NCT02526602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

4.1 years

First QC Date

August 10, 2015

Last Update Submit

September 17, 2019

Conditions

Prostatic NeoplasmsUrinary IncontinenceErectile Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Urinary incontinence

    EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery

    1 year

  • Erectile function

    EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery

    1 year

Secondary Outcomes (2)

  • Complications

    1 year

  • Oncologic results: positive surgical margin rate

    1 year

Study Arms (2)

Preservation (endopelvic fascia)

EXPERIMENTAL

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.

Procedure: Preservation (endopelvic fascia)

Opening (endopelvic fascia)

ACTIVE COMPARATOR

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.

Procedure: Opening (endopelvic fascia)

Interventions

Preservation (endopelvic fascia)PROCEDURE

Robotic assisted radical prostatectomy with preserving of endopelvic fascia

Preservation (endopelvic fascia)
Opening (endopelvic fascia)PROCEDURE

Robotic assisted radical prostatectomy with opening of endopelvic fascia

Opening (endopelvic fascia)

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Localized prostate cancer
  • Planned nerve-sparing robotic radical prostatectomy
  • Gleason score 7 or less

You may not qualify if:

  • Previous prostate surgery (TURP, TUIP, laser...)
  • Planned lymphadenectomy
  • T3 cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

Related Publications (1)

  • 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.

    PMID: 33358241DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary IncontinenceErectile Dysfunction

Interventions

Preservation, Biological

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Jarno Riikonen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)