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

September 17, 2019 updated by: Tampere University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Jarno Riikonen, MD, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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