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Veil Preserving HoLEP vs. Stanadard HoLEP (MansprostIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494049
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Elshal, Mansoura University

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.


Condition or disease Intervention/treatment Phase
Post Prostatectomy Incontinence Procedure: Veil sparring HoLEP Procedure: Standard HoLEP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Veil-preserving Versus Standard Holmium Laser Enucleation of the Prostate: Randomized Clinical Trial
Actual Study Start Date : April 22, 2016
Estimated Primary Completion Date : December 8, 2019
Estimated Study Completion Date : December 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Veil sparring HoLEP

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

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.


Active Comparator: Standard HoLEP
Standard HoLEP TECHNIQUE as described by Elhilali et al 2010
Procedure: Standard HoLEP
Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010




Primary Outcome Measures :
  1. stress 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


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   prostate surgeries
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494049


Contacts
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Contact: Ahmed Elshal, MD 0502202222 ext 1648 elshalam@hotmail.com

Locations
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Egypt
Urology and nephrology center Recruiting
Mansoura, DK, Egypt, 35516
Contact: Ahmed M Elshal, MD    +20502202222 ext 1643    elshalam@hotmail.com   
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Ahmed Elshal Mansoura University
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Responsible Party: Ahmed Elshal, Principal Investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT03494049    
Other Study ID Numbers: Mans 1.2017
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No