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Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Strength training of the pelvic floor muscles
strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring urinary incontinence, pelvic floor muscle training, radical prostatectomy, physiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Cancer prostata operated (radical prostatectomy) Incontinence after separation of catheter Understands Norwegian language Exclusion Criteria: Drug/alcohol abuse

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Strength training of the pelvic floor muscles without follow up instructions

Outcomes

Primary Outcome Measures

self reported continence (no need for wearing a pad)at 3 months

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2005
Last Updated
July 15, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Fund for Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00239824
Brief Title
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy
Official Title
Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy, Fund for Cancer Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinence, pelvic floor muscle training, radical prostatectomy, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist
Arm Title
2
Arm Type
Active Comparator
Arm Description
Strength training of the pelvic floor muscles without follow up instructions
Intervention Type
Behavioral
Intervention Name(s)
Strength training of the pelvic floor muscles
Other Intervention Name(s)
Physiotherapy, pelvic floor muscle training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist
Primary Outcome Measure Information:
Title
self reported continence (no need for wearing a pad)at 3 months
Time Frame
One year
Secondary Outcome Measure Information:
Title
Self reported time period from operation to continence.
Time Frame
One year
Title
24 hours home pad test registering grams of urine
Time Frame
One year
Title
Pelvic floor muscle strength
Time Frame
one year
Title
Erectile dysfunction
Time Frame
one year
Title
Quality of life
Time Frame
one year
Title
Perceived problems with urinary function
Time Frame
One year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cancer prostata operated (radical prostatectomy) Incontinence after separation of catheter Understands Norwegian language Exclusion Criteria: Drug/alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siv Mørkved, PhD
Organizational Affiliation
Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
18448233
Citation
Overgard M, Angelsen A, Lydersen S, Morkved 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.2008.04.021. Epub 2008 Apr 18.
Results Reference
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Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

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