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

NCT02526602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2019-09-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Jarno Riikonen, MD · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526602 on ClinicalTrials.gov