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Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT00239824
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : July 18, 2016
Sponsor:
Collaborators:
St. Olavs Hospital
Norwegian Fund for Postgraduate Training in Physiotherapy
Fund for Cancer Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
Study Start Date : October 2005
Primary Completion Date : December 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. self reported continence (no need for wearing a pad)at 3 months [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Self reported time period from operation to continence. [ Time Frame: One year ]
  2. 24 hours home pad test registering grams of urine [ Time Frame: One year ]
  3. Pelvic floor muscle strength [ Time Frame: one year ]
  4. Erectile dysfunction [ Time Frame: one year ]
  5. Quality of life [ Time Frame: one year ]
  6. Perceived problems with urinary function [ Time Frame: One year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00239824     History of Changes
Other Study ID Numbers: REK4.2005.211
T-97450/001
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
urinary incontinence
pelvic floor muscle training
radical prostatectomy
physiotherapy

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders