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

Thunder Bay Regional Health Research Institute

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: 26F Sheath Size; Device: 22F Sheath Size

Study type: Interventional

Funder types: Other

Identifiers

NCT06546865

RP-1064

Details and patient eligibility

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

Enrollment: 142 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

22F Sheath Size

Active Comparator group

Description:

Comparator arm for procedures using 22F sheath size

Treatment:

Device: 22F Sheath Size

26F Sheath Size

Active Comparator group

Description:

Comparator arm for procedures using 26F sheath size

Treatment:

Device: 26F Sheath Size