Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

Not Applicable

Completed

• Conditions: Urinary Incontinence
• Interventions: 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

• Registration Number: NCT00239824
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-17
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

Inclusion Criteria

• Cancer prostata operated (radical prostatectomy)
• Incontinence after separation of catheter
• Understands Norwegian language

Exclusion Criteria

• Drug/alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Strength training of the pelvic floor muscles	Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist
1	strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist	Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist
2	strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist	Strength training of the pelvic floor muscles without follow up instructions

Primary Outcome Measures

Name	Time	Method
self reported continence (no need for wearing a pad)at 3 months	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital; 🇳🇴 Trondheim, Norway