NCT06546865 Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
| NCT ID | NCT06546865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thunder Bay Regional Health Research Institute |
| Condition | Benign Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2025-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2024-04-16 with a primary completion date of 2025-04-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Males over 50 years of age at the time of enrollment 2. Referred to urology for refractory LUTS secondary to BPH 3. Failed medical (non-surgical) treatment 4. Prostate size on preoperative TRUS of \> 80 ml 5. IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec 6. Written informed consent to participate in the study 7. Ability to comply with the requirements of the study procedures Exclusion Criteria: 1. Previous surgical treatment for BPH 2. History of prostate cancer 3. Prostate size \< 80 mL 4. History of urethral stenosis or its management 5. Known or suspected neurogenic bladder 6. Participants with active urinary tract infection until appropriately treated 7. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
Contact & Investigator
Hazem Elmansy
PRINCIPAL INVESTIGATOR
Thunder Bay Regional Health Sciences Centre
Frequently Asked Questions
Who can join the NCT06546865 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Benign Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06546865 currently recruiting?
Yes, NCT06546865 is actively recruiting participants. Contact the research team at rabail.siddiqui@tbh.net for enrollment information.
Where is the NCT06546865 trial being conducted?
This trial is being conducted at Thunder Bay, Canada.
Who is sponsoring the NCT06546865 clinical trial?
NCT06546865 is sponsored by Thunder Bay Regional Health Research Institute. The principal investigator is Hazem Elmansy at Thunder Bay Regional Health Sciences Centre. The trial plans to enroll 142 participants.