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

Sponsor
Consorci Sanitari Integral (Other)
Overall Status
Completed
CT.gov ID
NCT04043637
Collaborator
(none)
120
Enrollment
83.5
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence
    Actual Study Start Date :
    Apr 23, 2012
    Actual Primary Completion Date :
    Dec 3, 2018
    Actual Study Completion Date :
    Apr 10, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. number of patients with overall positive surgical margins [immediate postoperative period]

      postoperative assessment of positive surgical margins

    3. biochemical recurrence rate [until the completion of the study, with a mean follow-up of 72 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Consorci Sanitari Integral

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Consorci Sanitari Integral
    ClinicalTrials.gov Identifier:
    NCT04043637
    Other Study ID Numbers:
    • 19/24
    First Posted:
    Aug 2, 2019
    Last Update Posted:
    Aug 6, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Urinary Incontinence

    Study Results

    No Results Posted as of Aug 6, 2019