Comparing two sizes of laser scopes for prostate surgery
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
This study is testing whether using a smaller laser scope during prostate surgery helps men with enlarged prostates recover faster and have fewer complications compared to using a larger scope.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Thunder Bay Regional Health Research Institute Academic / other |
| Locations | 1 site (Thunder Bay, Ontario) |
| Trial ID | NCT06546865 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different sheath sizes (22F and 26F) used in Holmium laser enucleation of the prostate (HoLEP) for treating benign prostatic hyperplasia (BPH). The study aims to determine if the smaller 22F sheath leads to better outcomes in terms of laser enucleation time, post-operative recovery, and complication rates compared to the larger 26F sheath. By analyzing these factors, the trial seeks to provide insights into the optimal scope size for improved patient care in urology.
Who should consider this trial
Good fit: Ideal candidates are males over 50 years old with refractory lower urinary tract symptoms due to BPH who have not responded to medical treatment.
Not a fit: Patients with a history of prostate cancer or those who have previously undergone surgical treatment for BPH may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less traumatic surgical options for patients with BPH, resulting in quicker recovery times and fewer complications.
How similar studies have performed: There is currently no level one evaluation comparing the outcomes of 22F versus 26F sheath sizes in laser enucleation, making this a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Thunder Bay, Ontario
- Thunder Bay Regional Health Sciences Centre — Thunder Bay, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Hazem Elmansy — Thunder Bay Regional Health Sciences Centre
- Study coordinator: Rabail Siddiqui
- Email: rabail.siddiqui@tbh.net
- Phone: (807) 684-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.