Comparing Thulium Fiber Laser and Holmium MOSES for treating enlarged prostate
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study
This study is testing if a new Thulium Fiber Laser treatment can help men over 50 with enlarged prostates feel better compared to the existing Holmium laser method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (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 | NCT05240001 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Thulium Fiber Laser (TFL) compared to Holmium MOSES laser for treating benign prostatic hyperplasia (BPH). BPH causes urinary issues due to prostate enlargement, and traditional treatments like TURP have significant risks. The trial aims to determine if TFL can provide a safer and more efficient alternative to the Holmium laser technique, which is already recognized for its benefits but is complex to perform. Participants will be men over 50 who have not responded to medical treatments for BPH.
Who should consider this trial
Good fit: Ideal candidates are males over 50 with refractory lower urinary tract symptoms or urinary retention due to BPH who have failed medical treatment.
Not a fit: Patients with a history of prostate cancer or previous surgical treatment for BPH will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer and more effective treatment option for men suffering from BPH.
How similar studies have performed: Previous studies have shown that laser treatments like HoLEP can be effective, suggesting potential success for this novel approach with TFL.
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 or urinary retention secondary to BPH 3. Failed medical (non-surgical) treatment 4. Prostate size on preoperative TRUS of≥80 ml 5. IPSS \>15 and 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 8. Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent
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, MD — Thunder Bay Regional Health Sciences Centre
- Study coordinator: Rabail Siddiqui, MPH, MHSc
- Email: siddiqur@tbh.net
- Phone: (807) 684-6608
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.