Exercise intervention in the management of urinary incontinence

Lancet Glob Health, 2019, 7: e 923– 31 Lancet Glob Health Reproductive, maternal, neonatal,

Adrian Wagg • University of Alberta • Urodynamics • Gerontology

Contents 01 Introduction 02 Methods 03 Results 04 Discussion 05 Conclusions

Introduction 6 • Urinary incontinence is a common condition with a profound e�ect on

Introduction 7 A study • more than 43 000 villagers • aged 60 years

Introduction 8 The primary endpoint: to determine whether an intervention that comprised PFMT and

Study design and participants 10 Villages selection : 1. from six districts of Bangladesh

Study design and participants 11 Participants: Included criteria： • women • aged 60– 75

Randomisation and masking 12 • 16 pairs of villages • was randomly assigned •

Procedures 13 a pre-test 01 • in two villages • to develop a culturally

14 03 04 a location • was accessible on foot in which exercise classes

Procedures 05 visited the home • • 06 15 3 days later, both the

Procedures 07 08 16 Visited each woman at home • After four exercise classes

Procedures 17 the education-only group • including the initial meeting with explanation of the

Section 1. Training of physiotherapists in general (mobility) exercises 19

Section 2: Training for the physiotherapists in pelvic floor muscle exercises 22

Data collected 23 at baseline collection method at 24 weeks a home visit demographic

Outcomes • The primary outcome: change in number of urinary leakage episodes. • Secondary

25 Data Analysis proportions or mean (SD) Summarise demographic information on the participants t

28 • All 32 villages completed the intervention and are included in the analysis.

Results 33 The proportion of women who were cured： • the exercise plus education

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Discussion 35 • successful in decreasing urinary incontinence and increasing dryness in women •

Discussion 36 This exercise intervention di�ers in two respects: • First, the exercise therapy

Discussion Strengths of this study: • Successful randomization of clusters, with close similarity between

38 Limitations of the study: 1. not spoken by the Canadian investigators. • The

39 3. Finally, in the first of 32 villages, some initial lack of understanding

Conclusions 41 • The innovation here is that, when incorporated with mobility exercises in

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Exercise intervention in the management of urinary incontinence in older women in villages in Bangladesh: a cluster randomised trial 任洁琼

Lancet Glob Health, 2019, 7: e 923– 31 Lancet Glob Health Reproductive, maternal, neonatal, child, and adolescent health; infectious diseases, including neglected tropical diseases; non-communicable diseases; mental health; the global health workforce; health systems; surgery; and health policy.

Adrian Wagg • University of Alberta • Urodynamics • Gerontology

Contents 01 Introduction 02 Methods 03 Results 04 Discussion 05 Conclusions

01 Introduction

Introduction 6 • Urinary incontinence is a common condition with a profound e�ect on wellbeing and quality of life. • can be managed by use of exercise-based interventions • but little is known about whether these interventions would be feasible or e�ective in developing countries.

Introduction 7 A study • more than 43 000 villagers • aged 60 years or older • 30% reported urinary incontinence • strongly associated with depression A Cochrane review • Pelvic ﬂoor muscle training (PFMT) is e�ective Smaller trials • mobility or strength training to be e�ective No large-scale studies None of the evidence • on exercise interventions is from women in poor villages in low-income countries

Introduction 8 The primary endpoint: to determine whether an intervention that comprised PFMT and mobility exercises plus bladder education would be more e�ective than bladder education alone in decreasing urinary incontinence in older women in the villages who have little recourse to other treatment.

02 Methods

Study design and participants 10 Villages selection : 1. from six districts of Bangladesh 2. 12 health centres that covered 52 villages had good records. 3. From the 52 villages, the principal investigator (NC) selected the 16 study pairs first by eliminating villages with few women in the target age range. 4. pairs were matched up with similar proportions of poor or very poor inhabitants.

Study design and participants 11 Participants: Included criteria： • women • aged 60– 75 years • were identifed by use of the family card • had current urinary incontinence • Consent was signifed by a witnessed thumbprint after a verbal explanation of the purpose of the trial and of the processes Excluded criteria： • had a uterine prolapse of third degree or higher • they did not meet one or more of these criteria the paramedic assessed：were able to stand from sitting/walk without help, and had the intellectual capacity to understand the paramedic’s questions and follow instructions.

Randomisation and masking 12 • 16 pairs of villages • was randomly assigned • to the exercise plus education group and the other to the education-only group • use of a random number generator from a fixed seed • 16 sealed, opaque, numbered envelopes by a third party and the other investigators and the field workers were masked to allocation. • Women in the villages were told only about the intervention to which they had been allocated.

Procedures 13 a pre-test 01 • in two villages • to develop a culturally appropriate exercise plan and to test a 3 -day continence record trained 02 • 3 days • Physiotherapists : to run the exercise class • research paramedics: to run the education intervention, how to complete questionnaires, and how to use the ribbon belt to record urinary leakage.

14 03 04 a location • was accessible on foot in which exercise classes could be held with privacy A meeting • All eligible women • Gave them 3 -day continence record belt A group education session on how the urinary system works and how to maintain good bladder habits. • The physiotherapist explained PFMT and described arrangements for the exercise classes • The research paramedic then visited each woman at home to ask for consent and to collect baseline data.

Procedures 05 visited the home • • 06 15 3 days later, both the research paramedic and physiotherapist visited the home. The research paramedic reinforced the education message and the physiotherapist then gave individual training to the woman on pelvic ﬂoor exercises. The exercise intervention • Entailed 60 min of group exercises done twice weekly for 12 weeks, followed by 30 min of brisk walking. • The exercises included both PFMT and mobility exercises. • The exercise group was led by one of three community physiotherapists.

Procedures 07 08 16 Visited each woman at home • After four exercise classes • the physiotherapist to identify any problems in carrying out home exercises and to reinforce the PFMT. At the end of 12 weeks • the physiotherapist moved to a new village • the research paramedic remained to encourage home exercise, reinforce the education message, and collect data at home visits. • the research paramedic organised group exercises in weeks 13– 24 and women were o�ered the option of these extra classes.

Procedures 17 the education-only group • including the initial meeting with explanation of the 3 -day continence record • except without the physiotherapist-led training in, and practice of, PFMT and mobility exercises • without the home visit from the physiotherapist.

Education intervention 18

Section 1. Training of physiotherapists in general (mobility) exercises 19

20 Side Bend

Section 2: Training for the physiotherapists in pelvic floor muscle exercises 22

Data collected 23 at baseline collection method at 24 weeks a home visit demographic data and measured height and weight √ A urine sample the presence of white cells amoxicillin (500 mg every 12 h for 7 days) √ the five-dimensional Euro. Qo. L Questionnaire (EQ 5 D )：a visual analogue score of health state and subscales √ √ the ten-item Centre for Epidemiologic Studies Depression Scale (CES-D-10 ) √ √ Proportion of participants cured adverse events 3 -day continence record belt √ from week 1 to week 20（ In the exercise plus education villages ） from week 4 to week 20

Outcomes • The primary outcome: change in number of urinary leakage episodes. • Secondary outcomes : health state， EQ 5 D, CES-D-10 24

25 Data Analysis proportions or mean (SD) Summarise demographic information on the participants t test number of leakage episodes and secondary outcomes measured on a continuous scale the bootstrap method to estimate CIs We assessed changes at the village level in the five subscales of the EQ 5 D and proportion of participants cured at 24 weeks multilevel model-based evaluation adjusting for village level and participantlevel random e�ects using a linear mixed model Stata version 15. 1 for statistical analyses.

03 Results

28 • All 32 villages completed the intervention and are included in the analysis. • The number of women in each village ranged from 12 to 27, with a median of 17 women per village.

Results 29

Results 30

Results 33 The proportion of women who were cured： • the exercise plus education group ： 41% (IQR 26– 64) • The education-only villages ： 0 The adverse events： • No adverse events were reported.

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Discussion 35 • successful in decreasing urinary incontinence and increasing dryness in women • improvement in both intervention groups in the quality-of-life and depression scales • less likely to report pain or discomfort • no reports of adverse events.

Discussion 36 This exercise intervention di�ers in two respects: • First, the exercise therapy was delivered in a group setting rather than one-on-one. • Second, the approach aimed to improve mobility as well as pelvic ﬂoor muscle strength.

Discussion Strengths of this study: • Successful randomization of clusters, with close similarity between groups in potential confounders at baseline and a high rate of completion. • The belt and ribbon continence record was developed for this study. 37

38 Limitations of the study: 1. not spoken by the Canadian investigators. • The pre-test period with an initial two-village test of the acceptability of the exercise program 2. The villages had been unmasked to their assigned intervention before obtaining consent, rather than after consent. • given the need to negotiate an exercise location and the high proportion of women whose refusal to participate was triggered by family members, the ideal of disclosure after consent was probably impracticable.

39 3. Finally, in the first of 32 villages, some initial lack of understanding in the use of the belt is apparent, with very few recorded leakage episodes (despite high scores on the UDI short form 16) during the first 16 weeks, with the number of epsiodes recorded increasing thereafter. • This village, which was in the education group, was the only one in which this pattern was seen. • Data from this village have been included in the analysis and might have resulted in a slightly conservative estimate of intervention e�ect.

Conclusions 41 • The innovation here is that, when incorporated with mobility exercises in a group setting, PFMT is possible and e�ective among some of the world’s least privileged older women who would otherwise have little or no help in managing this distressing and pervasive condition.

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