NCT02526602

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasms
• Urinary Incontinence
• Erectile Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Preservation (endopelvic fascia)	Robotic assisted radical prostatectomy with preserving of endopelvic fascia
PROCEDURE	Opening (endopelvic fascia)	Robotic assisted radical prostatectomy with opening of endopelvic fascia

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2015-08-18
• Last updated: 2019-09-18

Locations

1 site across 1 country: Finland