Clinical trial NCT00239824: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
pelvic floor muscle training
radical prostatectomy
physiotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: Fund for Cancer Research
First posted: 2005-10-17
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Drug/alcohol abuse

Primary outcomes:
measure: self reported continence (no need for wearing a pad)at 3 months
timeFrame: One year
Secondary outcomes:
measure: Self reported time period from operation to continence.
timeFrame: One year
measure: 24 hours home pad test registering grams of urine
timeFrame: One year
measure: Pelvic floor muscle strength
timeFrame: one year
measure: Erectile dysfunction
timeFrame: one year
measure: Quality of life
timeFrame: one year
measure: Perceived problems with urinary function
timeFrame: One year
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital
Study officials:
affiliation: Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway
name: Siv Mørkved, PhD
role: STUDY_CHAIR
References:
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.