Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.

Tampere University Hospital1 site in 1 country158 target enrollmentAugust 2015

ConditionsProstatic Neoplasms Urinary Incontinence Erectile Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostatic Neoplasms
Sponsor: Tampere University Hospital
Enrollment: 158
Locations: 1
Primary Endpoint: Erectile function
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Urinary incontinence and impotence are typical disturbances after radical prostatectomy. Although, several surgical methods are developed to decrease these disturbances, 8% and 50% of the patients suffer from permanent urinary incontinence and impotence, respectively.

Previously two studies have shown that endopelvic fascia preservation may decrease postoperative incontinence and impotence rates. Unfortunately these studies are retrospective decreasing their reliability.

The present study is prospective and randomized clinical trial. The investigators are going to randomize 180 patient to preservation and opening the endopelvic fascia groups. Functional and oncological results are followed up to 1 year after surgery.

Detailed Description

180 patients going to radical prostatectomy as treatment of prostate cancer will be randomized 1:1 to two study arms: In the other arm endopelvic fascia are preserved during the operation, in the other arm the fascia are opened. After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

September 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel