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Completed

NCT Number: NCT01032265

Web-based Management of Female Stress Urinary Incontinence

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based treatment with PFMT and elements of CBT

Behavioral

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

Behavioral

125 women with SUI receive a pamphlet with information and a programme for PFMT.

Primary outcomes

  1. International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: baseline, 4 months

    summed symptom-score, range 0-21, with higher scores indicating greater severity.

  2. International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

    Time frame: baseline, 4 months

    condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.

Secondary outcomes

  1. EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)

    Time frame: baseline, 4 months

    health-specific quality of life, range 0-100, higher scores indicate better quality of life.

  2. Usage of Incontinence Aids

    Time frame: baseline, 4 months

    Only those using incontinence aids at baseline were included in the analysis.

  3. Patient Satisfaction

    Time frame: 4 months

  4. Incontinence Episode Frequency (IEF)

    Time frame: baseline, 4 months

    number of incontinence episodes per week

  5. Patient's Global Impression of Improvement Scale (PGI-I)

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Jämtland County Council, Sweden
  • Swedish Council for Working Life and Social Research
  • Västernorrland County Council, Sweden

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 15, 2009
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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