Health TrialsbyHealthPanel

Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate

ConditionsBPH With Symptomatic Lower Urinary Tract SymptomsBPH With Urinary Obstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSmita De

About this trial

Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • holmium laser

    Device

    Prostate enucleation will holmium laser (control)

  • pulsed thulium laser

    Device

    experimental group - pulsed thulium laser prostate enucleation

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control - HolmiumActive comparator 1 intervention
Group B: Experimental - ThulioExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hemostasis time

time required to get adequate hemostasis intraoperatively

Time frame
During surgery

Secondary outcomes

1

Blood Loss

Estimated blood loss (mL)

Time frame
During surgery
2

Blood Loss

Change in hemoglobin (delta g/dL)

Time frame
During surgery
3

Operative parameters

Enucleation time (minutes)

Time frame
During surgery
4

Operative parameters

morcellation time (minutes)

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Smita De

Lead sponsor

The Cleveland Clinic

Sponsor institution

Source ClinicalTrials.gov
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