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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• Males over 50 years of age at the time of enrollment

• Referred to urology for refractory LUTS secondary to BPH

• Failed medical (non-surgical) treatment

• Prostate size on preoperative TRUS of \> 80 ml

• IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec

• Written informed consent to participate in the study

• Ability to comply with the requirements of the study procedures

Locations
Other Locations
Canada
Thunder Bay Regional Health Sciences Centre
RECRUITING
Thunder Bay
Contact Information
Primary
Rabail Siddiqui
rabail.siddiqui@tbh.net
(807) 684-6000
Backup
Shalyn Littlefield
shalyn.littlefield@tbh.net
(807) 684-6000
Time Frame
Start Date: 2024-04-16
Estimated Completion Date: 2025-04-16
Participants
Target number of participants: 142
Treatments
Active_comparator: 22F Sheath Size
Comparator arm for procedures using 22F sheath size
Active_comparator: 26F Sheath Size
Comparator arm for procedures using 26F sheath size
Sponsors
Leads: Thunder Bay Regional Health Research Institute

This content was sourced from clinicaltrials.gov