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

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

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 Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: 22F Sheath Size; Device: 26F Sheath Size

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabail Siddiqui; Phone Number: (807) 684-6000; Email: rabail.siddiqui@tbh.net
• Study Contact Backup: Name: Shalyn Littlefield; Phone Number: (807) 684-6000; Email: shalyn.littlefield@tbh.net

Study Locations

• Canada
  • Ontario
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Recruiting
      • Thunder Bay Regional Health Sciences Centre
      • Contact: Rabail Siddiqui; Phone Number: (807) 684-6000; Email: rabail.siddiqui@tbh.net
      • Principal Investigator: Hazem Elmansy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22F Sheath Size; Comparator arm for procedures using 22F sheath size	Device: 22F Sheath Size; Participants in this group will have the 22F sheath size used in their procedure.
Active Comparator: 26F Sheath Size; Comparator arm for procedures using 26F sheath size	Device: 26F Sheath Size; Participants in this group will have the 26F sheath size used in their procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Operating Time	Operating time as measured during the procedure measured in minutes.	Intra-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Catheter Removal	Time from end of procedure to the removal of catheter measured in minutes.	Within 6 hours of procedure completion
Length of Hospital Stay	Time from end of procedure to participant discharge from the hospital in minutes.	Within 6 hours of procedure completion
Continence status	Self-report from the participant on their continence.	One year post-procedure
International Prostate Symptom Score	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.	One year post-procedure
Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)	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	One year post-procedure
Peak flow rate	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	One year post-procedure
Post-void residual	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	One year post-procedure
Rate of Complications	Occurrence of procedure-related complications	One year post-procedure

Collaborators and Investigators

• Sponsor: Thunder Bay Regional Health Research Institute
• Investigators: Principal Investigator: Hazem Elmansy, Thunder Bay Regional Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): April 16, 2025
• Study Completion (Estimated): April 16, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: RP-1064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No