Clinical trial NCT06546865: Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) vs 26 F Sheath HoLEP for BPH: RCT
Official title: Slim Sheath 22F Holmium Laser Enucleation of the Prostate (HoLEP) Technique vs 26 F Sheath HoLEP for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Thunder Bay Regional Health Research Institute
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 142
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Operating Time
timeFrame: Intra-op
Secondary outcomes:
measure: Time to Catheter Removal
timeFrame: Within 6 hours of procedure completion
measure: Length of Hospital Stay
timeFrame: Within 6 hours of procedure completion
measure: Continence status
timeFrame: One year post-procedure
measure: International Prostate Symptom Score
timeFrame: One year post-procedure
measure: Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)
timeFrame: One year post-procedure
measure: Peak flow rate
timeFrame: One year post-procedure
measure: Post-void residual
timeFrame: One year post-procedure
measure: Rate of Complications
timeFrame: One year post-procedure
Other outcomes:
Locations:
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
Study officials:
affiliation: Thunder Bay Regional Health Sciences Centre
name: Hazem Elmansy
role: PRINCIPAL_INVESTIGATOR
References: