Web-based Management of Female Stress Urinary Incontinence

Female Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032265
• Other study ID #: FAS dnr 2008-0952
• Secondary ID: VLL 759-2008VLL-
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2022
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Female Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Web-based treatment with PFMT and elements of CBT
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.
• Pamphlet treatment
125 women with SUI receive a pamphlet with information and a programme for PFMT.

Locations

Country	Name	City	State
Sweden	Umea University	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Jämtland County Council, Sweden, Swedish Council for Working Life and Social Research, Västernorrland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Usage of Incontinence Aids	Only those using incontinence aids at baseline were included in the analysis.	baseline, 4 months
Secondary	Patient Satisfaction		4 months
Secondary	Incontinence Episode Frequency (IEF)	number of incontinence episodes per week	baseline, 4 months
Secondary	Patient's Global Impression of Improvement Scale (PGI-I)		4 months

External Links

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