Status:
RECRUITING
Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
Lead Sponsor:
Thunder Bay Regional Health Research Institute
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Previous surgical treatment for BPH
- History of prostate cancer
- Prostate size \< 80 mL
- History of urethral stenosis or its management
- Known or suspected neurogenic bladder
- Participants with active urinary tract infection until appropriately treated
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 16 2025
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06546865
Start Date
April 16 2024
End Date
April 16 2025
Last Update
August 9 2024
Active Locations (1)
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1
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4