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

Thunder Bay Regional Health Research Institute142 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

142

Conditions

Benign Prostatic Hyperplasia

Interventions

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Comparison of Operating Time

Operating time as measured during the procedure measured in minutes.

Time frame: Intra-op

Secondary Outcomes

Time to Catheter Removal

Time from end of procedure to the removal of catheter measured in minutes.

Time frame: Within 6 hours of procedure completion

Length of Hospital Stay

Time from end of procedure to participant discharge from the hospital in minutes.

Time frame: Within 6 hours of procedure completion

Continence status

Self-report from the participant on their continence.