Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.

Detailed Description
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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.

Official Title
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Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Behavioral: Strength training of the pelvic floor muscles
* Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer prostata operated (radical prostatectomy) Incontinence after separation of catheter Understands Norwegian language Exclusion Criteria: Drug/alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist | Behavioral: Strength training of the pelvic floor muscles<br>* 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.<br>* Other names: Physiotherapy, pelvic floor muscle training;Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist<br> <br> |
| Active Comparator: 2<br>Strength training of the pelvic floor muscles without follow up instructions | Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self reported continence (no need for wearing a pad)at 3 months |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported time period from operation to continence. |  | One year | 
| 24 hours home pad test registering grams of urine |  | One year | 
| Pelvic floor muscle strength |  | one year | 
| Erectile dysfunction |  | one year | 
| Quality of life |  | one year | 
| Perceived problems with urinary function |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, pelvic floor muscle training, radical prostatectomy, physiotherapy