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Completed

NCT Number: NCT00239824

Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

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

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Trondheim, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Drug/alcohol abuse

Treatment and study plan

Strength training of the pelvic floor muscles

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.

Other names: Physiotherapy, pelvic floor muscle training

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

Behavioral

Primary outcomes

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

    Time frame: One year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Fund for Cancer Research
  • Norwegian Fund for Postgraduate Training in Physiotherapy
  • St. Olavs Hospital

Registry information

Official study title

Urinary Incontinence After Radical Prostatectomy. - Effect of Pelvic Floor Muscle Training. A Randomised Controlled Trial

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Oct 17, 2005
Registry last updated
Jul 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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