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

Not Applicable

Recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: 22F Sheath Size; Device: 26F Sheath Size

• Registration Number: NCT06546865
• Lead Sponsor: Thunder Bay Regional Health Research Institute

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-16
• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-04-16
• Study Completion: 2025-04-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 142

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
22F Sheath Size	22F Sheath Size	Comparator arm for procedures using 22F sheath size
26F Sheath Size	26F Sheath Size	Comparator arm for procedures using 26F sheath size

Primary Outcome Measures

Name	Time	Method
Comparison of Operating Time	Intra-op	Operating time as measured during the procedure measured in minutes.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)	One year post-procedure	Response to the last question on the IPSS: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible
Length of Hospital Stay	Within 6 hours of procedure completion	Time from end of procedure to participant discharge from the hospital in minutes.
Time to Catheter Removal	Within 6 hours of procedure completion	Time from end of procedure to the removal of catheter measured in minutes.
Continence status	One year post-procedure	Self-report from the participant on their continence.
International Prostate Symptom Score	One year post-procedure	Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35.
Rate of Complications	One year post-procedure	Occurrence of procedure-related complications
Peak flow rate	One year post-procedure	Measured as Qmax "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible
Post-void residual	One year post-procedure	PVR "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response ranging from 'Delighted' to 'Terrible

Trial Locations

Locations (1)

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada