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

NCT06546865 | Recruiting

• 1 other identifier: RP-1064
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Comparison of Operating Time

  Operating time as measured during the procedure measured in minutes.

  Intra-op

Secondary Outcomes (8)

• Time to Catheter Removal

  Within 6 hours of procedure completion

• Length of Hospital Stay

  Within 6 hours of procedure completion

• Continence status

  One year post-procedure

• International Prostate Symptom Score

  One year post-procedure

• Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)

  One year post-procedure

Study Arms (2)

22F Sheath Size

ACTIVE COMPARATOR

Comparator arm for procedures using 22F sheath size

Device: 22F Sheath Size

26F Sheath Size

ACTIVE COMPARATOR

Comparator arm for procedures using 26F sheath size

Device: 26F Sheath Size

Interventions

22F Sheath Size DEVICE

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

22F Sheath Size

26F Sheath Size DEVICE

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

26F Sheath Size

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males over 50 years of age at the time of enrollment
• Referred to urology for refractory LUTS secondary to BPH
• Failed medical (non-surgical) treatment
• Prostate size on preoperative TRUS of \> 80 ml
• IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Previous surgical treatment for BPH
• History of prostate cancer
• Prostate size \< 80 mL
• History of urethral stenosis or its management
• Known or suspected neurogenic bladder
• Participants with active urinary tract infection until appropriately treated
• Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hazem Elmansy

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabail Siddiqui

CONTACT

(807) 684-6000; rabail.siddiqui@tbh.net

Shalyn Littlefield

CONTACT

(807) 684-6000; shalyn.littlefield@tbh.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: April 16, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)