Veil Preserving HoLEP vs. Stanadard HoLEP (MansprostIV)

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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