Veil Preserving HoLEP vs. Stanadard HoLEP (MansprostIV)

Mansoura University

Status: Completed

Conditions: Post Prostatectomy Incontinence

Treatments: Procedure: Veil sparring HoLEP; Procedure: Standard HoLEP

Study type: Interventional

Funder types: Other

Identifiers

NCT03494049

RP.19.11.49

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Veil sparring HoLEP

Active Comparator group

Description:

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.

Treatment:

Procedure: Veil sparring HoLEP

Standard HoLEP

Active Comparator group

Description:

Standard HoLEP TECHNIQUE as described by Elhilali et al 2010

Treatment:

Procedure: Standard HoLEP