post-op

6 weeks after

Post-op

Modified

Oxford scale

Before & each

PFMT session

Physiotherapists

or continence

nurses

Individual

for 4 sessions

in 3 months

Verbal and

written

Lifestyle& bladder

training advice

leaflet

Biofeedback used in

13 men only

PFM strength in first 3

months (4 sessions)

only, then reported by

questionnaire

Hou et

al.

(2013)

Post-op

2 days × × Not mentioned Individual Not mentioned Apply EMG to

confirm correct

PFMT

Phone at least once a

week

Ip

(2004)

Pre-op

Pre-admission

clinic

× × Nurses

Not mentioned Lifestyle & bladder

habits information

Telephone survey at 2

weeks and 3 months by

senior nurses

Porru et

al.

(2001)

Pre-op

Initial visit

before surgery

Pre-op

Modified

Oxford scale

Before &

weekly for 4

weeks after

TURP

One urologist

for assessment.

Training by

physiotherapists

Individual

pre-op session

Verbal and

written

× PFM strength weekly

for 4 weeks

Tibaek et

al.

(2007)

Pre-op

Pre-op

Modified

Oxford scale

Before &

weekly for 4

weeks after

TURP

One

physiotherapists

teaching and

assessment

1 individual session

& 3 group

treatments sessions

weekly for 4 weeks,

each one hour

Verbal and

written

× PFM strength weekly

for 4 weeks

97

8.2 What is the suggested content of the PFMT regime?

PFMT content Duration Frequency/

Day

Slow/ strong

contractions

3 positions

(lying,

sitting &

standing)

Knack Tighten the PFM

strongly after

voiding urine

Bladder

training

Lifestyle

leaflet

Chang, et

al. (1998)

- 3-4 sessions of 30 exercises each daily 4 weeks 3-4 times 10 × × × × ×

Glazener

et al.

(2011a)

- Three maximum strength contractions with a

10-second break between each one.

- Target of duration of each contraction up to

maximum of 10 seconds.

12 months 2 times 3

Hou et al.

(2013)

- 5 minutes (contracts 5 seconds & relax 10

seconds) per one single PFE,

12 weeks 3 times ? × × × × ×

Ip (2004) - 5 slow contractions, relax, count for 5,

repeat 6 times in a row

12 weeks 6 times 5 × × ×

Porru et al.

(2001)

- 45 times a day and divided into 3 session of

15 contractions each

4 weeks 3 times 15 × × × × ×

Tibaek et

al. (2007)

- Strength exercise: maximum contraction

(6 seconds contraction/6 seconds rest).

- Endurance exercise:

(maximum 30 seconds contraction/ 30

seconds rest) for as long a time as possible.

- Repeat 6-10 times in the 3 positions,

4 weeks

1-2 times 6 × × ×

98

8.3 What is the frequency for follow up?

1st

week

2nd

week

3rd

week

4th

week

8th

week

12th

week

(3 months)

Others

Chang, et al. (1998)

Glazener et al. (2011a) 3, 6, 9,12 months

Hou et al. (2013)

Ip (2004)

Porru et al. (2001)

Tibaek et al. (2007)

99

Appendix 9: Summary of Recommendation from Reviewed Studies

Recommendation Grade Reviewed Studies (Level of Evidence)

Chang, et al.

(1998)

(2++)

Glazener et

al. (2011a)

(1++)

Hou et al.

(2013)

(1-)

Ip (2004)

(1-)

Porru et al.

(2001)

(1+)

Tibaek et

al. (2007)

(1+)

1. Assessment and outcome measurements

1.1 Baseline assessment on urinary incontinence and urinary symptoms

should be performed before TURP.

A

1..2 Baseline assessment on the strength of pelvic floor muscle should be

performed before TURP.

A

1.3 General health questionnaires which consist of physical,

psycho-social and emotional dimensions are suggested for assessment

the impact of quality of life related to urinary incontinence.

A

2. Pelvic floor muscle training instruction

2.1 Conduct an individual first teaching session on PFMT by trained

health care professional.

A

2.2 The strength of pelvic floor muscle contraction should be assessed and

taught by digital anal examination with verbal feedback.

A

2.3 Patients should be educated for PFMT as soon as before TURP. A

100

Recommendation (continued) Grade Reviewed Studies (Level of Evidence)

Chang, et al.

(1998)

(2++)

Glazener et

al. (2011a)

(1++)

Hou et al.

(2013)

(1-)

Ip (2004)

(1-)

Porru et al.

(2001)

(1+)

Tibaek et

al. (2007)

(1+)

2.4 Patients should practice PFMT in three positions with 1-6 times per

days and the “knack” at home.

A

3. Patient education tools

3.1 Verbal and written instructions of PFMT should be given to patients

for home practice.

A

3.2 Visual reminder acts as a reminder to practice PFMT at home. C

4. Frequency of follow-up sessions

4.1 After initial PFMT pre-operative teaching session, a reminder session

before discharge and a follow-up at 4th

week after operation are

suggested to monitor patients’ progress.

A

101

Appendix 10: ICIQ-UI Short Form

102

Appendix 11: The Chinese Version of the ICIQ-UI Short Form

103

Appendix 12:

Nurses’ Evaluation Form for Self-perceived Skills and Knowledge and

Satisfaction Levels

Dear Nurses,

Thank you for your participation in the training program: “An evidence-based

pelvic floor muscle training program to reduce urinary incontinence for patients

undergoing transurethral resection of prostate”. Please fill in your feedback below,

your opinion is valuable to us in continuously improving patient care.

Please tick in the appropriate boxes.

1 2 3 4 5

Strongly

disagree

Disagree Neutral Agree Strongly

agree

1. You understand the potential complications

of TURP.

2. You understand the benefits of pelvic floor

muscle training for TURP patients

3. You are clear the selection criteria for

target patients.

4. You are clear about the workflow of the

program.

5. The skills and measuring tools for

evaluation are well understood.

6. You have the skills to conduct the program

and make use of the measuring tools.

7. You understand the importance of

conducting the program with the support of

an evidence-based guideline.

Other comments:

____________________________________________________________________

____________________________________________________________________

Thank You.

104

Appendix 13: A Permission Letter for the use of ICIQ-UI Short Form

105

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International Consultation on Incontinence Modular Questionnaire:

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Abrams, P., Andersson, K. E., Brider, L., Brubaker, L., Cardozo, L., Chapple, C.,

Cottenden, A., Davila, W., de Ridder, D., Dmochowski, R., Drake, M., DuBeau,

C., Fry, C., Hanno, P., Hay Smith, J., Herchorn, S., Hosker, G., Kelleher, C.,

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Norton, C., Nygaard, I., Payne, C., Smith, A., Staskin, D., Tekgul, S., Thuroff, J.,

Tubaro, A., Vodusek, D. B., Wein, A., & Wyndaele, J. J. (2009). 4th

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urinary incontinence, pelvic organ prolapse and faecal incontinence. Retrieved

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Bauer, R. M., Bastian, P. J., Gozzi, C. & Stief, C. G. (2009). Postprostatectomy

incontinence: all about diagnosis and management. European Urology, 55,

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322-333.

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Chang, P. L., Tsai, L. H., Huang, S. T., Wang, T. M., Hsieh, M. L. & Tsui, K. H. (1998).

The early effect of the pelvic floor muscle exercise after transurethral

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