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

Primary Purpose

Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Preservation (endopelvic fascia)
Opening (endopelvic fascia)
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preservation (endopelvic fascia)

Opening (endopelvic fascia)

Arm Description

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.

Outcomes

Primary Outcome Measures

Urinary incontinence
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Erectile function
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2015
Last Updated
September 17, 2019
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02526602
Brief Title
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Official Title
Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preservation (endopelvic fascia)
Arm Type
Experimental
Arm Description
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.
Arm Title
Opening (endopelvic fascia)
Arm Type
Active Comparator
Arm Description
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.
Intervention Type
Procedure
Intervention Name(s)
Preservation (endopelvic fascia)
Intervention Description
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
Intervention Type
Procedure
Intervention Name(s)
Opening (endopelvic fascia)
Intervention Description
Robotic assisted radical prostatectomy with opening of endopelvic fascia
Primary Outcome Measure Information:
Title
Urinary incontinence
Description
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Time Frame
1 year
Title
Erectile function
Description
EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications
Description
Clavien-Dindo classification
Time Frame
1 year
Title
Oncologic results: positive surgical margin rate
Description
Positive surgical margin rate as reported in pathological analysis of the removed prostate
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarno Riikonen, MD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33358241
Citation
Siltari A, Riikonen J, Murtola TJ. Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Sexual Function - A Randomized Clinical Trial. J Sex Med. 2021 Feb;18(2):327-338. doi: 10.1016/j.jsxm.2020.11.003. Epub 2020 Dec 23.
Results Reference
derived

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

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