Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks

Completed

• Conditions: Urinary Incontinence; Surgical Procedure, Unspecified; Prostatic Cancer

• Registration Number: NCT04043637
• Lead Sponsor: Consorci Sanitari Integral

Brief Summary

This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

Detailed Description

This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.

Study Timeline

• Study Start: 2012-04-23
• Primary Completion: 2018-12-03
• Study Completion: 2019-04-10
• Status Verified: 2019-07
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• Age between 40 and 75 years
• A Body Mass Index lower than 35 Hg/m2
• Patients with organ-confined prostate cancer
• Signed informed consent

Exclusion Criteria

• Contraindications for Laparoscopy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in the proportion of patients with of urinary incontinence	The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery	Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy

Secondary Outcome Measures

Name	Time	Method
change in the proportion of patients with recovery of the erectile function	every month during the first year after surgery	assessment of the recovery of the erectile function after surgery
number of patients with overall positive surgical margins	immediate postoperative period	postoperative assessment of positive surgical margins
biochemical recurrence rate	until the completion of the study, with a mean follow-up of 72 months