Pelvic Floor Muscle Training for Incontinence in Older Women.

Study Overview
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Brief Summary
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To determine the effect of pelvic floor muscle training in women aged 70 years and over, who have proven stress urinary incontinence. The hypotheses to be tested are: That pelvic floor muscle training is effective in relief of symptoms of stress urinary incontinence as measured by a greater reduction in the number of episodes of incontinence, quantity of urine lost and improvement of quality of life. That women who undertake pelvic floor muscle training will show greater improvement of pelvic floor muscle function than women who have behavioural (bladder) training, as measured by real time transabdominal ultrasound.

Detailed Description
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Urinary incontinence is associated with significant personal stress, shame and social stigma and affects around one-third of women over 60 years of age. It restricts the amount of physical activity and can lead to social isolation and poor health. Pelvic floor muscle re-education by physiotherapists is the most commonly recommended method of conservative management. Although a recent Cochrane review concluded that it was an effective treatment for women with stress and mixed incontinence, there is still no strong evidence for the effectiveness of this intervention in elderly women. It has also been suggested that bladder training alone is equally effective in patients with stress urinary incontinence, urge and mixed incontinence. This is contrary to current clinical experience. It is therefore important to distinguish the relative effectiveness of these interventions used in isolation in order to ensure that urinary incontinence is managed in the most effective and efficient way. Comparisons: pelvic floor muscle training group and bladder training. Assessments will be conducted at baseline, 1 month, 3 months and 5 months during the intervention period. Both groups will then continue with their home program for a further 7 months until their final assessment (Assessment 5). Outcome measures will include: volume of urine lost during a stress test, completion of accident diaries, Degree of 'bother', quality of life using the Kings Health Questionnaire, and assessment of pelvic floor function using real time transabdominal diagnostic ultrasound.

Official Title
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The Effect of Pelvic Floor Muscle Training for the Management of Incontinence in Older Women: a Single Blind Randomised Controlled Trial.

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Behavioral: Pelvic floor muscle training and bladder training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling women aged over 65 years urodynamically proven stress incontinence Medically stable Exclusion Criteria: Already receiving physiotherapy intervention Neurogenic incontinence Cannot comply with training program

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic floor muscle training<br>Weekly group session of education and exercise to music incorporating pelvic floor muscle training incorporating motor control, strength, endurance, power and functional training in a variety of different positions. | Behavioral: Pelvic floor muscle training and bladder training<br> <br> |
| Active Comparator: Bladder training<br>Weekly group session of education regarding deferral techniques, timed voiding parameters and gentle exercise to music. | Behavioral: Pelvic floor muscle training and bladder training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of urine lost over a 7-day period measured by self-report. | Self report of urine leakage | 1, 3, 5 (end of intervention) and 12 months | 
| Urine lost on stress test measured by pad weigh test. | Pad weight following stress test | 1, 3, 5 (end of intervention) and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| King's Health Questionnaire. | Quality of life questionnaire | 1, 3, 5 (end of intervention) and 12 months | 
| Degree of bother | Visual Analogue Scale of degree of bother | 1, 3, 5 (end of intervention) and 12 months | 
| Severity of stress incontinence | Severity of stress incontinence measured by the ICIQ-UI SF | 1, 3, 5 (end of intervention) and 12 months | 
| Displacement of pelvic floor during muscle contraction | Displacement measured using transabdominal ultrasound imaging. | 1, 3, 5 (end of intervention) and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress urinary incontinence, Pelvic floor muscle training, Bladder training, Older women