Web-based Management of Female Stress Urinary Incontinence

Umeå University

Status: Completed

Conditions: Female Stress Urinary Incontinence

Treatments: Behavioral: Pamphlet treatment; Behavioral: Web-based treatment with PFMT and elements of CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01032265

SLS 2008-21468 (Other Identifier)

LVN 8160 (Other Identifier)

JLL LS/1073/2008 (Other Identifier)

Visare Norr Project nr 40/2009 (Other Identifier)

FAS dnr 2008-0952

VLL-68711 (Other Identifier)

VLL 759-2008 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Web-based treatment

Active Comparator group

Description:

Web-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist

Treatment:

Behavioral: Web-based treatment with PFMT and elements of CBT

Pamphlet treatment

Active Comparator group

Description:

Information (including life style), and PFMT exercises.

Treatment:

Behavioral: Pamphlet treatment