Web-based Management of Female Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Female Stress Urinary Incontinence
• Interventions: Behavioral: Web-based treatment with PFMT and elements of CBT; Behavioral: Pamphlet treatment

• Registration Number: NCT01032265
• Lead Sponsor: Umeå University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-12
• Study First Submitted QC: 2009-12-12
• Study First Posted: 2009-12-15
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-12-17
• Results First Submitted QC: 2013-02-08
• Results First Posted: 2013-03-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web-based treatment	Web-based treatment with PFMT and elements of CBT	Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
Pamphlet treatment	Pamphlet treatment	Information (including life style), and PFMT exercises.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Umea University; 🇸🇪 Umeå, Sweden