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Web-based Management of Female Stress Urinary Incontinence

This study has been completed.
Sponsor:
Collaborators:
Swedish Council for Working Life and Social Research
Jämtland County Council, Sweden
Västernorrland County Council, Sweden
Information provided by (Responsible Party):
Eva Samuelsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01032265
First received: December 12, 2009
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Female Stress Urinary Incontinence
 Behavioral: Web-based treatment with PFMT and elements of CBT
Behavioral: Pamphlet treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF) [ Time Frame: baseline, 4 months ] [ Designated as safety issue: No ]
    summed symptom-score, range 0-21, with higher scores indicating greater severity.

  • International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) [ Time Frame: baseline, 4 months ] [ Designated as safety issue: No ]
    condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.


Secondary Outcome Measures:
  • EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS) [ Time Frame: baseline, 4 months ] [ Designated as safety issue: No ]
    health-specific quality of life, range 0-100, higher scores indicate better quality of life.

  • Usage of Incontinence Aids [ Time Frame: baseline, 4 months ] [ Designated as safety issue: No ]
    Only those using incontinence aids at baseline were included in the analysis.

  • Patient Satisfaction [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Incontinence Episode Frequency (IEF) [ Time Frame: baseline, 4 months ] [ Designated as safety issue: No ]
    number of incontinence episodes per week

  • Patient`s Global Impression of Improvement Scale (PGI-I) [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: December 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Web-based treatment
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
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.
Active Comparator: Pamphlet treatment
Information (including life style), and PFMT exercises.
 Behavioral: Pamphlet treatment
125 women with SUI receive a pamphlet with information and a programme for PFMT.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032265

Locations
Sweden
Umea University
Umeå, Sweden, S-90185
Sponsors and Collaborators
Umeå University
Swedish Council for Working Life and Social Research
Jämtland County Council, Sweden
Västernorrland County Council, Sweden
Investigators
Study Chair: Eva Samuelsson, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
Principal Investigator: Eva Samuelsson, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
Principal Investigator: Göran Umefjord, MD, PhD Department of Public Health and Clinical Medicine, Umeå University
  More Information

Additional Information:
Click here for more information on this study. Web-based management of female stress urinary incontinence. Evaluation of a treatment programme using pelvic floor muscle training and elements of cognitive behavioural therapy.  This link exits the ClinicalTrials.gov site

No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eva Samuelsson, Associate professor, Umeå University
ClinicalTrials.gov Identifier: NCT01032265     History of Changes
Other Study ID Numbers: FAS dnr 2008-0952, VLL 759-2008, VLL-68711, SLS 2008-21468, Visare Norr Project nr 40/2009, JLL LS/1073/2008, LVN 8160
Study First Received: December 12, 2009
Results First Received: December 17, 2012
Last Updated: February 8, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Umeå University:
female
stress urinary incontinence
treatment
pelvic floor muscle training
cognitive behavioral therapy
 internet
life style
pamphlet
eHealth

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013