Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia

In brief

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

Key facts

Study ID

NCT06546865

Run by

Thunder Bay Regional Health Research Institute

People needed

142

Starts

2024-04-16

Expected to finish

2025-04-16

Last updated by the study team

2024-08-09

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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