Veil Preserving HoLEP vs. Stanadard HoLEP (MansprostIV)

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

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.

Study Overview

• Status: Completed
• Conditions: Post Prostatectomy Incontinence
• Intervention / Treatment: Procedure: Veil sparring HoLEP; Procedure: Standard HoLEP

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients' age ≥50 years
2. ASA (American society of anesthesiologists) score ≤3.
3. TRUS estimated weight ≥40 grams.

Exclusion criteria:

Patients who have any of the following were excluded:

1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease.
2. Active urinary tract infection.
3. Presence of bladder cancer (within the last 2 years).
4. Prostate cancer patients.
5. Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications
6. Previous prostate surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Veil sparring HoLEP; Early mucosal incision lateral to the Veru 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.	Procedure: Veil sparring HoLEP; Early 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.; Other Names: early apical separation
Active Comparator: Standard HoLEP; Standard HoLEP TECHNIQUE as described by Elhilali et al 2010	Procedure: Standard HoLEP; Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine incontinence	one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence	1 month postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
international prostate symptom score	Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms	1 year
urine flow rate	rate of urine flow per unit time, how many milliliters of urine passed per second, above 15ml/second is normal	1 year
urine incontinence	one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence	4 months postoperative
International Consultation on Incontinence Questionnaire Short-Form	Continence core assessment, score from 0 to 21, the higher the worse the urinary continence	one month postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmed Elshal, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2016
• Primary Completion (Actual): December 8, 2020
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: March 31, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RP.19.11.49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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