Clinical trial · Interventional
Preservation of Endopelvic Fascia: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
Preservation of Endopelvic Fascia During Radical Prostatectomy: Effects on Postoperative Incontinence and Impotence. Randomized Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Urinary Incontinence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opening (endopelvic fascia) | Procedure | — | UNRESOLVED |
| Preservation (endopelvic fascia) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Preservation (endopelvic fascia)
- description
- During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.
- interventionNames
- Procedure: Preservation (endopelvic fascia)
- type
- ACTIVE_COMPARATOR
- label
- Opening (endopelvic fascia)
- description
- During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.
- interventionNames
- Procedure: Opening (endopelvic fascia)
Primary outcomes (2)
- measure
- Urinary incontinence
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSiltari 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. PMID 33358241