Actively Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
Led by Smita De · Updated on 2025-09-22
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating laser enucleation techniques for treating benign prostatic hyperplasia (BPH), focusing on comparing a new pulsed thulium laser (Thulio) with the established holmium laser enucleation of the prostate (HoLEP). These methods are considered size-independent and recommended by the American Urological Association due to favorable outcomes and fewer complications compared to older procedures. The study aims to assess differences in surgical outcomes and safety between these laser technologies. Participants will be randomly assigned to receive either the holmium laser or the pulsed thulium laser for prostate enucleation. The procedure involves removing prostate tissue using these laser devices during surgery. The study includes one follow-up evaluation after the procedure to monitor recovery and effectiveness. Both groups will be compared on various surgical and postoperative parameters. Throughout the study, participants will be assessed before surgery and once after surgery for outcomes such as hemostasis time during surgery, blood loss, operative and laser parameters, symptom scores, quality of life, urine flow tests, and catheterization duration. Researchers will monitor safety and recovery up to 30 days post-operation. The total involvement includes the surgical procedure and one follow-up visit to evaluate results and any complications.
CONDITIONS
Brief Title
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign an informed consent form
- Male patients with a prostate, at least 18 years of age
- No prior prostate surgery
You will not qualify if you...
- Unable or refuse to provide informed consent
- Prior prostate surgery
- Bladder stones requiring laser treatment (small stones removable whole are allowed)
- Unable to stop anticoagulants or antiplatelet medications as required before surgery and up to one week after surgery per standard protocols for surgery and post-operation care
- Female gender (not eligible as study includes only males with prostate)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 0 to 5 days after surgery
Participants undergo prostate enucleation using either the Holmium laser or the experimental Thulio laser, followed by immediate post-operative monitoring.
1 surgery visit and several post-operative visits within 5 days
Duration - 30 days post operation
Participants are assessed for recovery and outcomes following surgery.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Main
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
I
Iva Markovic
S
Smita De, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here