NCT03494049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2021

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.6 years

First QC Date

March 31, 2018

Last Update Submit

June 13, 2023

Conditions

Post Prostatectomy Incontinence

Outcome Measures

Primary Outcomes (1)

  • urine incontinence

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

    1 month postoperative

Secondary Outcomes (4)

  • international prostate symptom score

    1 year

  • urine flow rate

    1 year

  • urine incontinence

    4 months postoperative

  • International Consultation on Incontinence Questionnaire Short-Form

    one month postoperative

Study Arms (2)

Veil sparring HoLEP

ACTIVE COMPARATOR

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.

Procedure: Veil sparring HoLEP

Standard HoLEP

ACTIVE COMPARATOR

Standard HoLEP TECHNIQUE as described by Elhilali et al 2010

Procedure: Standard HoLEP

Interventions

Veil sparring HoLEPPROCEDURE

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.

Also known as: early apical separation
Veil sparring HoLEP
Standard HoLEPPROCEDURE

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

Standard HoLEP

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsprostate surgeries
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' age ≥50 years
  • ASA (American society of anesthesiologists) score ≤3.
  • TRUS estimated weight ≥40 grams.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

Location

Study Officials

  • Ahmed Elshal

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2018

First Posted

April 11, 2018

Study Start

April 22, 2016

Primary Completion

December 8, 2020

Study Completion

December 12, 2021

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)