Actively Recruiting
Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
Led by Thunder Bay Regional Health Research Institute · Updated on 2024-08-09
142
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged over 50 years at enrollment
- Referred to urology for refractory lower urinary tract symptoms due to BPH
- Failed medical treatment for BPH
- Prostate size greater than 80 ml on preoperative ultrasound
- International Prostate Symptom Score (IPSS) greater than 15, Quality of Life score at least 3, and maximum urine flow rate less than 15 ml/sec
- Provided written informed consent to participate
- Able to comply with study procedures
You will not qualify if you...
- Previous surgical treatment for BPH
- History of prostate cancer
- Prostate size less than 80 ml
- History of urethral stenosis or its treatment
- Known or suspected neurogenic bladder
- Active urinary tract infection until treated
- Any preexisting conditions that may interfere with the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Actively Recruiting
Research Team
R
Rabail Siddiqui
CONTACT
S
Shalyn Littlefield
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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