Web-based Management of Female Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

Detailed Description
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Female urinary incontinence is very common and affects up to one fourth of grownup women. It may reduce quality of life for those affected and costs for society are high. The most common type of urinary incontinence is stress urinary incontinence (SUI), i.e leakage when coughing, sneezing or jumping. There is no association between SUI and serious medical conditions. Thus investigation can be kept to a minimum, including structured history taking and a bladder diary for correct diagnosis. Treatment with lifestyle intervention and pelvic floor muscle training (PFMT) give improvement or cure in 60-70% of women. A small study indicates that treatment with cognitive behavioural therapy (CBT) may improve incontinence-related quality of life and symptoms of urinary incontinence. Web-based management of SUI has as far as we know never been evaluated in a randomized controlled study. The aim of this study is to determine if web-based management of female SUI, with a treatment using PFMT and elements of CBT is effective compared to treatment supported by a pamphlet. The duration of the treatment programme is three months, follow-up at four months, 1 year and two years.

Official Title
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Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy

Conditions
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Female Stress Urinary Incontinence

Intervention / Treatment
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* Behavioral: Web-based treatment with PFMT and elements of CBT
* Behavioral: Pamphlet treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stress urinary incontinence leakage once a week or more often ability to read and write Swedish asset to computer with Internet connection Exclusion Criteria: pregnancy former incontinence surgery known malignancy in lower abdomen difficulties with passing urine visual blood in urine intermenstrual bleeding severe psychiatric diagnosis neurological disease with affection on sensibility in legs or lower abdomen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Web-based treatment<br>Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist | Behavioral: Web-based treatment with PFMT and elements of CBT<br>* 125 women with stress urinary incontinence(SUI) participate in web-based treatment for 3 months. Treatment consists of information, PFMT and uses elements of CBT. It includes regular email contact with urotherapist.<br>|
| Active Comparator: Pamphlet treatment<br>Information (including life style), and PFMT exercises. | Behavioral: Pamphlet treatment<br>* 125 women with SUI receive a pamphlet with information and a programme for PFMT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) | summed symptom-score, range 0-21, with higher scores indicating greater severity. | baseline, 4 months | 
| International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) | condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life. | baseline, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) | health-specific quality of life, range 0-100, higher scores indicate better quality of life. | baseline, 4 months | 
| Usage of Incontinence Aids | Only those using incontinence aids at baseline were included in the analysis. | baseline, 4 months | 
| Patient Satisfaction |  | 4 months | 
| Incontinence Episode Frequency (IEF) | number of incontinence episodes per week | baseline, 4 months | 
| Patient's Global Impression of Improvement Scale (PGI-I) |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, stress urinary incontinence, treatment, pelvic floor muscle training, cognitive behavioral therapy, internet, life style, pamphlet, eHealth