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

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.

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Key information

Conditions

Prostatic Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Surgical Procedure, Unspecified Urinary Incontinence Urination Disorders Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urological Manifestations

Age range

40 year–75 year

Sex eligibility

Male

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

change in the proportion of patients with of urinary incontinence

Time frame: 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 outcomes

change in the proportion of patients with recovery of the erectile function

Time frame: 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

Time frame: immediate postoperative period

postoperative assessment of positive surgical margins
biochemical recurrence rate

Time frame: until the completion of the study, with a mean follow-up of 72 months

Sponsors and collaborators

Lead sponsor

Consorci Sanitari Integral

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2019
First posted: Aug 2, 2019
Registry last updated: Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed