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NCT Number: NCT07187180

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

holmium laser

Device

Prostate enucleation will holmium laser (control)

pulsed thulium laser

Device

experimental group - pulsed thulium laser prostate enucleation

Primary outcomes

  1. Hemostasis time

    Time frame: During surgery

    time required to get adequate hemostasis intraoperatively

Secondary outcomes

  1. Blood Loss

    Time frame: During surgery

    Estimated blood loss (mL)

  2. Blood Loss

    Time frame: During surgery

    Change in hemoglobin (delta g/dL)

  3. Operative parameters

    Time frame: During surgery

    Enucleation time (minutes)

  4. Operative parameters

    Time frame: During surgery

    morcellation time (minutes)

  5. Operative parameters

    Time frame: During surgery

    enucleation efficiency (mL prostate)

  6. Laser parameters

    Time frame: During surgery

    Laser time (minutes)

  7. Laser parameters

    Time frame: During surgery

    laser energy (joules)

  8. Laser parameters

    Time frame: During surgery

    Fiber burn-back (cm)

  9. Subjective laser performance

    Time frame: During surgery

    Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum)

  10. Perioperative outcomes

    Time frame: 0-5 days after surgey

    volume of tissue removed (mL)

  11. Perioperative outcomes

    Time frame: 0-5 days after surgery

    catheter time (hours)

  12. Perioperative outcomes

    Time frame: 0-5 days after surgery

    length of stay (hours)

  13. Perioperative outcomes

    Time frame: 30 days post op

    operative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Iva Markovic

CONTACT

[email protected]

216-636-9694

Smita De, MD, PHD

CONTACT

[email protected]

216-445-4818

Sponsors and collaborators

Lead sponsor

Smita De

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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