Recruiting

HoLEP vs. HoLEP

Sponsor:

Thunder Bay Regional Health Research Institute

Code:

NCT06546865

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

22F Sheath Size

26F Sheath Size

Study Details

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

Conditions

Benign Prostatic Hyperplasia

Study ID

NCT06546865

Start date

Apr 16, 2024

Status verified date

Aug, 2024

Completion date

Apr 16, 2025

Anticipated

Primary completion date

Apr 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 22F Sheath Size

Comparator arm for procedures using 22F sheath size

active comparator: 26F Sheath Size

Comparator arm for procedures using 26F sheath size

Interventions

22F Sheath Size

Participants in this group will have the 22F sheath size used in their procedure.

26F Sheath Size

Participants in this group will have the 26F sheath size used in their procedure.

Primary outcome measure

  • Comparison of Operating Time [ Time Frame: Intra-op ]

Central Contacts and Locations

Locations

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Principal Investigator:

Hazem Elmansy

More Information

Sponsor

Thunder Bay Regional Health Research Institute

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thunder Bay Regional Health Research Institute on 2024-08-09.