NCT06546865

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

Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) Technique vs 26 F Sheath HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Comparative Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Thunder Bay Regional Health Research Institute · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-04-16
• Primary completion: 2025-04-16
• Completion: 2025-04-16
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: Canada