Veil Preserving HoLEP vs. Stanadard HoLEP
- Conditions
- Post Prostatectomy Incontinence
- Interventions
- Procedure: Standard HoLEPProcedure: Veil sparring HoLEP
- Registration Number
- NCT03494049
- Lead Sponsor
- Mansoura University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 180
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard HoLEP Standard HoLEP Standard HoLEP TECHNIQUE as described by Elhilali et al 2010 Veil sparring HoLEP 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
International Consultation on Incontinence Questionnaire Short-Form one month postoperative Continence core assessment, score from 0 to 21, the higher the worse the urinary continence
international prostate symptom score 1 year Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms
urine incontinence 4 months postoperative one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
Trial Locations
- Locations (1)
Urology and nephrology center
🇪🇬Mansoura, DK, Egypt