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

Study 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.

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

Conditions
-----------------
Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction

Intervention / Treatment
-----------------
* Procedure: Preservation (endopelvic fascia)
* Procedure: Opening (endopelvic fascia)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservation (endopelvic fascia)<br>During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved. | Procedure: Preservation (endopelvic fascia)<br>* Robotic assisted radical prostatectomy with preserving of endopelvic fascia<br>|
| Active Comparator: Opening (endopelvic fascia)<br>During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened. | Procedure: Opening (endopelvic fascia)<br>* Robotic assisted radical prostatectomy with opening of endopelvic fascia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery | 1 year | 
| Erectile function | EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Clavien-Dindo classification | 1 year | 
| Oncologic results: positive surgical margin rate | Positive surgical margin rate as reported in pathological analysis of the removed prostate | 1 year |