Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

NCT ID: NCT00239824

Last Updated: 2016-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

Strength training of the pelvic floor muscles

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

2

Strength training of the pelvic floor muscles without follow up instructions

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Physiotherapy, pelvic floor muscle training

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Drug/alcohol abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role collaborator

Fund for Cancer Research

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siv Mørkved, PhD

Role: STUDY_CHAIR

Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway

Locations

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

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 18448233 (View on PubMed)

Other Identifiers

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T-97450/001

Identifier Type: -

Identifier Source: secondary_id

REK4.2005.211

Identifier Type: -

Identifier Source: org_study_id

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