Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
July 15, 2016 updated by: Norwegian University of Science and Technology
Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.
Study Overview
Status
Completed
Conditions
Detailed Description
Urinary incontinence is a well known side effect of radical prostatectomy.
The prevalence differs according to time period after the operation and the definition of incontinence used.
However, a prevalence of 10-20% have been reported one year after the operation.
Pelvic floor muscle training has been suggested as a treatment of urinary incontinence.
The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.We conduct a randomized clinical trial, comparing one group(n=40) following a pelvic floor muscle training program after prostatectomy and one group (n=40) receiving only standard information.Primary outcome variable is self registration of urinary incontinence.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trondheim, Norway
- Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Cancer prostata operated (radical prostatectomy)
- Incontinence after separation of catheter
- Understands Norwegian language
Exclusion Criteria:
- Drug/alcohol abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist
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Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily. Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist.
Other Names:
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Active Comparator: 2
Strength training of the pelvic floor muscles without follow up instructions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
self reported continence (no need for wearing a pad)at 3 months
Time Frame: One year
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One year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Quality of life
Time Frame: one year
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one year
|
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Self reported time period from operation to continence.
Time Frame: One year
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One year
|
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24 hours home pad test registering grams of urine
Time Frame: One year
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One year
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Pelvic floor muscle strength
Time Frame: one year
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one year
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Erectile dysfunction
Time Frame: one year
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one year
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Perceived problems with urinary function
Time Frame: One year
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Siv Mørkved, PhD, Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 17, 2005
Study Record Updates
Last Update Posted (Estimate)
July 18, 2016
Last Update Submitted That Met QC Criteria
July 15, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK4.2005.211
- T-97450/001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.