MansprostIV: Veil Preserving HoLEP vs. Stanadard HoLEP

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03494049
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 67.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Prostatectomy Incontinence	Procedure: Veil sparring HoLEP; Procedure: Standard HoLEP	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
• Actual Study Start Date: Apr 22, 2016
• Actual Primary Completion Date: Dec 8, 2020
• Actual Study Completion Date: Dec 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. urine incontinence [1 month postoperative]

   one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence

Secondary Outcome Measures

1. international prostate symptom score [1 year]

   Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms

2. urine flow rate [1 year]

   rate of urine flow per unit time, how many milliliters of urine passed per second, above 15ml/second is normal

3. urine incontinence [4 months postoperative]

   one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and nephrology center	Mansoura	DK	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Ahmed Elshal, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Elshal, Principal Investigator, Mansoura University
• ClinicalTrials.gov Identifier: NCT03494049
• Other Study ID Numbers: Mans 1.2017
• First Posted: Apr 11, 2018
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 19, 2022