1

Satish SC Rao, MD, PhD, FRCP (Lon), FACG, AGAFProfessor of Medicine

Director, Neurogastroenterology/MotilityDirector, Digestive Health Clinical Research Center

Medical College of Georgia Augusta University, Augusta, GA

Common Anorectal Disorders

Disclosures

Advisory Board: Ironwood Pharmaceuticals InTone MV Synergy Pharmaceuticals Valeant Pharmaceuticals

Research Support National Institutes of Health Forest Labs/Ironwood Synergy Pharmaceuticals InTone MV

OBJECTIVES

Discuss advances in Evaluation, Diagnostic Tests & Treatment:

Dyssynergic Defecation

Fecal Incontinence

Case Study 41-yr-old school teacher

Increasing constipation- 3 yearsBegan during college daysNow, B.M once every 1-2 weeks, hard, pellet-

like stool only after Fleet’s enema + Suppository and laxatives

Uses digital maneuvers, and describes excessive straining, incomplete evacuation and occasional bleeding

Tried OTC laxatives, lubiprostone, PEG-no relief

History Contd..

Past Hx: Migraines, seasonal allergy, No back or pelvic injury, Gravida 1, para 1, No Forceps.

Drugs: Minocycline 100mg bid, Nasal spray, HFD=30g/day, Senna=2/day, PEG=34g/day,

O/E: lower abdominal fullness

What next?

3-step DRE-PROTOCOL

1) Inspection

2) Perianal sensation & anocutaneous reflex: normal, impaired, absent

3) Digital maneuvers: mass, tenderness, stool

Squeeze x 2: normal, weak, increased

Bearing down x 2 push effort, sphincter relaxation, perineal descent

Clinically dyssynergia if … any 2; • inability to

•contract abdominal muscles •relax anal sphincter

• paradoxical contraction of anal sphincter • absence of perineal descent

Tantiphlachiva K, Rao S et al, CGH 2010

2

Yield of rectal exam in dyssynergia, n=209

� All patients had � DRE

� Anorectal manometry

� Balloon Expulsion Test

� Data Analyzed independently

ParameterSensitivity

(%)Specificity

(%)

Dyssynergia from DRE 75% 87%

Balloon expulsion test 49% 90%

Tantiphlachiva K, Rao S et al, CGH 2010

Functional Subtypes:Primary Constipation

Schiller LR. Aliment Pharmacol Ther. 2001;15:749.Mertz H, et al. Am J Gastroenterol. 1999;94:609.

Slow transit and IBS-C overlap in half of each group

Evacuation Disorders59%

IrritableBowel Syndrome58%

Slow-Transit Constipation47%

•Dyssynergic Defecation

Outlet Obstr.•Rectocele•Descending perineum syndrome•Rectal prolapse

Tests of Anorectal Function

Anorectal high resolution manometry

Anal Endosonography

Rectal Compliance Test

Pudendal Nerve Terminal Latency

Balloon expulsion test

Defecography

Anal High Definition Manometry

Electromyography

Translumbar/transsacral MEP

Modified from Rao, ACG Guidelines, Am J Gastro 2004

HRM Probes

Types of Dyssynergic Defecation

Normal

Rectal

Anal

Rao et al, Neurogastroenterol Motil 2004; 16: 589

3

Grossi U, et al. Gut 2015

Defecation Index vs RA Gradient

Defecation index Recto-anal pressure gradient

45/30 = 1.50 = ND -8.5 = DD

45 mmHg

30 mmHg

43

51.5

Effect of Body Position on Defecation Patterns

Rest Bearing down

Rectal pressure

Anal pressure

Rest Bearing down

Rectal pressure

Anal pressure

Bearing Down Lying Bearing Down on Commode

Courtesy of S.Rao

Assessment of Dyssynergic Defecation

• Dyssynergia should be assessed in sitting position

• Ideally with a distended balloon in rectum• RA gradient as assessed by software is

inaccurate for dyssynergia- overestimates !• Defecation index is a better measure for

evaluating dyssynergia

Diagnostic Criteria-Dyssynergic Defecation

1. The patient must satisfy diagnostic criteria for functional constipation-Rome III

2. During repeated attempts to defecate must demonstrate Dyssynergic pattern of defecationManometry EMG

3. Patient must demonstrate one other abnormal test:a. Abnormal balloon expulsion Test (> 1 minute)b. Prolonged Colonic Transit Time (radioopaque

markers or SmartPill or Scintigraphy)c. Abnormal Defecogarphy (>50% barium

retention) Bharucha et al, Gastroenterology 2006; 130: 1514Rao SSC. Gastroenterol Clin N Am 36 (2007) 687-711

How to Treat Dyssynergic Defecation ?

General Measures Diet, exercise, fluids & habit training Laxatives/Prokinetics

Specific Treatment Botox injection Biofeedback therapy Cognitive Behavioral Therapy Surgery

Myectomy- 30% improvement Colostomy

Rao SSC. Gastroenterol Clin N Am (2008)

4

Biofeedback Therapy

A technique of conditioning and/or retraining the mind and body to normalize bowel movement.

�

How many of you perform Biofeedback ?

Biofeedback-Dyssynergia

» Goals of Therapy :• A) Teach Diaphragmatic

breathing exercise

• B) Teach anal sphincter &

pelvic floor relaxation

• C) Improve Rectal Sensation

• D) Eliminate Sensory Delay

• E) Improve Recto-anal Coordination

Post-Biofeedback-Attempted Defecation

RECTUM

ANUS

Biofeedback Therapy-RCTs

Biofeedback Vs PEG 14.6 g for Dyssynergia Chiarioni et al, Gastroenterology 2006; 130: 657-64

Biofeedback vs Diazepam for Dyssynergia Heymen et al, Dis Col Rectum 2007

Biofeedback vs Sham Therapy vs Standard Therapy Rao et al CGH 2007

Biofeedback vs Standard Therapy-One Year outcome Rao et al Am J Gastroenterol 2010

Home vs Office Biofeedback Therapy-Efficacy & Cost Effectiveness Rao et al, Go et al, DDW 2011

RCT-Biofeedback Therapy for Dyssynergian=77

Standard Treatment Biofeedback Therapy Sham Feedback

Symptom questionnaire, Stool diary, Colonic Transit, ARM, Balloon Expulsion test

Rao et al CGH 2007

Effects of Biofeedback Therapy on CSBM & Dyssynergia- ITT Analysis

Rao et al Clin Gastro Hepatol 2007

5

0

1

2

3

4

5

6

7

Biofeedback Standard

Mea

n C

SB

Ms

/ W

eek

±S

.E.

BaselineOne Year¤ §

§ p<0.0001 vs Standard

¤ p<0.0001 vs Baseline

Rao et al Am J Gastro 2010

Long Term Outcome of Biofeedback- CSBM/week

Home vs Office Biofeedback-Responder Analysis

TOST= p =0.006

Rao et al DDW 2011

CONCLUSIONS

Biofeedback Therapy

Effectively improves symptoms and anorectal function

This effect is mediated by modifying their physiologic behavior

Biofeedback therapy provides sustained improvement in bowel function

Home Biofeedback is as effective as Office Biofeedback and more cost effective

Should be the preferred treatment for patients with dyssynergia, especially when patients fail Standard Therapy

Rao et al Clin Gastro Hepatol 2011

EBM – Biofeedback Therapy

Condition Level Recommend

Dyssynergic Defecation I A

Fecal Incontinence II B

Levator Ani Syndrome II B

Solitary Rectal Ulcer Syndrome III C

Children with Functional Constipation (Encopresis)

I D

Rao SS et al, ANMS & ESNM Position paper. Neurogastro Mot 2015:

CASE STUDY

AH: 47 yrs, Gravida 3, Para 2

2005 - Fecal Incontinence - 2 months after delivery.

2012 - 2nd Delivery, symptoms have worsened. B.M. - 2/day; 4-8 incontinence episodes/wk-10yrs Senses stool coming out but cannot stop it. Flatus incontinence No urinary incontinence, back injury or diabetes. Hypothyroid Tried Psyllium, loperamide 4mg/tid-No relief

Prevalence of Fecal Incontinence: Fast Facts

Overall prevalence of fecal incontinence: 9.0%

Prevalence of fecal incontinence occurring at least once weekly:

1.1%

Prevalence in men: 7.4%

Prevalence in women: 9.1%

Prevalence in individuals aged ≥70 years: 17.5%

Prevalence of FI (≥1 time in previous month)*

Su

bje

cts

(%)

*Data from NHANES 2005/2006 and 2009/2010 surveys. N=52,195.Ditah I et al. Am J Gastroenterol. 2012;107:S717. Abstract 1762.

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Vaginal DeliverySphinc. Tear

n=365

Vaginal DeliveryNo Tearn=356

C-Sectionn=116

Odds Ratio ST vs. NT

Odds RatioNT vs. CS

FI at 6 weeks 27% 11% 10%2.8

p<0.0011.1

p=0.82

Solid & Liquid 7% 1.4% 0.9%

Liquid Only 13.7% 6.5% 4.3%

Solid Only 3.6% 2.5% 3.5%

Flatus Only 24.7% 20.2% 18.1%1.6

p=0.031.3

p=0.45

FI at 6 months 17% 8% 7.6%1.9

p<0.011.01

p=0.98

Solid & Liquid 4% 2% 1%

Liquid Only 8% 4% 4%

Solid Only 4.2% 0.3% 1%

Flatus Only 23% 18% 27%

Nygaard, et al. JAMA. 2007.

Does Vaginal Delivery Predispose to Fecal Incontinence?

Fecal Incontinence – History & Examination

Establish rapport & Overcome social stigma

Onset & Precipitating events

Duration, Severity & Timing

Coexisting problems/Surgery/Urinary Incontinence

Obstetric Hx-Forceps, Tears, Presentation, Repair

Drugs, Caffeine, Diet

Clinical Subtypes & Grading

Physical, Neurological & DRE

Rao SS. Am J Gastroenterol. 2004;99:1585-604.

Fecal Incontinence-Clinical Subtypes

Passive Incontinence Involuntary discharge of feces or flatus

without awareness

Urge IncontinenceDischarge of rectal contents in spite of

active attempts to retain

Fecal Seepage Involuntary seepage with otherwise

normal evacuation

Rao, ACG Guidelines, Am J Gastro 2004

Anal Sphincter Changes in Health & FI

Normal

HDMAUS

Incontinent

Squeeze

rest

Squeeze

rest

Squeeze

defectdefect

Nguyen M, Rao S et al, DDW 2011

Trans-lumbar & Trans-sacral MEPs

Fig. 2 Schematic of Magnetic stimulation

Tantiphlachiva K, Rao SS et al DDW 2008

Case Vignette: Incontinent vs Healthy

Healthy

Patient

LEFT RIGHT

Sacro-anal MEPs

Tantiphlachiva K, Rao SS, et al. Am J Gastroenterol. 2011.

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Trans-lumbar MEPs: Incontinence vs Controls

Tantiphlachiva K, Rao SS et al Dis Colon Rectum 2014

Rectal MEPs Anal MEPs

Pharmacological Treatment of Incontinence

Fiber Supplementation LoperamideDiphenoxylate/atropine (Lomotil®) LactuloseCholestyramine/colestipolAmitriptylineValproic acidClonidine Topical Therapy

EstrogensPhenylephrine Zinc-Aluminum

Clinical Utility of ARM in Fecal Incontinence

-Rao et al, Am J Gastro1997; 92:469-75

Cochrane Review of Medical Therapy-2013

16 trials (11 cross over), n=558

11 Trials of F.Incontinence + Diarrhea

7 tested antidiarrheals, 6 enhance anal sphincter function (Phenylephrine, valproic acid), 2 tested Lactulose, 1 zinc aluminum

Small studies, short F.up, meta-analysis not possible

Risk of bias unclear

Conclusions:

Focus of most therapy was diarrhea not incontinence

Little evidence to guide clinicians, Larger well designed trials are required

Omar et al , Cochrane data base systematic rev 2013

Goals of Neuromuscular Training for Fecal Incontinence

Rao, ACG Guidelines. Am J Gastro. 2004.

Biofeedback Therapy

Strengthen anal sphincter/Puborectalis muscleEndurance + Strength

Improve rectal sensation/sensory delay

Rectoanal coordination training Isolation of anal muscles

Control of Accessory Muscles

Training to correct dyssynergia & evacuation

Biofeedback vs Non-digital assisted squeezes-Incontinence: Primary Outcome

* P < 0.001

**

Heymen S, Whitehead W et al, DDW 2007

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Responder Analysis, Home vs Office Biofeedback

P=1.000

Xiang X, Sharma A, Rao SS. ACG 2017

Surgical Treatment of Incontinence

Sphincteroplasty

Rectal Augmentation

SECCA procedure

Sacral nerve stimulation

Maloney-ACE procedure

Colostomy

Rao, ACG Guidelines, Am J Gastro 2004

Long Term Data

Glasgow, Lowry DCR 2012

SPHINCTEROPLASTY long term results

Sacral Nerve Stimulation for Incontinence

4-6 needles,bilaterally, S2-S4, Temporary –14 days, later Permanent

Rao SS, Am J Gastroenterol 2004; 99:1585-604

Sacral Nerve Stimulation System: Bowel Control Study

Wexner SD, Coller JA et al. Ann Surg. 2010;251:441-449.

Per

cen

t o

f P

atie

nts

3 Months(n=113)

6 Months(n=107)

12 Months(n=106)

24 Months(n=67)

36 Months(n=30)

Follow-up Interval

Improvement in Weekly Incontinent Episodes

Significantly higher responder rates in Solesta group at 6 months (Responder50)

53.2%

30.7%

0

20

40

60

80

Solesta Sham

Proportion responders 5

0(%

)   

D p ‐value = 0.004D p ‐value = 0.004

All 3 pre‐specified success criteria at 6 and 12 months were 

met

Graf et al, Lancet 2011; 377: 997–1003

Efficacy of Dextranomer (Solesta®) in F.Incontinence, RCT

9

Mellgren A et al, NGM 2014

Long Term Efficacy of NASHA

New devices for Fecal Incontinence

Role of anal/vaginal plugs & Devices: Fenix®, Renew®, Vaginal insert (Pelvalon®)

EBM – Incontinence – 2017

Treatment Modality Level RecommendationPharmacological

Loperamide II BDiphenoxylate/atropine II BLactulose II C

Fiber supplements II BClonidine II C

Topical TherapyZinc Aluminum II BEstrogen II BPhenylephrine I C

Biofeedback Therapy I ASNS II BTENS/PTNS I CDextranomer (NASHA Dx) I A

Take Home Points

Detailed History, Physical & DRE important Dyssynergic defecation is common but HRM and

HDM are sensitive and should be used appropriately for accurate diagnosis

Fecal incontinence is multifactorial ARM, Anal Ultrasound, MRI, Neurophysiology

Tests are complementary Life style measures, antidiarrheals are helpful

Therapeutic options will depend on a clear understanding of pathophysiology

Biofeedback should be preferred option Selected cases surgery or SNS or Dextranomer