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

Not Applicable

Completed

• Conditions: Prostatic Neoplasms; Urinary Incontinence; Erectile Dysfunction
• Interventions: Procedure: Preservation (endopelvic fascia); Procedure: Opening (endopelvic fascia)

• Registration Number: NCT02526602
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 158

Inclusion Criteria

• Localized prostate cancer
• Planned nerve-sparing robotic radical prostatectomy
• Gleason score 7 or less

Exclusion Criteria

• Previous prostate surgery (TURP, TUIP, laser...)
• Planned lymphadenectomy
• T3 cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservation (endopelvic fascia)	Preservation (endopelvic fascia)	During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.
Opening (endopelvic fascia)	Opening (endopelvic fascia)	During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.

Primary Outcome Measures

Name	Time	Method
Erectile function	1 year	EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Urinary incontinence	1 year	EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Complications	1 year	Clavien-Dindo classification
Oncologic results: positive surgical margin rate	1 year	Positive surgical margin rate as reported in pathological analysis of the removed prostate

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland