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

Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical Prostatectomy from 2012 to 2018, always performed by the same surgeon

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the proportion of patients with of urinary incontinence	Assessment of the proportion of patients with urinary incontinence after laparoscopic radical prostatectomy	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Consorci Sanitari Integral

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2012
• Primary Completion (Actual): December 3, 2018
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Genital Neoplasms, Male; Prostatic Diseases; Urination Disorders; Prostatic Neoplasms; Urinary Incontinence
• Other Study ID Numbers: 19/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No