Clinical Trials Directory

Trials / Completed

CompletedNCT03494049

Veil Preserving HoLEP vs. Stanadard HoLEP

Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

Summary

Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly. In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring. Our hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if anny would be shortened.

Detailed description

Postoperative transient stress urine leakage following Holmium laser enucleation of the prostate is one of the problems that frustrate both surgeon and patients. Many reports addressed different variables for the cause of post HoLEP urine leakage. Looking for a procedure done by a single surgeon who had tremendous experience of this procedure may enable investigators to identify precisely technical points of interest that may affect post HoLEP stress urine incontinence. Standard HoLEP might be associated with some stretch of the sphincter and de-epithelization of the sphincter area anteriorly. In Veil preserving HoLEP, early separation of the adenoma from the sphincter ring minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring. Investigators' hypothesis is that by this technique the early postoperative transient urine leak would be minimized and duration of leakage if any would be shortened.

Conditions

Interventions

TypeNameDescription
PROCEDUREVeil sparring HoLEPEarly mucosal incision; lateral to the Veru and proximal to the apical bulge of the adenoma, followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch. Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring.
PROCEDUREStandard HoLEPHolmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010

Timeline

Start date
2016-04-22
Primary completion
2020-12-08
Completion
2021-12-12
First posted
2018-04-11
Last updated
2023-06-15

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03494049. Inclusion in this directory is not an endorsement.