e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4

Evaluation of Quality of Life and Quality of Sleepin Clinical Practice

Emmanuel Chartier-Kastler a,*, Kate Davidson b

aDepartment of Urology, Hospital Pitie-Salpetriere, University Paris VI, Paris, FrancebCentre for Research on Ageing and Gender, Department of Sociology, University of Surrey, Guildford, UK

avai lable at www.sc iencedi rect .com

journal homepage: www.europeanurology.com

Article info

Keywords:Benign prostatic hyperplasiaEnergyFatigueLower urinary tractsymptomsNocturiaQuality of lifeQuality of sleepQuestionnaireVitality

Please visitwww.eu-acme.org/europeanurology to read andanswer questions on-line.The EU-ACME credits willthen be attributedautomatically.

Abstract

Nocturia has been recognised as one of the most bothersome storagesymptoms in patients with lower urinary tract symptoms suggestive ofbenign prostatic hyperplasia (LUTS/BPH). It has a negative impact onquality of sleep (QoS), which might result in daytime fatigue, decreasedenergy/vitality, insomnia, and increased incidence of infection, and mayultimately negatively affect the patient’s quality of life (QoL). However,the evaluation of a patient with LUTS/BPH and assessment of benefits ofnew medical and surgical LUTS/BPH treatments are mainly focused onvoiding symptoms or flow rate. The impact of storage symptoms, inparticular nocturia, on the patient’s QoS and QoL is often underesti-mated. Commonly used instruments to measure the severity of nocturiaand its impact on QoS and QoL are not specific and lack sensitivity.Potential new instruments that evaluate the consequences of nocturiaon QoL are nocturia-specific questionnaires such as the Nocturia QoL(N-QoL) questionnaire. Furthermore, the assessment of ‘‘Hours of Undis-turbed Sleep’’ (HUS) seems a useful method to evaluate the impact ofnocturia on QoS. These new tools should be incorporated in clinicalpractice and may give better insights into the effects of LUTS/BPHtreatments on the patient’s QoS, energy/vitality, and overall QoL.# 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.

* Corresponding author. Department of Urology, Hospital Pitie-Salpetriere, University Paris VI,Boulevard de l’Hopital 83, 75013 Paris, France. Tel. +33 (1) 42177129; Fax: +33 (1) 42177160.E-mail address: emmanuel.chartier-kastler@psl.aphp.fr (E. Chartier-Kastler).

1. Introduction

Nocturia, defined as the complaint that the indivi-dual has to wake at night one or more times to void[1], is one of the most bothersome lower urinarytract symptoms suggestive of benign prostatichyperplasia (LUTS/BPH) [2]. A recent study reportedthat nocturia is the most prevalent LUTS among

1569-9056/$ – see front matter # 2007 European Association of Urology. Publis

men in five different countries [3]. Moreover,another recent and interesting paper found thatnocturia is a significant independent predictor ofmortality among 70-year-old patients with knowncoronary heart disease and thus warrants specialattention [4]. The bothersomeness of nocturia islargely due to the fact that it interferes with thequality of sleep (QoS), which may have a significant

hed by Elsevier B.V. All rights reserved. doi:10.1016/j.eursup.2007.01.006

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4 577

negative impact on how the patient feels the nextday. Disturbed sleep reduces the patient’s vitalityand concentration, negatively affects his mood, andultimately impairs the patient’s overall quality of life(QoL). Sleep deprivation also increases the patient’srisk of accidents at work, on the road, and at home.Disturbed sleep due to nocturia may even lead toincreased long-term morbidity and mortality [5].Furthermore, sleep deprivation has also beenassociated with reduced natural immune responsesand cytokine levels in the blood, resulting in anincreased risk of infections [6]. Another reason forconcern is that nocturia might not only affect theQoS and QoL of the patients, but also their partnerssuffer from lack of sleep [7].

Bearing in mind the negative impact of chronicsleep deprivation due to nocturia, urologists shouldpay more attention to the evaluation of nocturia inboth clinical practice and clinical research. In theinitial evaluation of patients with LUTS/BPH suffer-ing from nocturia, it is important to distinguishbetween polyuria and nocturia. This can be done bymeans of a 24-h voiding diary [8–10]. A clinicalevaluation is mandatory to determine the under-lying cause of nocturia [10]. While very littleresearch has focused exclusively on nocturia andits impact on a patient’s QoS and QoL, a considerableamount of research has been published on theprevalence of LUTS and its treatment outcomes [11].The symptom of nocturia has been included inseveral questionnaires designed to assess the pres-ence of LUTS. In most of these questionnaires,nocturia is included as one of several items that areadded together to form a score, and as a conse-quence, the prevalence and severity of nocturia aredifficult to investigate. Specific, sensitive, andvalidated questionnaires, measuring the impact of

Fig. 1 – Schematic representation of th

LUTS/BPH on QoL, have recently been developedinvestigating the severity of nocturia and its impacton QoS and QoL. In this review, various instrumentsmeasuring the impact of LUTS/BPH, and morespecifically nocturia, on patient’s QoS and QoL arebeing discussed. In addition, the evaluation ofvitality/energy and QoL of patients with chronicconditions not associated with nocturia will bediscussed.

2. Evaluation of energy/vitality andquality of life

The term QoL is widely used in clinical studies, oftenwithout a clear definition. It is commonly linked tothe World Health Organization’s definition of health,which refers to a state of physical, emotional, andsocial well-being, and not just the absence of diseaseor infirmity [12]. The term QoL has superseded theconcept of ‘‘well-being,’’ and serious attempts havebeen made to understand and define its meaning:How people subjectively report their perceived QoL,and how we might more objectively measure it [13].Self-reported QoL levels are typically quite high, butsometimes this finding depends on how and in whatorder the questions are asked. There is consensusthat QoL is a multidimensional concept and that thedimensions can be grouped under the broad head-ings of physical, functional, psychological, andsocial health (Fig. 1) [14]. Important concepts suchas energy/vitality, pain, depression, and othercognitive functions are included within thesebroader headings.

Blane et al [15] developed a self-completionmeasure of QoL, CASP-19, covering certain needsthat are common to all humans. These include

e definition of quality of life [14].

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4578

control (the ability to act freely in one’s environ-ment), autonomy (the need to be free from undueinterference from others), self-realisation (self-esteem), and pleasure (the need to enjoy oneself).They found that each of the domains exhibited goodinternal consistency, correlated well with eachother, and loaded well on a latent factor. The overallscale also correlates well with the Life SatisfactionIndex–Well being (LSI-W). This clearly emphasizesthat QoL is not just about health status, but is alsomediated by life course trajectories such as socio-economic status, health status, marital status,personality, gender, and age.

Since improvement of QoL is an important endpoint in the management of LUTS/BPH, it is essentialto be able to measure the QoL of patients. Instru-ments to measure the QoL are being increasinglyused in a wide variety of patients and in manydifferent studies. This increased use has led to therealisation that clinicians’ and patients’ judgementsregarding QoL and the effects of clinical interventiondiffer considerably, which has increased recognitionof the patients’ view when evaluating new inter-ventions in the management of LUTS. However,there is still a lack of conformity in the use ofoutcome measures in both the clinical and researchsettings [16]. Aspects of QoL can be explored throughthe use of in-depth interviews or questionnaires[11]. Interviews with individuals can providedetailed information about perceptions of healthand illness, and specific issues relating to the impactof symptoms on a person’s everyday life. However,interviews are time-consuming, and the mostcommon method of assessing some aspects ofQoL is through questionnaires. Questionnaires tomeasure the QoL can be broadly classified into twomajor categories: generic questionnaires designedto measure the multidimensional nature of healthstatus and suitable for a broad range of illnesses andpopulations, and disease-specific questionnairesdesigned to measure the specific impact of aparticular disease (eg, LUTS/BPH) on QoL. Beforethey can be used, questionnaires need to be testedfor validity, reliability, and sensitivity.

Generic instruments to measure the QoL ofpatients include the Sickness Impact Profile (SIP)[17], the Nottingham Health Profile (NHP) [18], theEuroQol (EQ-5D) index [19], and the Short Form (SF)-36 health survey questionnaire [20,21]. The SF-36 is a36-item, short-form version of a questionnaire andis scored in eight subscales: physical functioning,role-physical, bodily pain, general health percep-tions, energy/vitality, social functioning, role-emo-tional, and mental health. It is probably the mostpopular generic instrument to measure the mental

health and general health components of QoL. Somestudies use only one or more subscales of the SF-36survey. The vitality subscale can be used to evaluatethe energy level and fatigue. This subscale consistsof four items, each rated on a six-point Likert scale.Two items are worded positively (‘‘Did you feel fullof pep’’; ‘‘Did you have a lot of energy’’), and twoitems are worded negatively (‘‘Did you feel wornout’’; ‘‘Did you feel tired’’). Scores range from 0–100,with higher scores reflecting less fatigue andmore energy [20,21]. The SF-36 instrument is ideallyused in combination with disease-specific ques-tionnaires. The SF-12 was developed as a muchshorter, yet validated, alternative to the SF-36 [22].Instruments such as the NHP and the SF-36 are‘‘health-profile’’ measures because they compriseseveral different domains, each of which has its ownscore. This means that health-profile measuresprovide a detailed perspective of the patient butdo not generally determine how important a givenproblem is. The EQ-5D is an ‘‘index’’ measure andquestions are added together to achieve a singlescore. Index measures provide information aboutthe relative value of various health states but fail toreflect specific problems that might emerge [14].Nevertheless, all these questionnaires lack a suffi-cient degree of sensitivity to evaluate changes in apatient’s clinical condition.

The Functional Assessment of Chronic FatigueIllness Therapy (FACIT) scale is a collection ofhealth-related QoL questionnaires targeted to themanagement of patients suffering from chronicdiseases, including cancer, multiple sclerosis andarthritis [23–26]. The FACIT scale is a 27-itemcompilation of general questions divided intofour primary QoL domains: physical well-being,social/family well-being, emotional well-being,and functional well-being. The FACIT fatigue sub-scale (FACIT-F) is a 13-item questionnaire specifi-cally measuring fatigue in patients with chronicillnesses [23]. Items included in this FACIT-F scaleinclude ‘‘I feel fatigued’’, ‘‘I have energy’’, and‘‘I need to sleep during the day’’. Each item rangesfrom 0 (not at all) to 4 (very much) and the total scoreranges from 0–52, with a higher score indicatingmore fatigue.

3. Impact of chronic conditions on vitalityand energy

Chronic conditions, such as neuropathic pain,diabetes, and rheumatoid arthritis impair patient’senergy and vitality. This problem is clearly recog-nised in clinical practice. Various patient-reported

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4 579

measures, such as the EQ-5D, the vitality scale of theSF-36, and the FACIT-F scale are used to evaluatethe patient’s condition, as well as the impact oftreatment on health-related outcomes. Patientswith chronic conditions often score around 40–60on the vitality scale of the SF-36 [27–29]. Appropriatetreatment should improve the patient’s condition.The minimally important difference (MID) is definedas the smallest change in score that a patient wouldperceive as beneficial. MIDs should be roughly 3–5for the SF-36 questionnaire, 3–4 for the FACIT-Fscale, and 0.07 for the EQ-5D [25,30,31]. Severalstudies demonstrate that treatment of patients withchronic pain significantly improves the vitalitysubscale of the SF-36 [32,33]. In a randomisedcontrolled trial including 549 patients with type 2diabetes, 26 weeks of treatment with twice-dailyexenatide or once-daily insulin glargine signifi-cantly improved the vitality score of the SF-36(Fig. 2) [34]. A double-blind, placebo-controlledrandomised trial in 618 patients with moderate tosevere psoriasis treated with placebo or 50 mg twice-weekly etanercept showed a significant and clini-cally meaningful improvement in fatigue in patientson etanercept (mean FACIT-F improvement: 5.0 vs.1.9; p < 0.0001). The improvements in fatigue werecorrelated with decreases in joint pain [35].

The data above clearly show that several chronicdiseases cause a major burden on patients QoL.Chronic conditions may cause fatigue, and reducethe patient’s energy and vitality and ultimatelyoverall QoL. It is important to recognise this problemin daily clinical practice. Appropriate treatment ofthe problem does not only relieve the symptoms, butis often associated with relief of disease-relatedproblems such as fatigue, loss of energy, and

Fig. 2 – In a randomised controlled trial including patients

with type 2 diabetes, treatment with exenatide and

insulin glargine significantly improved the vitality score of

the SF-36 compared with baseline [34]. SF-36 = Short

Form-36 health survey questionnaire.

impairment of overall QoL. Even if treatments donot cure or prevent the disease, amelioration ofunpleasant side-effects, such as loss of energy(eg, due to nocturia) compounded with difficultyin getting back to sleep, may well improve perceivedQoL. The QoS of partners disturbed by men at nightmay also improve, as may their levels of anxiety andsubsequently their relationship [36].

4. Evaluation of quality of sleep

It has been demonstrated that sleep is vital forphysical and mental functioning. Lack of sleep isassociated with daytime fatigue, impaired cognitivefunctioning, mood disturbances, increased rates ofinfections, depression, and impaired productivity atwork. Furthermore, lack of sleep has been found tobe predictive of traffic and occupational accidents,and has deleterious consequences on body systems.Moreover, it has been implicated in decreasedimmune functioning and increased risk of cardio-vascular disease and diabetes [5]. This indicates thatsleep disorders have negative consequences forhealth, functioning, and overall QoL, especially inelderly people. Therefore, it will be important toimprove QoS, which may improve the patient’senergy/vitality levels and daytime QoL.

Sleep quality represents a complex phenomenonthat is difficult to define and measure objectively. Itincludes quantitative aspects of sleep, such as sleepduration and sleep latency as well as more sub-jective aspects such as depth or restfulness of sleep.Polysomnography provides accurate information onthe physiologic indices of QoS. However, it isexpensive, and it requires much time for testingand interpretation of data. Actigraphy is anothermethod for objective sleep monitoring that mea-sures sleep activity around the clock. Alternatively,self-reported methods such as sleep diaries, sleeplogs, and sleep questionnaires provide a measure-ment of QoS experienced by the patient. Thesesubjective methods attempt to measure both quan-titative as well as qualitative aspects of sleep and areeasily administered, inexpensive, and have a wideapplicability [37]. However, it should be noted thatmethods applying questionnaires remain subjec-tive, since they require a variable time period spentby the patients, so subjective performance varia-bility of the individuals completing the tests has tobe considered, especially when confronted withcomplex and extended tests.

Several questionnaires have been developed tomeasure QoS. The Epworth Sleepiness Scale (ESS)[38] is a questionnaire designed to measure daytime

Fig. 3 – The mean vitality score (SF-36 quality of life score)

is lower for patients with severe LUTS (IPSS 20–35) than for

patients with other chronic diseases. (Adapted from

reference 45.) The lower the score, the poorer the health.

SF-36 = Short Form-36 health survey questionnaire;

LUTS = lower urinary tract symptoms; IPSS 20–35 =

International Prostate Symptom Score questions 20–35.

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4580

sleepiness in a simple and standardized way. TheSleep Disorders Questionnaire (SDQ) [39] consists of175 items, and its usefulness in patients with sleepdisorders has been confirmed. On the other hand,the Leeds Sleep Evaluation Questionnaire (LSEQ) [40]contains 10 questions concerned with aspects ofsleep and early morning behaviour. Furthermore, ina Dutch adult population, sleep problems, such assleep onset, midsleep awakening, early morningawakening, and daytime sleepiness, were measuredusing the Sleep Wake Experience List (SWEL) [41,42].Another instrument of subjective sleep complaintsis the Basic Nordic Sleep Questionnaire (BNSQ) [43],which has been widely used in a variety of studiesperformed in Nordic countries. Its main differencecompared with many of the previous questionnairesis the five-point quantitative scale evaluating howmany nights/days per week a problem occurs.

Although many questionnaires can be used tomeasure QoS, they share several limitations. Forinstance, only a very few of them have used timeintervals for assessment. In contrast, the PittsburghSleep Quality Index (PSQI) [44] has been widely usedto measure QoS and disturbances over a 1-mo timeinterval, which is clinically and scientifically useful.It is scored in seven domains: subjective QoS, sleeplatency, sleep duration, sleep efficiency, sleepdisturbance, use of sleep medicine, and daytimedysfunction. The recently developed Sleep QualityScale (SQS) [37] is a valid and reliable instrumentdeveloped to measure QoS of adults. It is scored insix domains: daytime dysfunction, restoration aftersleep, difficulty in falling asleep, difficulty in gettingup, satisfaction with sleep, and difficulty in main-taining sleep. Compared with the PSQI, the SQSincludes more items about restorative functionsafter sleep, difficulty in getting up, and variousdaytime dysfunctions due to poor sleep. However,all these measurements were not specificallydesigned to assess the impact of a disease-specificcondition on QoS.

5. Measuring the impact of LUTS/BPH onquality of life

Many studies have examined the impact of LUTS/BPH and have shown them to be deleterious on dailylife activities and QoL. Symptoms causing the mostbother include those associated with urgency, day-time frequency, nocturia, and incontinence. Treat-ment of patients with chronic illnesses primarilyaims to make patients feel better and improve theirQoL. When compared with patients suffering fromLUTS/BPH (International Prostate Symptom Score

[IPSS] 20–35), men with other chronic illnesses suchas diabetes, angina, hypertension, and gout havemore energy/vitality, as measured by the SF-36 QoLquestionnaire (Fig. 3) [45]. The authors concludedfrom this study that men with severe LUTS have apoorer health status in several important QoLdimensions. Although the SIP, the NHP, and theSF-36 are established, reliable, and valid genericmeasures, which allow comparisons with otherdiseases, they are not sensitive enough to measurethe impact of a specific disease such as LUTS/BPH onpatient’s QoL. As a consequence, disease-specificquestionnaires were developed. However, combina-tions of generic measures with disease-specificmeasures are recommended to measure the impactof a condition on QoL.

The BPH Impact Index [46] measures how muchthe urinary problems affect various domains ofhealth. The BPH Health Related Quality of Life (BPH-HRQOL) questionnaire [47] was designed to explorephysical, mental, social, and general aspects of QoL.This questionnaire combines disease-specific andgeneric aspects of QoL. Furthermore, the IPSSincludes one single question that aims to evaluatethe impact of the present urinary condition on QoL[48]. A questionnaire that assesses the impact ofseveral urinary symptoms on QoL is the SymptomProblem Index (SPI) [46]. In the Veterans AffairsQuestionnaire [49], the symptoms most stronglyassociated with changes in QoL were storagesymptoms such as nocturia, frequency, andurgency. The International Continence SocietyQuality of Life (ICSQoL) questionnaire [50] has also

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4 581

shown a strong relationship between nocturia andthe general question about interference with life.Other questionnaires that measure the impact ofLUTS/BPH on QoL include the BPH survey [51] andthe Olmstead County Index [52]. However, thesequestionnaires do not look specifically at the impactof one bothersome symptom (such as nocturia) butrather at the impact of urinary symptoms in generalon QoL and activities of daily living.

Table 1 – Quality of life measures in LUTS/BPH andnocturia: generic and disease-specific questionnaires toassess the impact of LUTS, including nocturia onpatient’s quality of life

Genericquestionnaires

Disease-specificquestionnaires

SIP LUTS/BPH-specific

NHP BPH Impact Index

EuroQoL Index BPH-HRQoL

SF-36 IPSS

SPI

Veterans Affairs Questionnaire

ICSQoL

BPH survey

Olmstead County Index

Nocturia-specific

N-QoL

ICIQ-N

SIP = Sickness Impact Profile; NHP = Nottingham Health Profile;

SF-36 = Short Form-36 health survey questionnaire; LUTS/

BPH = lower urinary tract symptoms suggestive of benign

prostatic hyperplasia; BPH-HRQoL = BPH Health Related Quality

of Life; IPSS = International Prostate Symptom Score; ICSQoL =

International Continence Society Quality of Life; N-QoL =

Nocturia Quality of Life; ICIQ-N = International Consultation on

Incontinence Questionnaire-Nocturia.

6. Measuring the impact of nocturia onquality of sleep and quality of life

In the field of LUTS/BPH, no clinical studies to datehave evaluated the bothersomeness of nocturia, andthere is even less information on the impact ofnocturia on QoL. This lack of information is due tothe fact that commonly used measurements are notsensitive enough. The Danish Prostatic SymptomScore (DAN-PSS) was designed to measure QoLassociated with voiding problems and the degreeto which patients are bothered by their urinarysymptoms [53,54]. Questions about the frequencyand bothersomeness of nocturia are included, butthis questionnaire is not designed nor evaluated formeasuring the impact of nocturia on QoL.

A large majority of experts participating in thediscussion forum at the 6th International Consulta-tion on New Developments in Prostate Cancer andProstate Diseases (Paris, France, 24 June, 2005)agreed that sleep disturbance due to nocturia isthe dominant factor affecting QoL in patients withLUTS/BPH [55]. However, no questionnaires specifi-cally measured the impact of nocturia on QoS.Recently, a specific Nocturia Quality of Life ques-tionnaire (N-QoL) has been developed and validatedto measure the impact of nocturia on QoS and QoL[56]. This 13-item questionnaire consists of threedomains, a sleep/energy domain, a bother/concerndomain, and a global QoL question, and takes about5 min to complete. It deals with daytime energy,worry, productivity, sleep, and vitality. The N-QoLscores correlate with the energy/vitality and socialfunctioning domains of the SF-36 [20] and with thesleep quality domain of the PSQI [44]. Anotherquestionnaire to measure the impact of nocturia onQoL is the International Consultation on Incon-tinence Questionnaire-Nocturia (ICIQ-N), which iscurrently under development [57]. The N-QoL hasbecome one of the modules for this questionnaire.Preliminary results show that the ICIQ-N has goodlevels of reliability and validity. Moreover, Cai et al[58] have recently used the N-QoL questionnaire toevaluate the impact of surgical treatment on

nocturia and QoL in men with LUTS related tobenign prostatic obstruction. They showed thatsurgical intervention leads to a decrease in thenocturia rate and an increase in QoL. Along theselines, a new questionnaire has been developed andvalidated to measure the severity and impact ofnocturia, nocturnal enuresis, and sleep interrup-tions in an elderly population of men and woman inDenmark [59]. This Nocturia, Nocturnal Enuresisand Sleep-interruption Questionnaire (NNES-Q) mayalso have a potential in clinical settings, since it isbrief and provides the level and impact of nocturia,nocturnal enuresis, and sleep interruptions on QoL.An overview of the quality of life measures in LUTS/BPH and nocturia is given in Table 1.

Nevertheless, the QoS may not only depend onthe frequency of nocturnal voids, but also on thetime from falling asleep to the first awakening tovoid. This period, defined as the Hours of Undis-turbed Sleep (HUS), should be at least 3–4 h and mayprovide a useful method to measure the impact ofnocturia on QoS [60]. The best way to measure HUSis yet to be determined. The easiest and lessexpensive instrument is a sleep diary/log, but itsoutcomes may be less reliable because of recall bias.Although the most accurate method can only beapplied in a sleep laboratory, devices such as theactigraph can be used as an alternative to measurethe HUS in patients with LUTS/BPH [61]. Advantages

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4582

of actigraphy include its ease of use, its low costand noninvasive nature, and its automated sleepscoring and data storage. A relatively new method toassess wakefulness, rapid eye movement (REM)sleep and non-REM sleep, is the REM view [62],but it requires additional testing to show that thisdevice outperforms other available sleep assess-ment methods.

7. Conclusions

Patients with chronic diseases are likely to sufferfrom lack of energy and vitality, and as a conse-quence have decreased QoL. It is clear that this is animportant problem in many disease areas. Similar toother chronic conditions, urologists should be awareof the problem of nocturia and its consequences. Inlight of the significant negative impact of bother-some urinary symptoms such as nocturia on thepatient’s QoS and his daytime energy/vitality andQoL, the severity of nocturia should be evaluated inclinical practice. Urologists should routinely askpatients with LUTS/BPH about nocturia-relatedproblems, such as disturbed sleep, lack of energy,and impairment of QoL. Treatments for men withLUTS/BPH should be evaluated for their ability torelieve nocturia. However, measuring the severity ofnocturia and its impact on QoS and QoL remains anobstacle. Most instruments currently used formeasuring the impact of nocturia on the QoL andenergy/vitality of patients lack sensitivity and arenot specific. Therefore, new instruments need to beincluded in clinical research such as the recentlydeveloped and validated N-QoL questionnaire. Inaddition, the assessment of HUS was suggested as apotential instrument to measure the influence ofnocturia on the QoS. Furthermore, new simple andvalid instruments should be developed for use indaily clinical practice.

References

[1] Abrams P, Cardozo L, Fall M, et al. The standardisation of

terminology in lower urinary tract function: report from

the standardisation sub-committee of the International

Continence Society. Urology 2003;61:37–49.

[2] Jolleys JV, Donovan JL, Nanchahal K, et al. Urinary symp-

toms in the community: how bothersome are they? Br J

Urol 1994;74:551–5.

[3] Irwin DE, Milsom I, Hunskaar S, et al. Population-based

survey of urinary incontinence, overactive bladder, and

other lower urinary tract symptoms in five countries:

results of the EPIC study. Eur Urol 2006;50:1306–15.

[4] Bursztyn M, Jacob J, Stessman J. Usefulness of nocturia as

a mortality risk factor for coronary heart disease among

persons born in 1920 or 1921. Am J Cardiol 2006;98:1311–5.

[5] Asplund R. Nocturia: consequences for sleep and daytime

activities and associated risks. Eur Urol Suppl 2005;3(6):

24–32.

[6] Irwin M, McClintick J, Costlow C, et al. Partial night sleep

deprivation reduces natural killer and cellular immune

responses in humans. FASEB J 1996;10:643–53.

[7] Mitropoulos D, Anastasiou I, Giannopoulou C, et al. Symp-

tomatic benign prostate hyperplasia: impact on partners’

quality of life. Eur Urol 2002;41:240–5.

[8] Weiss JP, Blaivas JG. Nocturia. J Urol 2000;163:5–12.

[9] Marinkovic SP, Gillen LM, Stanton SL. Managing nocturia.

BMJ 2004;328:1063–6.

[10] Marschall-Kehrel D. Update on nocturia: the best of rest is

sleep. Urology 2004;64(Suppl 6A):21–4.

[11] Donovan JL. Measuring the impact of nocturia on quality

of life. BJU Int 1999;84(Suppl 1):21–5.

[12] World Health Organisation. The constitution of the WHO.

WHO Chronicle 1947;1:29.

[13] Gilhooly M, Gilhooly K, Bowling A. Quality of life: meaning

and measurement. In: Walker A, editor. Understanding

quality of life in old age. Buckingham: Open University

Press; 2005.

[14] MacDonagh R. Quality of life and its assessment in urol-

ogy. Br J Urol 1996;78:485–96.

[15] Blane D, Wiggins R, Higgs P, et al. Inequalities in quality of

life in early old age. GO findings 9, Sheffield: Growing

Older Programme. Sheffield (UK): University of Sheffield;

2002.

[16] Robinson D, Anders K, Cardozo L, et al. Outcome mea-

sures in urogynaecology: the clinicians’ perspective. Int

Urogynecol J Pelvic Floor Dysfunct 2006. In press.

[17] Hunskaar S, Vinsnes A. The quality of life in women with

urinary incontinence as measured by the sickness impact

profile. J Am Geriatr Soc 1991;39:378–82.

[18] Grimby A, Milsom I, Molander U, et al. The influence of

urinary incontinence on the quality of life of elderly

women. Age Ageing 1993;22:82–9.

[19] EuroQol—a new facility for the measurement of health-

related quality of life. The EuroQol Group. Health Policy

1990;16:199–208.

[20] Brazier JE, Harper R, Jones NM, et al. Validating the SF-36

health survey questionnaire: new outcome measure for

primary care [see comments]. BMJ 1992;305:160–4.

[21] Ware Jr JE, Sherbourne CD. The MOS 36-Item Short-Form

Health Survey (SF-36). I. Conceptual framework and item

selection. Med Care 1992;30:473–83.

[22] Ware Jr J, Kosinski M, Keller SD. A 12-Item Short-Form

Health Survey: construction of scales and preliminary

tests of reliability and validity. Med Care 1996;34:220–33.

[23] Cella D, Yount S, Sorensen M, et al. Validation of the

Functional Assessment of Chronic Illness Therapy Fati-

gue Scale relative to other instrumentation in patients

with rheumatoid arthritis. J Rheumatol 2005;32:811–9.

[24] Cella D, Lai JS, Chang CH, et al. Fatigue in cancer patients

compared with fatigue in the general United States popu-

lation. Cancer 2002;94:528–38.

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4 583

[25] Cella D, Eton DT, Lai JS, et al. Combining anchor and

distribution-based methods to derive minimal clinically

important differences on the Functional Assessment of

Cancer Therapy (FACT) anemia and fatigue scales. J Pain

Symptom Manage 2002;24:547–61.

[26] Yellen SB, Cella DF, Webster K, et al. Measuring fatigue

and other anemia-related symptoms with the Functional

Assessment of Cancer Therapy (FACT) measurement sys-

tem. J Pain Symptom Manage 1997;13:63–74.

[27] Ibrahim IA, Beich J, Sidorov J, et al. Measuring outcomes of

type 2 diabetes disease management program in an HMO

setting. South Med J 2002;95:78–87.

[28] Reza M, Taylor CD, Towse K, et al. Insulin improves well-

being for selected elderly type 2 diabetic subjects. Dia-

betes Res Clin Pract 2002;55:201–7.

[29] Aggarwal A, Chandran S, Misra R. Physical, psychosocial

and economic impact of rheumatoid arthritis: a pilot

study of patients seen at a tertiary care referral center.

Natl Med J India 2006;19:187–91.

[30] Hays RD, Morales LS. The RAND-36 measure of health-

related quality of life. Ann Med 2001;33:350–7.

[31] Walters SJ, Brazier JE. Comparison of the minimally

important difference for two health state utility mea-

sures: EQ-5D and SF-6D. Qual Life Res 2005;14:1523–32.

[32] Pace MC, Passavanti MB, Grella E, et al. Buprenorphine in

long-term control of chronic pain in cancer patients.

Front Biosci 2007;12:1291–9.

[33] Otto M, Bach FW, Jensen TS, et al. Health-related quality of

life and its predictive role for analgesic effect in patients

with painful polyneuropathy. Eur J Pain 2006. In press.

[34] Secnik BK, Matza LS, Oglesby A, et al. Patient-reported

outcomes in a trial of exenatide and insulin glargine for

the treatment of type 2 diabetes. Health Qual Life Out-

comes 2006;4:80.

[35] Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical

outcomes, fatigue, and depression in psoriasis: double-

blind placebo-controlled randomised phase III trial. Lan-

cet 2006;367:29–35.

[36] Hislop J, Arber S. Understanding women’s sleep manage-

ment: beyond medicalisation-healthisation? Sociol

Health Illn 2003;25:815–37.

[37] Yi H, Shin K, Shin C. Development of the sleep quality

scale. J Sleep Res 2006;15:309–16.

[38] Johns MW. A new method for measuring daytime sleepi-

ness: the Epworth sleepiness scale. Sleep 1991;14:540–5.

[39] Douglass AB, Bornstein R, Nino-Murcia G, et al. The Sleep

Disorders Questionnaire. I: Creation and multivariate

structure of SDQ. Sleep 1994;17:160–7.

[40] Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Ques-

tionnaire in psychopharmacological investigations—a

review. Psychopharmacology (Berl) 1980;71:173–9.

[41] van Dijk L, Kooij DG, Schellevis FG, et al. Nocturia: impact

on quality of life in a Dutch adult population. BJU Int

2004;93:1001–4.

[42] van Diest R, Appels WP. Sleep physiological characteris-

tics of exhausted men. Psychosom Med 1994;56:28–35.

[43] Partinen M, Gislason T. Basic Nordic Sleep Questionnaire

(BNSQ): a quantitated measure of subjective sleep com-

plaints. J Sleep Res 1995;4:150–5.

[44] Buysse DJ, Reynolds III CF, Monk TH, et al. The Pittsburgh

Sleep Quality Index: a new instrument for psychiatric

practice and research. Psychiatry Res 1989;28:193–213.

[45] Welch G, Weinger K, Barry MJ. Quality-of-life impact of

lower urinary tract symptom severity: results from the

Health Professionals Follow-up Study. Urology 2002;59:

245–50.

[46] Barry MJ, Fowler FJ, O’Leary MP, et al. Measuring disease-

specific health status in men with benign prostatic hyper-

plasia. Measurement Committee of The American Urolo-

gical Association. Med Care 1995;33(Suppl):AS145–55.

[47] Lukacs B, Comet D, Grange JC, et al. Construction and

validation of a short-form benign prostatic hypertrophy

health-related quality-of-life questionnaire. BPH Group in

General Practice. Br J Urol 1997;80:722–30.

[48] Barry MJ, Fowler FJ, O’Leary MP, et al. The American

Urological Association symptom index for benign pro-

static hyperplasia. The Measurement Committee of the

American Urological Association. J Urol 1992;148:1549–57.

[49] A comparison of quality of life with patient reported

symptoms and objective findings in men with benign

prostatic hyperplasia. The Department of Veterans

Affairs Cooperative Study of transurethral resection for

benign prostatic hyperplasia. J Urol 1993;150:1696–700.

[50] Donovan JL, Kay HE, Peters TJ, et al. Using the ICSQoL to

measure the impact of lower urinary tract symptoms on

quality of life: evidence from the ICS-‘BPH’ Study. Inter-

national Continence Society—Benign Prostatic Hyperpla-

sia. Br J Urol 1997;80:712–21.

[51] Epstein RS, Deverka PA, Chute CG, et al. Validation of a

new quality of life questionnaire for benign prostatic

hyperplasia. J Clin Epidemiol 1992;45:1431–45.

[52] Girman CJ, Epstein RS, Jacobsen SJ, et al. Natural history of

prostatism: impact of urinary symptoms on quality of life

in 2115 randomly selected community men. Urology

1994;44:825–31.

[53] Hald T, Nordling J, Andersen JT, et al. A patient weighted

symptom score system in the evaluation of uncompli-

cated benign prostatic hyperplasia. Scand J Urol Nephrol

Suppl 1991;138:59–62.

[54] Meyhoff HH, Hald T, Nordling J, et al. A new patient

weighted symptom score system (DAN-PSS-1). Clinical

assessment of indications and outcomes of transurethral

prostatectomy for uncomplicated benign prostatic hyper-

plasia. Scand J Urol Nephrol 1993;27:493–9.

[55] Chapple C, Batista JE, Berges R, et al. The impact of

nocturia in patients with LUTS/BPH: Need for new recom-

mendations. Eur Urol Suppl 2006;5:12–8.

[56] Abraham L, Hareendran A, Mills IW, et al. Development

and validation of a quality-of-life measure for men with

nocturia. Urology 2004;63:481–6.

[57] Avery K, Hashim H, Gardener N, et al. Development and

psychometric evaluation of the ICIQ nocturia module: the

ICIQ-N. Neurourol Urodyn 2004;23:387 (abstract no. 595).

[58] Cai T, Gardener N, Abraham L, et al. Impact of surgical

treatment on nocturia in men with benign prostatic

obstruction. BJU Int 2006;98:799–805.

[59] Bing MH, Moller LA, Jennum P, et al. Validity and reliability

of a questionnaire for evaluating nocturia, nocturnal

e u r o p e a n u r o l o g y s u p p l e m e n t s 6 ( 2 0 0 7 ) 5 7 6 – 5 8 4584

enuresis and sleep-interruptions in an elderly population.

Eur Urol 2006;49:710–9.

[60] Djavan B, Milani S, Davies J, Bolodeoku J. The impact of

tamsulosin oral controlled absorption system (OCAS) on

nocturia and the quality of sleep: preliminary results of a

pilot study. Eur Urol Suppl 2005;4(2):61–8.

[61] Sadeh A, Hauri PJ, Kripke DF, et al. The role of actigraphy

in the evaluation of sleep disorders. Sleep 1995;18:288–

302.

[62] Edinger JD, Means MK, Stechuchak KM, et al. A pilot study

of inexpensive sleep-assessment devices. Behav Sleep

Med 2004;2:41–9.