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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526602
• Other study ID #: R15043
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostatic Neoplasms
• Urinary Incontinence

Intervention

Procedure:
• Preservation (endopelvic fascia)
Robotic assisted radical prostatectomy with preserving of endopelvic fascia
• Opening (endopelvic fascia)
Robotic assisted radical prostatectomy with opening of endopelvic fascia

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary incontinence	EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery	1 year
Primary	Erectile function	EPIC-26 questionnaire preoperatively and 3 and 12 months after surgery	1 year
Secondary	Complications	Clavien-Dindo classification	1 year
Secondary	Oncologic results: positive surgical margin rate	Positive surgical margin rate as reported in pathological analysis of the removed prostate	1 year