Thulio versus Holmium lasers for removing enlarged prostate tissue
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
This trial will test whether the new pulsed Thulio (thulium) laser works as well as the standard holmium laser for men with enlarged prostates and urinary symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07187180 on ClinicalTrials.gov |
What this trial studies
This is a prospective randomized comparison of pulsed thulium (Thulio) laser enucleation versus standard holmium laser enucleation for men undergoing prostate enucleation for BPH. Patients are randomized in equal numbers and evaluated before the procedure and at one follow-up visit. The primary endpoint is non-inferiority for hemostasis timing, and secondary endpoints include enucleation time, active laser time, morcellation time, change in hemoglobin, total applied laser energy, enucleation efficacy (g/min), IPSS, QoL, uroflowmetry, post-void residual, prostate volume, and catheter duration. The trial excludes men with prior prostate surgery, bladder stones requiring lasering, or those who cannot safely hold anticoagulants per protocol.
Who should consider this trial
Good fit: Men aged 18 or older with BPH causing urinary symptoms or obstruction, no prior prostate surgery, and who can temporarily stop anticoagulants per protocol are ideal candidates.
Not a fit: Patients with prior prostate surgery, bladder stones that require lasering, or those unable to safely pause anticoagulants are unlikely to qualify and may not receive benefit from this comparison.
Why it matters
Potential benefit: If Thulio is non-inferior or better, patients could experience similar or improved bleeding control and operative efficiency, potentially shortening surgery time and recovery.
How similar studies have performed: Holmium and thulium enucleation techniques are established with good outcomes, but randomized comparisons of pulsed thulium (Thulio) versus standard holmium lasers remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Understand and voluntarily sign an informed consent form. * Patients must be males with a prostate, at least 18 years of age * No prior prostate surgery Exclusion Criteria: * Unable/refuse to provide informed consent * Prior prostate surgery * Bladder stones that requiring lasering (small stone that can be removed whole is ok) * Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Main — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Iva Markovic
- Email: markovi@ccf.org
- Phone: 216-636-9694
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.