Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
NCT Number: NCT06546865
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Benign Prostatic Hyperplasia
Interventions: DEVICE: 22F Sheath Size|DEVICE: 26F Sheath Size
Sponsor: Thunder Bay Regional Health Research Institute
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 142
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-16
Completion Date: 2025-04-16
Locations: Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada

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

Primary Outcome Measures: Comparison of Operating Time, Operating time as measured during the procedure measured in minutes., Intra-op
Secondary Outcome Measures: Time to Catheter Removal, Time from end of procedure to the removal of catheter measured in minutes., Within 6 hours of procedure completion|Length of Hospital Stay, Time from end of procedure to participant discharge from the hospital in minutes., Within 6 hours of procedure completion|Continence status, Self-report from the participant on their continence., One year post-procedure|International Prostate Symptom Score, Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35., One year post-procedure|Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS), Response to the last question on the IPSS:

"If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible, One year post-procedure|Peak flow rate, Measured as Qmax "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible, One year post-procedure|Post-void residual, PVR "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible, One year post-procedure|Rate of Complications, Occurrence of procedure-related complications, One year post-procedure