Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239824
• Other study ID #: REK4.2005.211
• Secondary ID: T-97450/001
• Status: Completed
• Phase: N/A
• First received: October 14, 2005
• Last updated: July 15, 2016
• Start date: October 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cancer prostata operated (radical prostatectomy)

• Incontinence after separation of catheter

• Understands Norwegian language

Exclusion Criteria:

• Drug/alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Behavioral:
• Strength training of the pelvic floor muscles
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.
• strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist

Locations

Country	Name	City	State
Norway	Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Fund for Cancer Research, Norwegian Fund for Postgraduate Training in Physiotherapy, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Overgård M, Angelsen A, Lydersen S, Mørkved S. Does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised controlled trial. Eur Urol. 2008 Aug;54(2):438-48. doi: 10.1016/j.eururo.2008.04. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self reported continence (no need for wearing a pad)at 3 months		One year	No
Secondary	Self reported time period from operation to continence.		One year	No
Secondary	24 hours home pad test registering grams of urine		One year	No
Secondary	Pelvic floor muscle strength		one year	No
Secondary	Erectile dysfunction		one year	No
Secondary	Quality of life		one year	No
Secondary	Perceived problems with urinary function		One year	No