Integrated care for older people (ICOPE) Guidelines on community-level interventions to manage declines in intrinsic capacity

Evidence profile: urinary incontinence

Scoping question: Do non-pharmacological interventions (prompted voiding, timed voiding, toilet training, habit retraining, pelvic floor muscle training) produce any benefit and/or harm for older people with urinary incontinence?

The full ICOPE guidelines and complete set of evidence profiles are available at who.int/ageing/publications/guidelines-icope

Painting: “Wet in Wet” by Gusta van der Meer. At 75 years of age, Gusta has an artistic style that is fresh, distinctive and vibrant. A long-time lover of art, she finds that dementia is no barrier to her artistic expression. Appreciated not just for her art but also for the support and encouragement she gives to other artists with dementia, Gusta participates in a weekly art class. Copyright by Gusta van der Meer. All rights reserved Evidence profile: urinary incontinence

Contents

Background ...... 1 Part 1: Evidence review ...... 2 Scoping question in PICO format (population, intervention, comparison, outcome) ...... 2 Search strategy ...... 3 List of systematic reviews identified by the search process ...... 3 PICO table ...... 4 Narrative description of the systematic reviews included in the analysis ...... 5 Brief descriptions of the included non-pharmacological interventions ...... 6 GRADE table 1: Prompted voiding versus no prompted voiding for adults with urinary incontinence ...... 8 GRADE table 2: Pelvic floor muscle training (PFMT) with or without biofeedback plus other interventions versus no active control for older people with urinary incontinence ...... 10 GRADE table 3: Habit retraining plus others compared with usual care for older people (men and women) with urinary incontinence ...... 12 GRADE table 4: Pelvic floor muscle training (PFMT) compared with no treatment for older women with urinary incontinence ...... 13 GRADE table 5: Bladder training versus no treatment for older people with urinary incontinence ...... 15 GRADE table 5.1: Bladder training versus other behavioural interventions for older people with other incontinence ...... 16 GRADE table 6: Timed voiding plus other versus usual care for older people with urinary incontinence ...... 17 Part 2: From evidence to recommendations ...... 18 Summary of evidence ...... 18 Evidence-to-recommendations table ...... 20 Guideline development group recommendation and remarks ...... 24 References ...... 26 Annex 1: Search strategy ...... 28 Annex 2: PRISMA 2009 flow diagram for non-pharmacological intervention for managing urinary incontinence ...... 30

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ICOPE guidelines – World Health Organization 1 Evidence profile: urinary incontinence

Background Several chronic conditions and environmental factors increase the risk of urinary incontinence in older people. Chronic diseases Urinary incontinence, the involuntary loss of urine, is a highly that are associated with urinary incontinence include diabetes prevalent condition in older people aged 60 years and over (1). mellitus, Parkinson’s disease, dementia, stroke, prostatic cancer, The common types of urinary incontinence in older people are chronic obstructive pulmonary disease (COPD) and arthritis. stress incontinence and urge incontinence. Stress incontinence is Environmental factors such as inaccessible or unsafe toilet the involuntary leaking of urine during efforts or exertion, or while facilities, and the absence of caregivers for toileting assistance sneezing or coughing. Urge incontinence, or overactive bladder are also associated with urinary incontinence. Non- syndrome, involves a constellation of symptoms including pharmacological interventions are mostly preferred and remain frequency, urgency and leakage immediately preceded by urgency. the mainstay of urinary incontinence management for patients The prevalence of urinary incontinence reported in population- with mild urinary incontinence. The primary goal of urinary based studies ranges from 9.9% to 36.1% (2–4), and is twice as incontinence interventions is to improve continence by reducing high in older women as in older men. Urinary incontinence has a the frequency of urinary incontinence episodes. The non- profound impact on the quality of life of older people, their pharmacological interventions addressed in this guideline include subjective health status (5, 6), levels of depression (7) and need pelvic floor muscle training (PFMT), bladder training and habit for care (8). retraining, and timed or prompted voiding.

ICOPE guidelines – World Health Organization 2 Evidence profile: urinary incontinence

Part 1: Evidence review

Scoping question in PICO format (population, intervention, comparison, outcome)

Population • Older people with urgency or stress or mixed urinary incontinence

Interventions • Prompted voiding • Timed voiding • Bladder training • Habit retraining • Pelvic floor muscle training (PFMT)

Comparison • No intervention/usual care

Outcomes • Critical: Proportion of mean change in frequency of urinary incontinence, change in mean proportion of hourly checks that are wet, number of patients with reductions in incidence of daytime incontinence, number of patients with reductions in incidence of night-time incontinence, incontinent episodes in 24 hours, mean urinary incontinence incidence per 24 hours, urinary incontinence symptoms • Important: Perceived cure, self-initiated toileting, median percentage of checks wet, number of incontinent episodes, urinary incontinence urgency, urinary incontinence frequency, nocturia, quality of life

ICOPE guidelines – World Health Organization 3 Evidence profile: urinary incontinence

Search strategy — Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the A systematic literature search for reviews was conducted in Ovid management of urinary incontinence in adults. Cochrane Database MEDLINE, Embase, PsycINFO and Cochrane databases. The Syst Rev. 2004;(2):CD002801. Updated in 2009. [Systematic details of the search terms used for retrieving studies are provided review was updated by WHO in 2015] (10) in Annex 1. The search retrieved 188 reviews and 798 randomized controlled trials (RCTs). After initial screening for eligibility, 111 — Eustice S, Roe B, Paterson J. Prompted voiding for the reviews and 161 RCTs were considered for full-text review. management of urinary incontinence in adults. Cochrane Database Ultimately, five systematic reviews that included 25 RCTs and two Syst Rev. 2000;(2):CD002113. Updated in 2006. [Systematic additional studies investigating the benefits of non-pharmacological review was updated by WHO in 2015] (11) interventions were included in this review (see Annex 2). — Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the List of systematic reviews identified by the search management of urinary incontinence in adults. Cochrane Database process Syst Rev. 2004;(1):CD002802. Updated in 2009. [Systematic review was updated by WHO in 2015] (12) Included in GRADE1 tables — Dumoulin C, Hay-Smith EJC, Mac Habée-Séguin G. Pelvic floor — Wallace SA, Roe B, Williams K, Palmer M. Bladder training for muscle training versus no treatment, or inactive control treatments, urinary incontinence in adults. Cochrane Database Syst Rev. for urinary incontinence in women. Cochrane Database Syst Rev. 2004;(1):CD001308. Updated in 2009. [Systematic review was 2014;(5):CD005654 (13) updated by WHO in 2015] (9)

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1 GRADE: Grading of Recommendations Assessment, Development and Evaluation. More information: http://gradeworkinggroup.org

ICOPE guidelines – World Health Organization 4 Evidence profile: urinary incontinence

PICO table

Intervention/ Outcomes Studies used for GRADE comparison

1 Timed voiding plus others • Number of patients with reductions in incidence of Ostaszkiewicz J, Johnston L, Roe B. Timed vs usual care daytime urinary incontinence voiding for the management of urinary • Number of patients with reductions in incidence of incontinence in adults. Cochrane Database night-time incontinence Syst Rev. 2004;(1):CD002802. Updated in • Number of patients whose pad test indicates 2009. (12) reduction in the volume of incontinence

2 Prompted voiding vs no • Number of patients with no improvement in urinary Eustice S, Roe B, Paterson J. Prompted prompted voiding incontinence episodes voiding for the management of urinary • Change in mean proportion of hourly checks that are incontinence in adults. Cochrane Database wet Syst Rev. 2000;(2):CD002113. Updated in • urinary incontinence episodes in 24 hours 2006. (11) • Self-initiated toileting

3 Habit retraining plus • Number of incontinent episodes Ostaszkiewicz J, Johnston L, Roe B. Habit others vs usual care • Incontinent volume retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801. Updated in 2009. (10)

4 Bladder training vs no • Cure rate Wallace SA, Roe B, Williams K, Palmer M. treatment or active • Number of micturition episodes Bladder training for urinary incontinence in treatment controls adults. Cochrane Database Syst Rev. 2004;(1):CD001308. Updated in 2009. (9) (continued next page)

ICOPE guidelines – World Health Organization 5 Evidence profile: urinary incontinence

5 Pelvic floor muscle • Mean urinary incontinence incidence per 24 hours Dumoulin C, Hay-Smith EJC, Mac Habée- training plus bladder • Urinary incontinence urgency Séguin G. Pelvic floor muscle training versus retraining vs control no treatment, or inactive control treatments, • Urinary incontinence frequency for urinary incontinence in women. Cochrane • Nocturia Database Syst Rev. 2014;(5):CD005654. (13)

Narrative description of the systematic reviews CINAHL, PsycINFO, Biological Abstracts, Current Contents and the included in the analysis reference lists of relevant articles. Experts in the field were also contacted for potential papers. The search included relevant websites and hand searches of journals and conference The Cochrane systematic review by Wallace et al. (updated in proceedings. Four trials with a total of 378 participants met the 2009) aimed to synthesise evidence for effectiveness of bladder inclusion criteria. Participants in these trials (mean age 80 years) training for urinary incontinence in adults (9). Relevant trials were were mainly women and they were physically and/or cognitively identified from the Cochrane Incontinence Review Group’s impaired, dependent on caregivers and residing either in nursing specialized register of controlled trials, which contains trials homes or in their own homes. Three trials tested habit retraining identified from MEDLINE, the Cumulative Index to Nursing and combined with other treatment, compared with usual care (14–16) Allied Health Literature (CINAHL) and the Cochrane Central and another trial compared the combination treatment with habit Register of Controlled Trials (CENTRAL). The specialized register retraining alone (17). was searched using the Review Group’s own keywords and medical search terms. The review included 12 RCTs (total of 1473 The Cochrane systematic review by Eustice et al. (updated in 2006) participants). The participants were predominantly female (75%). aimed mainly to examine the effectiveness of prompted voiding in Eight included trials had useable data but only four of them included the management of urinary incontinence in adults (11). The search older people aged over 60 years. Three of the trials were conducted for trials was conducted in the Cochrane Incontinence Review in the United States of America and another study is a multicentre Group’s specialized register of controlled trials (31 January 2006) trial that included participants from Denmark, Norway and Sweden. as well as the reference lists of relevant articles. Investigators in the

field were also contacted for additional studies. As a result, nine The Cochrane systematic review by Ostaszkiewicz et al aimed to trials with a total 674 participants (mean age 84 years) were investigate the benefit of habit retraining in the management of included in the review. The majority of participants included in the urinary incontinence in adults (10). Trials were identified from the trials were older women. Prompted voiding was compared with no search conducted in the Cochrane Incontinence Review Group’s specialized register of controlled trials, MEDLINE, Embase, (continued next page)

ICOPE guidelines – World Health Organization 6 Evidence profile: urinary incontinence prompted voiding in nine trials. One trial was excluded as the ages identify potential studies. Twenty-one trials involving 1281 women of the trial participants were not reported (18). (665 PFMT, 616 controls) met the inclusion criteria. Seven of them recruited older people aged over 60 years or had mean participant Ostaszkiewicz et al. (updated in 2009) is a Cochrane systematic age of more than 60 years (21–27). review on timed voiding for the management of urinary incontinence in adults (12). The search for trials was conducted in Cochrane Two additional RCTs, not listed in the above-mentioned Cochrane Incontinence Review Group’s specialized register of controlled trials systematic reviews, were identified in an independent literature (searched 2 April 2009), MEDLINE (January 1966 to November search and were also included (28, 29). 2003), Embase (January 1980 to Week 18 2002), CINAHL (January 1982 to February 2001), PsycINFO (January 1972 to August 2002), Brief descriptions of the included non- Biological Abstracts (January 1980 to December 2000), Current pharmacological interventions Contents (January 1993 to December 2001) and the reference lists of relevant articles. Experts in the field were contacted for potential Prompted voiding is administered for older people with or without studies. The search included relevant websites and conference cognitive impairment to initiate their own toileting through requests proceedings. Hand searches were also conducted in relevant for help, and includes the use of positive reinforcement from carers journals. Two trials with a total of 298 participants met the inclusion when they do this. This is distinct from some other therapies criteria (19, 20). Both compared timed voiding plus additional because of the participation of the individual in the process. In intervention with usual care. Most of the participants from the two contrast, habit retraining attempts to determine the micturition selected trials were cognitively impaired elderly women (mean age pattern for an individual, which can be used to achieve continence 86.7 years) and all resided in facilities that provided nursing care. but does not necessarily rely on the individual’s participation. The majority of participants (82%) in one study were older Timed voiding is fixed by time or event, and is carer led and is not women (19) while the other study did not report the sex of an individualized intervention. Bladder training actively includes the participants (20). individual in attempting to increase the interval between the desire to void and the actual void, and hence would not be suitable for Dumoulin et al. is a Cochrane systematic review of pelvic floor those who are cognitively impaired. It comprises three components: muscle training (PFMT) versus no treatment, or inactive control (a) patient education – information about the bladder and how treatments, for urinary incontinence in women (13). The search for continence is usually maintained; (b) scheduled voiding – a relevant trials was conducted in the Cochrane Incontinence Review “timetable for voiding” which may be fixed or flexible to suit the Group’s specialized register of controlled trials, which contains trials participant’s rate of increase in the interval between voids (the aim identified from CENTRAL (1999 onwards), MEDLINE (1966 is usually to achieve an interval of 3–4 hours between voids); and onwards) and MEDLINE In-Process (2001 onwards). Conference (c) positive reinforcement – psychological support and proceedings were searched (15 April 2013), and hand searches were done in the journals and reference lists of relevant articles to (continued next page)

ICOPE guidelines – World Health Organization 7 Evidence profile: urinary incontinence encouragement is generally considered important and is usually the toilet seat and adjusting the garment) to improve toilet timing. provided by a health care professional. Pelvic floor muscle training Functional incidental training combines prompted voiding with (PFMT) is an exercise programme of repeated pelvic floor muscle functionally oriented, low-intensity endurance exercises (e.g. timed contractions taught and supervised by a health care professional, at sit-to-stands, walking or wheelchair mobility) and strengthening times combined with bladder training for individuals with mixed exercises (e.g. bicep curls, straight-arm raises, knee extensions urinary incontinence. and hip abductions and flexions).

Other physical exercise interventions – such as Treatment adherence. There is limited evidence on adherence to functional incidental training, mobility and toileting training – focus non-pharmacological treatments. Adherence reported in four on improving the ability of older people to reach the toilet or included RCTs ranges from 72% to 89% (30–33). developing related skills (e.g. getting up from bed or a chair, walking 5 metres, undoing clothing hooks, zippers and buttons, Adverse events. The included trials neither performed explicit letting down the garment, sitting down on the toilet, rising up from assessment for adverse events nor reported any major risks.

ICOPE guidelines – World Health Organization 8 Evidence profile: urinary incontinence

GRADE table 1: Prompted voiding versus no prompted voiding for adults with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is prompted voiding more effective than no prompted voiding when used for adults with urinary incontinence (urge, stress, mixed)? Settings: Community Bibliography: (11) Eustice S, Roe B, Paterson J. Prompted voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2000;(2):CD002113. Updated in 2006

Quality assessment Number of patients Effect

Quality Importance

Number of Risk of Other Prompted No prompted Relative Design Inconsistency Indirectness Imprecision Absolute studies bias considerations voiding voiding (95% CI)

Mean proportion of hourly checks that are wet (follow-up 32 weeks; measured with diary and report; lower score = better performance)

1 randomized serious a not serious serious b serious c none 73 74 – MD -12.00  CRITICAL trials lower (-18.79 VERY LOW to -5.21 lower)

(continued next page)

ICOPE guidelines – World Health Organization 9 Evidence profile: urinary incontinence

Change in mean proportion of hourly checks that are wet (follow-up 8 weeks; measured with diary and self-report; lower score = better performance)

1 randomized serious d no serious no serious very serious e none 9 10 – MD 17.60  CRITICAL trials imprecision indirectness higher (-14.58 VERY LOW lower to 49.78 higher)

Number of incontinent episodes in 24 hours (follow-up 3–13 weeks; measured with diary and self-report; lower score = better performance)

2 randomized serious f serious g serious h no serious none 127 130 – MD –0.92  CRITICAL trials imprecision lower (-1.32- VERY LOW to –0.53 lower)

Self-initiated toileting (follow-up 3 weeks; measured with self-report; lower score = better performance)

1 randomized serious i no serious serious j serious k none 63 63 – MD –1.90  IMPORTANT trials imprecision lower (-2.29 LOW to -1.51 lower)

CI: confidence interval; MD: mean difference a. Risk of bias: Downgraded once as allocation concealment was unclear in one trial. b. Indirectness: Downgraded once as trial was conducted in nursing home setting, and generalizing the evidence to other settings is doubtful. c. Imprecision: Downgraded once as sample size was small (smaller than 200). d. Risk of bias: Downgraded once as method applied for allocation concealment was unclear. e. Imprecision: Downgraded twice as sample size was very small (smaller than 50). f. Risk of bias: Downgraded once as allocation concealment method was unclear in two trials. g. Inconsistency: Downgraded once as considerable heterogeneity was observed: Chi2 = 18.07, df = 1 (P = 0.00002); I2 = 94%. h. Indirectness: Downgraded once as included trials were conducted in nursing home settings and generalizing the interventions to other settings is doubtful. i. Risk of bias: Downgraded once as allocation concealment was unclear. j. Indirectness: Downgraded once as trial was conducted in nursing home setting and generalizing the interventions to other settings is doubtful. k. Imprecision: Downgraded once as sample size was small (smaller than 200).

ICOPE guidelines – World Health Organization 10 Evidence profile: urinary incontinence

GRADE table 2: Pelvic floor muscle training (PFMT) with or without biofeedback plus other interventions versus no active control for older people with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is multicomponent behavioural interventions (PFMT with or without biofeedback, bladder control strategy, education and self-monitoring) more effective than no active control when used for older people (women and men) with urinary incontinence? Setting: Community Bibliography: (34) McFall SL, Yerkes AM, Cowan LD. Outcomes of a small group educational intervention for urinary incontinence: episodes of incontinence and other urinary symptoms. J Aging Health. 2000;12(2):250–67. (21) Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M et al. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998;280(23):1995–2000. (35) Goode PS, Burgio KL, Locher JL, Umlauf MG, Lloyd LK, Roth DL. Urodynamic changes associated with behavioral and drug treatment of urge incontinence in older women. J Am Geriatr Soc. 2002;50(5):808–16. (36) Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002;100(1):72–8. (37) Dougherty MC, Dwyer JW, Pendergast JF, Boyington AR, Tomlinson BU, Coward RT et al. A randomized trial of behavioral management for continence with older rural women. Res Nurs Health. 2002;25(1):3–13. (38) Johnson TM, Burgio KL, Redden DT, Wright KC, Goode PS. Effects of behavioral and drug therapy on nocturia in older incontinent women. J Am Geriatr Soc. 2005;53(5):846–50. (continued next page)

ICOPE guidelines – World Health Organization 11 Evidence profile: urinary incontinence

Quality assessment Number of patients Effect

Multicomponent behavioural Quality Importance Number interventions (PFMT No active Relative of Design Risk of Other with or without Absolute Inconsistency Indirectness Imprecision control (95% CI) studies bias considerations biofeedback plus bladder control strategy and self- monitoring)

Total number of incontinent episodes per week (post treatment) (follow-up 6–24 weeks; assessed with bladder diary; lower score = better performance)

a 5 randomized serious no serious no serious no serious none 382 327 – WMD -3.63  CRITICAL trials inconsistency indirectness imprecision lower (-5.19 MODERATE to -0.99 lower)

Patients’ perception of improvement in urinary incontinence (follow-up 6–8 weeks; assessed with self-report and bladder diary; improvement was defined as self-reported improvement or no restriction in daily activities)

3 randomized serious b no serious no serious no serious none 165/234 65/174 RR 4.15 339 more per  IMPORTANT trials inconsistency indirectness imprecision (70.5%) (37.4%) (2.70 to 6.37) 1000 (from MODERATE 243 more to 418 more)

CI: confidence interval; RR: relative risk; WMD: weighted mean difference a. Risk of bias: Downgraded once as method applied for allocation concealment was unclear in all five included trials b. Risk of bias: Downgraded once as method applied for allocation concealment was not clear in all three included trials.

ICOPE guidelines – World Health Organization 12 Evidence profile: urinary incontinence

GRADE table 3: Habit retraining plus others compared with usual care for older people (men and women) with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is habit retraining plus others more effective than usual care when used for older people (men and women) with urinary incontinence? Setting: Community Bibliography: (10) Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2): CD002801. Updated in 2009. [Systematic review was updated by WHO in 2015].

Quality assessment Number of patients Effect

Quality Importance Number Risk of Other Habit retraining Usual Relative of Design Inconsistency Indirectness Imprecision Absolute bias considerations plus other care (95% CI) studies

Number of incontinent episodes (follow-up 6–36 weeks; assessed with bladder diary; lower score = better performance)

2 randomized serious a no serious no serious serious b none 76 54 – SMD 0.12  CRITICAL trials inconsistency indirectness lower (0.47 LOW lower to 0.23 higher)

CI: confidence interval; MD: mean difference a. Risk of bias: Downgraded once as allocation concealment was unclear in one of the included trial. b. Imprecision: Downgraded once as sample size was small (smaller than 200).

ICOPE guidelines – World Health Organization 13 Evidence profile: urinary incontinence

GRADE table 4: Pelvic floor muscle training (PFMT) compared with no treatment for older women with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is PFMT more effective than no treatment or placebo when used for older women with urinary incontinence? Settings: Primary care or community Bibliography: (13) Dumoulin C, Hay-Smith EJC, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014;(5):CD005654.

Quality assessment Number of patients Effect

Quality Importance Pelvic floor Number of Risk of Other No treatment Relative Design Inconsistency Indirectness Imprecision muscle Absolute studies bias considerations or education (95% CI) training

Participant perceived cure (all types of urinary incontinence) (follow-up 12 weeks; assessed with self-reported information)

3 randomized serious a serious b no serious no serious none 50/144 9/146 RR 5.34 (2.78 268 more per  IMPORTANT trials indirectness imprecision (34.7%) (6.2%) to 10.26) 1000 (from 110 LOW more to 571 more)

Quality of life (follow-up 6 weeks; measured with King’s Health Questionnaire (KHQ)/severity measure after treatment; lower score = better performance)

1 randomized serious c not serious no serious very serious d none 30 15 – MD -24.92  IMPORTANT trials applicable indirectness lower (-39.06 VERY LOW lower to -10.78 lower)

(continued next page)

ICOPE guidelines – World Health Organization 14 Evidence profile: urinary incontinence

Urinary incontinence symptoms (follow-up 6 weeks; measured with: King’s health questionnaire; Better indicated by lower values)

2 randomized serious e not serious no serious very serious d none 30 30 – MD -34.16  CRITICAL trials indirectness lower VERY LOW (-47.45 lower to -20.88 lower)

CI: confidence interval; MD: mean difference; RR: relative risk. a. Risk of bias: Downgraded once as allocation concealment method and procedure for masking outcome assessor was unclear in one trial. b. Inconsistency: Downgraded once as moderate heterogeneity was observed: Chi2 = 7.56, df = 2 (P = 0.02); I2 = 74%. c. Risk of bias: Downgraded once as outcome assessor was not masked and method applied for allocation concealment was unclear. d. Imprecision: Downgraded twice as sample size was very small (smaller than 100). e. Risk of bias: Downgraded once as allocation concealment method was unclear in one trial.

ICOPE guidelines – World Health Organization 15 Evidence profile: urinary incontinence

GRADE table 5: Bladder training versus no treatment for older people with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is bladder training more effective than no treatment, placebo or control when used for older people (male and female) with urinary incontinence? Settings: Community Bibliography: (9) Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD001308. Updated in 2009. [Systematic review was updated by WHO in 2015]

Quality assessment Number of patients Effect Quality Importance

Number of Risk of Other Bladder No treatment Relative Design Inconsistency Indirectness Imprecision Absolute studies bias considerations training control (95% CI)

Cure of incontinent episodes (follow-up 6 weeks; assessed with diary, number of participants cured, immediately after treatment)

b 1 randomized serious a not serious no serious serious none 7/60 2/63 RR 3.68 85 more per  CRITICAL trials indirectness (11.7%) (3.2%) (0.79 to 1000 (from 7 LOW 16.99) fewer to 508 more)

Number of micturition episodes per week (daytime) (follow-up 6 weeks; assessed with diary immediately after the treatment phase; lower score = better performance)

d 1 randomized serious c not serious no serious very serious none 45 43 – MD -0.31  IMPORTANT trials indirectness lower (-0.73 VERY lower to 0.11 LOW higher)

CI: confidence interval; MD: mean difference; RR: relative risk. a. Risk of bias: Downgraded once as method applied for allocation concealment was unclear. b. Imprecision: Downgraded once as sample size was small (smaller than 200). c. Risk of bias: Downgraded once as information on incomplete data not described adequately. d. Imprecision: Downgraded twice as sample size was very small (smaller than 100).

ICOPE guidelines – World Health Organization 16 Evidence profile: urinary incontinence

GRADE table 5.1: Bladder training versus other behavioural interventions for older people with other incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is bladder training more effective than other behavioural, physical, psychological treatments when used for older people with other incontinence? Settings: Primary care or community Bibliography: (9) Wallace SA, Roe B, Williams K, Palmer M. Bladder training for urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD001308. Updated in 2009. [Systematic review was updated by WHO in 2015]

Quality assessment Number of patients Effect

Quality Importance Other behavioural, Number of Other Bladder physical, Relative Design Risk of bias Inconsistency Indirectness Imprecision Absolute studies considerations training psychological (95% CI) treatment

Participant’s perception of improvement: improved, cured vs unchanged, worse; minimum of 2 months post-treatment (follow-up 12 weeks)

1 randomized serious a not serious no serious serious b none 37/60 45/60 RR 0.88 90 fewer  IMPORTANT trials indirectness (61.7%) (75%) (0.68 to 1.13) per 1000 LOW (from 240 fewer to 97 more)

CI: confidence interval; RR: relative risk. a. Risk of bias: Downgraded once as outcome assessor was not masking in the trial and incomplete data was not managed adequately. b. Imprecision: Downgraded once as sample size was smaller than 200.

ICOPE guidelines – World Health Organization 17 Evidence profile: urinary incontinence

GRADE table 6: Timed voiding plus other versus usual care for older people with urinary incontinence

Author: WHO systematic review team Date: 11 November 2015 Question: Is timed voiding plus other more effective than usual care when used for older people (men and women) with urinary incontinence? Settings: Primary care or community Bibliography: (12) Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802. Updated in 2009. [Systematic review updated by WHO in 2015]

Quality assessment Number of patients Effect

Quality Importance Timed Number of Risk of Other Relative Design Inconsistency Indirectness Imprecision voiding plus Usual care Absolute studies bias considerations (95% CI) other

Number of patients with reductions in incidence of daytime incontinence (follow-up 8 weeks)

1 randomized serious a not serious serious b serious 4 none 40/120 26/89 RR 1.34 (0.9 99 more per  CRITICAL trials (33.3%) (29.2%) to 2.01) 1000 (from VERY LOW 29 fewer to 295 more)

Number of patients with reductions in incidence of night-time incontinence (follow-up 8 weeks)

1 randomized serious c not serious serious b serious d none 39/95 18/79 RR 1.80 182 more  CRITICAL trials a (41.1%) (22.8%) (1.12 to 2.89) per 1000 VERY LOW (from 27 more to 431 more)

CI: confidence interval; RR: relative risk a. Risk of bias: Downgraded once as trial method was quasi-experimental design. b. Indirectness: Downgraded once as trial was conducted in nursing home settings in high income country and generalizing the evidence to other settings is doubtful. c. Risk of bias: Downgraded once as allocation concealment method and procedure for masking of outcome assessor was unclear in the trial. d. Imprecision: Downgraded once as sample size was small.

ICOPE guidelines – World Health Organization 18 Evidence profile: urinary incontinence

Part 2: From evidence to recommendations

Summary of evidence

Outcome Effect size

Prompted voiding Habit retraining Pelvic-floor PFMT vs no Bladder training Timed voiding vs vs no promoted plus other vs muscle training treatment, vs no treatment usual care voiding usual care (PFMT) with or placebo, control without controls

biofeedback, bladder retraining and self-monitoring vs control

GRADE table 1 MD -12 lower Eustace et al. (11) (-18.79 lower to -5.21 lower) Mean proportion of Favours treatment hourly checks that are VERY LOW wet

Change in mean MD -17.60 higher proportion of hourly (-14.58 lower to 49.78 checks that are wet higher) VERY LOW Total number of urinary MD -0.92 lower SMD -0.12 lower WMD -3.63 lower incontinence episodes (-1.32 lower to -0.53 (-0.47 lower to (-5.19 lower lower) 0.23 higher) to -0.99 lower) Favours treatment LOW Favours treatment VERY LOW MODERATE (continued next page)

ICOPE guidelines – World Health Organization 19 Evidence profile: urinary incontinence

Self-initiated toileting MD -1.9 lower (-2.29 lower to -1.51 lower) Favours treatment LOW

GRADE table 5 RR 4.15 RR 0.88 Wallace et al. (9) (2.70 to 6.37) (0.68 to 1.13) Favours treatment LOW Patients’ perception of MODERATE improvement in urinary incontinence

Cure of incontinent RR 3.68 episodes (0.79 to 16.99) LOW

Number of micturition per MD -0.31 lower week (daytime) (-0.73 lower to 0.11 higher) VERY LOW

GRADE table 6 RR 1.34 Ostaszkiewicz et al. (12) (0.90 to 2.01) VERY LOW Number of patients with reductions in incidence of daytime incontinence

Number of patients with RR 1.80 reductions in incidence (1.12 to 2.89) of nighttime incontinence Favours treatment VERY LOW

GRADE table 4 RR 5.34

Dumoulin et al. (13) (2.78 to 10.26)

Participant perceived Favours treatment cure LOW (continued next page)

ICOPE guidelines – World Health Organization 20 Evidence profile: urinary incontinence

MD -34.16 lower Urinary incontinence symptoms (-47.45 to -20.88 lower) Favours treatment VERY LOW

Quality of life MD -24.92 lower (-39.06 lower to -10.78 lower) Favours treatment VERY LOW

Evidence-to-recommendations table

Problem Explanation

Is the problem a priority? The prevalence of urinary incontinence reported in population-based studies ranges from 9.9% Yes No Uncertain to 36.1%, and is twice as high in older women as in older men. Urinary incontinence has a profound impact on the quality of life of older people, their subjective health status, levels of ✓

depression and need for care.

Benefits and harms Explanation

Do the desirable effects outweigh the No studies reported harm associated with non-pharmacological management of urinary undesirable effects? incontinence. Yes No Uncertain There is limited low-quality evidence which suggests that prompted voiding may benefit older ✓

people in managing urinary incontinence. Eight trials included in this analysis investigated the benefit of prompted voiding compared with no prompted voiding for older people with urinary incontinence. All of the analysed trials were conducted in the United States. Seven of the eight studies were carried out in nursing home settings. The duration of the interventions ranged from

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ICOPE guidelines – World Health Organization 21 Evidence profile: urinary incontinence

(continued from previous page) 20 days to 32 weeks. Two trials reported the effectiveness of prompted voiding in terms of reducing the number of urinary incontinence episodes in 24 hours. Both Hu et al. (39) and Do the desirable effects outweigh the Schnelle et al. (40) found a reduction in the number of incontinent episodes per day in the undesirable effects? prompted voiding group. The pooled result was statistically significant (weighted mean Yes No Uncertain difference [WMD]: -0.92, CI: 95% -1.32 to -0.53). Two other trials reported a similar outcome, ✓ but could not be included in the meta-analysis. One of them reported a substantial reduction in

the number of incontinent episodes (60% lower) in the treatment group compared with the control group (37%). Another trial found a significant decrease in incontinence, falling from 80% to 20%, in the treatment group, whereas the control group remained almost the same.

There is adequate moderate-quality evidence suggesting that pelvic floor muscle training

(PFMT) combined with bladder training benefits older women to manage urinary incontinence. Six randomized controlled trials (RCTs), with a total of 1132 participants, investigated the benefit of PFMT combined with bladder training with or without biofeedback. All six RCTs recruited older people living in the community; five of them recruited older people aged over 55 years, while in the other trial, participants were aged 65 years and over. The intervention was delivered at home or in clinical settings. The mean age of the study participants ranged from 65.4 to 74.7 years. In one trial, nearly 34% of study participants were older men; all other

studies only recruited older women.

Three of the six trials tested PFMT with biofeedback and a bladder control strategy with or without self-monitoring. One RCT examined PFMT without biofeedback, bladder training or self- monitoring. Two other RCTs combined PFMT with other behavioural interventions: one used a group education approach consisting of bladder training, a strategy to manage the urge to urinate, and group support for PFMT, while the other trial administered PFMT and bladder training with individualized voiding schedules. Apart from one trial that offered a self-help

booklet to the control group, the control groups in all the other trials received no active intervention.

Five of the analysed trials reported outcome data on the number of incontinence episodes per week. The overall pooled effect of PFMT plus bladder training, with or without biofeedback, was

(continued next page) ICOPE guidelines – World Health Organization 22 Evidence profile: urinary incontinence

(continued from previous page) WMD: -3.63 (-5.19 to -0.99 lower), favouring the treatment (P < 0.001). Three trials reported data on participants’ perception of improvement in urinary incontinence. The pooled estimate for Do the desirable effects outweigh the this outcome was relative risk [RR]: 4.14 (95% CI: 2.70 to 6.37) in favour of the treatment group. undesirable effects? Yes No Uncertain No trial has reported adverse effects, and the guideline development group guideline ✓ development group believed that the potential for harm is likely to be minimal.

Values and preferences/ acceptability Explanation

Is there important uncertainty or Urinary incontinence in older people is associated with significant societal cost, and it impacts variability about how much people value older people and family caregivers profoundly. The magnitude of the problem is larger in low- the options? and middle-income countries (LMICs): 9% to 36% of older people suffer from urinary Major Minor Uncertain incontinence. The majority of them receive care from a close family member, who may be at risk variability variability of caregiver strain and burden. ✓

Is the option acceptable to key Although there is an absence of evidence from low- and middle-income countries, the evidence stakeholders? reported in high-income countries indicates that non-pharmacological interventions may be Major Minor Uncertain acceptable to older people in low-resource settings. variability variability ✓

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ICOPE guidelines – World Health Organization 23 Evidence profile: urinary incontinence

Feasibility/resource use Explanation

How large are the resource Non-pharmacological interventions recommended for urinary incontinence are not resource requirements? intensive. Major Minor Uncertain ✓

Is the option feasible to implement? The feasibility of these interventions is not an important limitation; these interventions can be safely administered by family caregivers. Delivery of care through non-specialist health workers Yes No Uncertain seems to be a successful model for low- and middle-income countries. Delivering an ✓ educational intervention has been shown to be feasible and to have promising results. Drawing

on these experiences, the guideline development group believed the recommendation was feasible to implement in high- and low-resource settings.

Equity Explanation

Would the option improve equity in The guideline development group strongly believed that this recommendation would increase health? equity in health.

Yes No Uncertain ✓

ICOPE guidelines – World Health Organization 24 Evidence profile: urinary incontinence

Guideline development group recommendation and remarks

Recommendation

Prompted voiding for the management of urinary incontinence can be offered for older people with cognitive impairment. Strength of the recommendation: Conditional Quality of evidence: Very low

Pelvic floor muscle training (PFMT), alone or combined with bladder control strategies and self-monitoring, should be recommended for older women with urinary incontinence (urge, stress or mixed). Strength of the recommendation: Strong Quality of evidence: Moderate

Remarks

• Apart from one study, all of the trials were conducted in high-income countries. • Although the majority of PFMT trials involved older women, the recommendation for PFMT may be applicable to older men. • The duration of the PFMT intervention trials ranged from 6 to 12 weeks and most of the trials administered the interventions on a daily regimen. • Using continence products should be considered for older people who are bedridden or experiencing severe declines in mental and/or physical capacities. • Health care providers should take a detailed history and ask specific questions about urinary incontinence, such as the time of onset, symptoms and frequency.

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ICOPE guidelines – World Health Organization 25 Evidence profile: urinary incontinence

• At least half of women with urinary incontinence do not report this issue to their general practitioner; therefore, health care professionals should routinely check for urinary incontinence in older women and men. • Identifying and managing conditions that may cause urinary incontinence, including urinary tract infections, metabolic disorders, excess fluid intake and impaired mental conditions (e.g. delirium), are important and should not be neglected. • Clinicians should review current medications that may cause or worsen urinary incontinence. • Although pharmacological therapy can reduce urinary incontinence and even provide complete continence, many older people discontinue medication because of adverse effects. Specialist care providers should be consulted when initiating pharmacological treatment. • As a first-line treatment, provide advice on bladder training for a minimum of six weeks. Bladder training involves advising the older people to follow a strict schedule for bathroom visits. The schedule starts with bathroom visits every 2 hours, but the time between visits should be gradually increased to improve bladder control.

ICOPE guidelines – World Health Organization 26 Evidence profile: urinary incontinence

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New York (NY): Springer Publishing; 1992:196–204. cognitively impaired homebound older adults. J Wound Ostomy 21. Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Continence Nurs. 2002;29(5):252–65. Dombrowski M, Candib D. Behavioral vs drug treatment for urge 31. McDowell BJ, Engberg S, Sereika S, Donovan N, Jubeck ME, Weber urinary incontinence in older women: a randomized controlled trial. E et al. Effectiveness of behavioral therapy to treat incontinence in JAMA. 1998;280(23):1995–2000. homebound older adults. J Am Geriatr Soc. 1999;47(3):309–18. 22. Burns PA, Pranikoff K, Nochajski TH, Hadley EC, Levy KJ, Ory MG. A 32. Tobin GW, Brocklehurst JC. The management of urinary incontinence comparison of effectiveness of biofeedback and pelvic muscle in local authority residential homes for the elderly. Age Ageing. exercise treatment of stress incontinence in older community-dwelling 1986;15(5):292–8. women. J Gerontology. 1993;48(4):M167–74. 33. Ouslander JG, Griffiths PC, McConnell E, Riolo L, Kutner M, Schnelle 23. Kim H, Suzuki T, Yoshida Y, Yoshida H. Effectiveness of J. Functional incidental training: a randomized, controlled, crossover multidimensional exercises for the treatment of stress urinary trial in Veterans Affairs nursing homes. J Am Geriatr Soc. incontinence in elderly community-dwelling Japanese women: a 2005;53(7):1091–100. randomized, controlled, crossover trial. J Am Geriatr Soc. 34. McFall SL, Yerkes AM, Cowan LD. Outcomes of a small group 2007;55(12):1932–9. educational intervention for urinary incontinence: episodes of 24. Kim H, Yoshida H, Suzuki T. The effects of multidimensional exercise incontinence and other urinary symptoms. J Aging Health. treatment on community-dwelling elderly Japanese women with stress, 2000;12(2):250–67. urge, and mixed urinary incontinence: a randomized controlled trial. Int 35. Goode PS, Burgio KL, Locher JL, Umlauf MG, Lloyd LK, Roth DL. J Nurs Stud. 2011;48(10):1165–72. Urodynamic changes associated with behavioral and drug treatment of 25. Miller JM, Ashton-Miller JA, DeLancey JO. A pelvic muscle urge incontinence in older women. J Am Geriatr Soc. 2002;50(5):808– precontraction can reduce cough-related urine loss in selected women 16. with mild SUI. J Am Geriatr Soc. 1998;46(7):870–4. 36. Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The 26. Pereira VS, Correia GN, Driusso P. Individual and group pelvic floor effect of behavioral therapy on urinary incontinence: a randomized muscle training versus no treatment in female stress urinary controlled trial. Obstet Gynecol. 2002;100(1):72–8. incontinence: a randomized controlled pilot study. Eur J Obstet 37. Dougherty MC, Dwyer JW, Pendergast JF, Boyington AR, Tomlinson Gynecol Reprod Biol. 2011;159(2):465–71. BU, Coward RT et al. A randomized trial of behavioral management 27. Goode PS, Burgio KL, Kraus SR, Kenton K, Litman HJ, Richter HE, for continence with older rural women. Res Nurs Health.2002;25(1):3– Urinary Incontinence Treatment N. Correlates and predictors of patient 13. satisfaction with drug therapy and combined drug therapy and 38. Johnson TM, Burgio KL, Redden DT, Wright KC, Goode PS. Effects of behavioral training for urgency urinary incontinence in women. Int behavioral and drug therapy on nocturia in older incontinent women. J Urogynecol J Pelvic Floor Dysfunct. 2011;22(3):327–34. Am Geriatr Soc. 2005;53(5):846–50. 28. Pereira VS, de Melo MV, Correia GN, Driusso P. Vaginal cone for 39. Hu TW, Igou JF, Kaltreider DL, Yu LC, Rohner TJ, Dennis PJ et al. A postmenopausal women with stress urinary incontinence: randomized, clinical trial of a behavioral therapy to reduce urinary incontinence in controlled trial. Climacteric. 2012;15(1):45–51. nursing homes: outcome and implications. JAMA. 1989;261(18):2656– 29. Lee HH, Lee SW, Song CH,. The influence of pelvic muscle training 62. program on lower urinary tract symptom, maximum vaginal contraction 40. Schnelle JF, Traughber B, Sowell VA, Newman DR, Petrilli CO, Ory M. pressure, and pelvic floor muscle activity in aged women with stress Prompted voiding treatment of urinary incontinence in nursing home urinary incontinence. Korean J Sport Sci. 2009;20(3):466–74. patients. A behavior management approach for nursing home staff. J 30. Engberg S, Sereika SM, McDowell BJ, Weber E, Brodak I. Am Geriatr Soc. 1989;37(11):1051–7. Effectiveness of prompted voiding in treating urinary incontinence in

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Annex 1: Search strategy

MEDLINE database supplementary concept, rare disease supplementary concept, title, original title, abstract, name of substance word, subject heading 1. exp behavior therapy/ word, unique identifier] 2. (behav$ adj25 therapy).mp. [mp=protocol supplementary 11. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 9 or 10 concept, rare disease supplementary concept, title, original title, 12. exp Urinary Incontinence/ or urinary incontinence.mp. abstract, name of substance word, subject heading word, unique [mp=protocol supplementary concept, rare disease identifier] supplementary concept, title, original title, abstract, name of 3. exp cognitive therapy/ substance word, subject heading word, unique identifier] 4. (cognit$ adj25 therapy).mp. [mp=protocol supplementary 13. 11 and 12 concept, rare disease supplementary concept, title, original title, 14. 13 not child.mp. [mp=protocol supplementary concept, rare abstract, name of substance word, subject heading word, unique disease supplementary concept, title, original title, abstract, name identifier] of substance word, subject heading word, unique identifier] 5. (conservat$ adj25 intervention$).mp. [mp=protocol 15. exp randomized controlled trials/ supplementary concept, rare disease supplementary concept, title, 16. randomized controlled trial.pt. original title, abstract, name of substance word, subject heading 17. exp random allocation/ word, unique identifier] 18. exp double blind method/ 6. toilet training.mp. [mp=protocol supplementary concept, rare 19. exp single blind method/ disease supplementary concept, title, original title, abstract, name 20. exp Clinical Trial/ of substance word, subject heading word, unique identifier] 21. clinical trial.pt. 7. (habit training or habit retraining).mp. [mp=protocol 22. (clin$ adj25 trial$).ti,ab. supplementary concept, rare disease supplementary concept, title, 23. ((singl$ or doubl$ or treb$ or tripl$) adj25 (blind$ or original title, abstract, name of substance word, subject heading mask$)).ti,ab. word, unique identifier] 24. placebo$.ti,ab. 8. timed void$.mp. [mp=protocol supplementary concept, rare 25. random$.ti,ab. disease supplementary concept, title, original title, abstract, name 26. research design/ of substance word, subject heading word, unique identifier] 27. placebos.mp. [mp=protocol supplementary concept, rare 9. prompted void$.mp. [mp=protocol supplementary concept, rare disease supplementary concept, title, original title, abstract, name disease supplementary concept, title, original title, abstract, name of substance word, subject heading word, unique identifier] of substance word, subject heading word, unique identifier] 28. or/15-27 10. (nursing homes and urinary incontinence).mp. [mp=protocol 29. 14 and 28 (continued next page) ICOPE guidelines – World Health Organization 29 Evidence profile: urinary incontinence

30. exp Aged/ or exp Aging/ 23. (balance$ adj2 block$).tw. 31. exp Frail Elderly/ 24. or/1-23 32. 30 or 31 25. (nonhuman not human).sh. 33. 29 and 32 26. 24 not 25 27. behavior modification/ or behavior therapy/ Embase database 28. (conservat$ adj25 (intervention$ or therap$)).tw. 29. conservative treatment/ 1. Randomized Controlled Trial/ 30. (behav$ adj25 (therap$ or train$ or treatment$ or 2. controlled study/ intervention$)).tw. 3. clinical study/ 31. (habit adj2 (train$ or retrain$)).tw. 4. major clinical study/ 32. (void$ adj2 (time$ or prompt$ or schedul$)).tw. 5. prospective study/ 33. toilet$.tw. 6. meta-analysis/ 34. or/27-33 7. exp clinical trial/ 35. bladder disease/ or bladder dysfunction/ or detrusor 8. randomization/ dyssynergia/ or neurogenic bladder/ 9. crossover procedure/ or double blind procedure/ or parallel 36. (continen$ or incontinen$).tw. design/ or single blind procedure/ 37. exp Incontinence/ 10. Placebo/ 38. 37 or 35 or 36 11. latin square design/ 39. 26 and 34 and 38 12. exp comparative study/ 40. limit 39 to (embryo or infant or child or preschool child <1 to 6 13. follow up/ years> or school child <7 to 12 years> or adolescent <13 to 17 14. pilot study/ years>) 15. family study/ or feasibility study/ or pilot study/ or study/ 41. limit 39 to (adult <18 to 64 years> or aged <65+ years>) 16. placebo$.tw. 42. 40 not 41 17. random$.tw. 43. 39 not 42 18. (clin$ adj25 trial$).tw. 44. aging/ or aging.mp. 19. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or 45. frail elderly.mp. or frail elderly/ mask$)).tw. 46. 44 or 45 20. factorial.tw. 47. 43 and 46 21. crossover.tw. 22. latin square.tw.

ICOPE guidelines – World Health Organization 30 Evidence profile: urinary incontinence

Annex 2: PRISMA2 2009 flow diagram for non-pharmacological intervention

for managing urinary incontinence

Records identified Additional records through database identified through searching (n = 1893) other sources (n = 19)

Identification

Records after duplicates removed (n = 986)

Records excluded (n = 714) Records screened (n = 986) • Conference abstract (n = 146) Screening • Pharmacological intervention (n = 568)

Full-text articles assessed for eligibility (n = 272) • Systematic reviews (SR) = 111 Full-text articles excluded, with reasons (n = 265) • Randomized controlled trials (RCTs) = 161 Eligibility Reasons for RCT exclusion: • Inappropriate age group (n = 123) Studies included in qualitative synthesis • Insufficient information on outcomes (n = 36) • SR = 111 • RCTs = 161 Reasons for review exclusion: • Not SR (n = 54) • Quality assessment not performed (n = 29)

Studies included in quantitative synthesis • More recent reviews available (n = 23) (meta-analysis) (n = 27) • SR = 25 RCTs

• Additional studies = 2 RCTs Inclusion

______

2 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). For more information: http://www.prisma-statement.org ICOPE guidelines – World Health Organization