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Veil Preserving HoLEP vs. Stanadard HoLEP

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03494049
Acronym
MansprostIV
Enrollment
180
Registered
2018-04-11
Start date
2016-04-22
Completion date
2021-12-12
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Prostatectomy Incontinence

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.

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.

Interventions

PROCEDUREVeil sparring HoLEP

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.

PROCEDUREStandard HoLEP

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
urine incontinence1 month postoperativeone hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence

Secondary

MeasureTime frameDescription
international prostate symptom score1 yearSymptoms core assessment, score from 0 to 35, the higher the worse the urinary symptoms
urine flow rate1 yearrate of urine flow per unit time, how many milliliters of urine passed per second, above 15ml/second is normal
urine incontinence4 months postoperativeone hour pad test for post prostatectomy incontinence, scale from 0 to 4, the higher the more incontinence
International Consultation on Incontinence Questionnaire Short-Formone month postoperativeContinence core assessment, score from 0 to 21, the higher the worse the urinary continence

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026