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Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

This study has been completed.
Sponsor:
Collaborators:
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
First received: October 14, 2005
Last updated: March 31, 2008
Last verified: March 2008
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
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.

Other Name: Physiotherapy, pelvic floor muscle training
Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
Active Comparator: 2
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

No publications provided

Responsible Party: Siv Mørkved, associate professor, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00239824     History of Changes
Other Study ID Numbers: REK4.2005.211, T-97450/001
Study First Received: October 14, 2005
Last Updated: March 31, 2008
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

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013