Clinical trial NCT03494049: Veil Preserving HoLEP vs. Stanadard HoLEP
Official title: Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Prostatectomy Incontinence
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 180
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: urine incontinence
timeFrame: 1 month postoperative
Secondary outcomes:
measure: international prostate symptom score
timeFrame: 1 year
measure: urine flow rate
timeFrame: 1 year
measure: urine incontinence
timeFrame: 4 months postoperative
measure: International Consultation on Incontinence Questionnaire Short-Form
timeFrame: one month postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: DK
Study officials:
affiliation: Mansoura University
name: Ahmed Elshal
role: PRINCIPAL_INVESTIGATOR
References: