Veil Preserving HoLEP vs. Stanadard HoLEP

Post Prostatectomy Incontinence Clinical Trial

— MansprostIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494049
• Other study ID #: RP.19.11.49
• Status: Completed
• Phase: N/A
• Start date: April 22, 2016
• Est. completion date: December 12, 2021

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 12, 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Prostatectomy Incontinence

Intervention

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.
• Standard HoLEP
Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010

Locations

Country	Name	City	State
Egypt	Urology and nephrology center	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine incontinence	one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence	1 month postoperative
Secondary	international prostate symptom score	Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms	1 year
Secondary	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
Secondary	urine incontinence	one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence	4 months postoperative
Secondary	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