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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043637
• Other study ID #: 19/24
• Status: Completed
• Start date: April 23, 2012
• Est. completion date: April 10, 2019

Study information

• Verified date: July 2019
• Source: Consorci Sanitari Integral
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 10, 2019
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Prostatic Cancer
• Prostatic Neoplasms
• Surgical Procedure, Unspecified
• Urinary Incontinence

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari Integral

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	number of patients with overall positive surgical margins	postoperative assessment of positive surgical margins	immediate postoperative period
Secondary	biochemical recurrence rate		until the completion of the study, with a mean follow-up of 72 months