Veil Preserving HoLEP vs. Stanadard HoLEP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Prostatectomy Incontinence

Intervention / Treatment
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* Procedure: Veil sparring HoLEP
* Procedure: Standard HoLEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' age ≥50 years ASA (American society of anesthesiologists) score ≤3. TRUS estimated weight ≥40 grams. Exclusion criteria: Patients who have any of the following were excluded: Patient with neurological disorder which might affect bladder function as cerebrovascular stroke or Parkinson disease. Active urinary tract infection. Presence of bladder cancer (within the last 2 years). Prostate cancer patients. Patients with bleeding tendency, ongoing anticoagulants or antiplatelet medications Previous prostate surgery

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Veil sparring HoLEP<br>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<br>* 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.<br>* Other names: early apical separation;|
| Active Comparator: Standard HoLEP<br>Standard HoLEP TECHNIQUE as described by Elhilali et al 2010 | Procedure: Standard HoLEP<br>* Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010<br>|

What is the study measuring?
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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 |