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NCT Number: NCT02526602

Preservation of Endopelvic Fascia: 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.

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Key information

Conditions

Prostatic Neoplasms Erectile Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preservation (endopelvic fascia)

Procedure

Robotic assisted radical prostatectomy with preserving of endopelvic fascia

Opening (endopelvic fascia)

Procedure

Robotic assisted radical prostatectomy with opening of endopelvic fascia

Primary outcomes

  1. Urinary incontinence

    Time frame: 1 year

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

  2. Erectile function

    Time frame: 1 year

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

Secondary outcomes

  1. Complications

    Time frame: 1 year

    Clavien-Dindo classification

  2. Oncologic results: positive surgical margin rate

    Time frame: 1 year

    Positive surgical margin rate as reported in pathological analysis of the removed prostate

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2015
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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