Thulio versus Holmium lasers for removing enlarged prostate tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic Main
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Iva Markovic
• Email: markovi@ccf.org
• Phone: 216-636-9694

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.