Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
NCT ID: NCT02526602
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2015-08-31
2019-09-30
Brief Summary
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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.
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Detailed Description
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After the operation urinary continence and erection function are compared between the study arms. Additionally the investigators will study oncological outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Preservation (endopelvic fascia)
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.
Preservation (endopelvic fascia)
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
Opening (endopelvic fascia)
During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.
Opening (endopelvic fascia)
Robotic assisted radical prostatectomy with opening of endopelvic fascia
Interventions
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Preservation (endopelvic fascia)
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
Opening (endopelvic fascia)
Robotic assisted radical prostatectomy with opening of endopelvic fascia
Eligibility Criteria
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Inclusion Criteria
* Planned nerve-sparing robotic radical prostatectomy
* Gleason score 7 or less
Exclusion Criteria
* Planned lymphadenectomy
* T3 cancer
18 Years
80 Years
MALE
No
Sponsors
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Tampere University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jarno Riikonen, MD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Locations
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Tampere University Hospital
Tampere, , Finland
Countries
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References
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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.
Other Identifiers
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R15043
Identifier Type: -
Identifier Source: org_study_id
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