Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy - Full Text View

Sponsors and Collaborators:	Norwegian University of Science and Technology St. Olavs Hospital Norwegian Fund for Postgraduate Training in Physiotherapy Fund for Cancer Research
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00239824

Purpose

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

Condition	Intervention
Urinary Incontinence	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

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

self reported continence (no need for wearing a pad)at 3 months [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self reported time period from operation to continence. [ Time Frame: One year ] [ Designated as safety issue: No ]
24 hours home pad test registering grams of urine [ Time Frame: One year ] [ Designated as safety issue: No ]
Pelvic floor muscle strength [ Time Frame: one year ] [ Designated as safety issue: No ]
Erectile dysfunction [ Time Frame: one year ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
Perceived problems with urinary function [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	October 2005
Study Completion Date:	January 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist	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. Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
2: Active Comparator 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

Arms

Assigned Interventions

1: Experimental

Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist

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.

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

2: Active Comparator

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Drug/alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239824

Locations

Norway
Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital
Trondheim, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Norwegian Fund for Postgraduate Training in Physiotherapy

Fund for Cancer Research

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

More Information

Responsible Party:	Norwegian University of Science and Technology ( Siv Mørkved, associate professor )
Study ID Numbers:	REK4.2005.211, T-97450/001
Study First Received:	October 14, 2005
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00239824
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

urinary incontinence
pelvic floor muscle training
radical prostatectomy
physiotherapy

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009