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

Tampere University Hospital

Status: Completed

Conditions: Erectile Dysfunction; Prostatic Neoplasms; Urinary Incontinence

Treatments: Procedure: Preservation (endopelvic fascia); Procedure: Opening (endopelvic fascia)

Study type: Interventional

Funder types: Other

Identifiers

NCT02526602

R15043

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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158 participants in 2 patient groups

Preservation (endopelvic fascia)

Experimental group

Description:

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are preserved.

Treatment:

Procedure: Preservation (endopelvic fascia)

Opening (endopelvic fascia)

Active Comparator group

Description:

During robotic assisted laparoscopic radical prostatectomy endopelvic fascia are opened.

Treatment:

Procedure: Opening (endopelvic fascia)