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Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT

NCT06546865 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-08-09

No results posted yet for this study

Summary

Holmium laser enucleation of the prostate (HoLEP) is routinely performed with 24F, 26F, and 28F laser scopes. Proponents of larger caliber scopes suggest that the larger scope size allows for improved visualization, hemostasis, and operative efficiencies. Proponents of a smaller scope diameter suggest that by eliminating the need for pre-HoLEP urethral dilation to accommodate a larger scope. It has also been proposed that a smaller caliber scope is less traumatic to the urethra resulting in lower rates of bladder neck contracture and urethral stricture disease. Currently, to our knowledge, there are no level one evaluation examining scope size 22F versus 26F sheath in laser enucleation outcomes. The aim of our study is to determine if a smaller diameter scope is associated with improved laser enucleation time, post-operative recovery, rates of same-day discharge, or increasing intra-operative or postoperative complication rates

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

22F Sheath Size

Participants in this group will have the 22F sheath size used in their procedure.

DEVICE

26F Sheath Size

Participants in this group will have the 26F sheath size used in their procedure.

Sponsors & Collaborators

  • Thunder Bay Regional Health Research Institute

    lead OTHER

Principal Investigators

  • Hazem Elmansy · Thunder Bay Regional Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-16
Primary Completion
2025-04-16
Completion
2025-04-16

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06546865 on ClinicalTrials.gov