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OpenTrials
Completed

NCT Number: NCT03494049

Veil Preserving HoLEP vs. Stanadard HoLEP

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.

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Key information

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veil sparring HoLEP

Procedure

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.

Other names: early apical separation

Standard HoLEP

Procedure

Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010

Primary outcomes

  1. urine incontinence

    Time frame: 1 month postoperative

    one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence

Secondary outcomes

  1. international prostate symptom score

    Time frame: 1 year

    Symptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms

  2. urine flow rate

    Time frame: 1 year

    rate of urine flow per unit time, how many milliliters of urine passed per second, above 15ml/second is normal

  3. urine incontinence

    Time frame: 4 months postoperative

    one hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence

  4. International Consultation on Incontinence Questionnaire Short-Form

    Time frame: one month postoperative

    Continence core assessment, score from 0 to 21, the higher the worse the urinary continence

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: MansprostIV

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 11, 2018
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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