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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 Basketâ„¢" mode or MOSESâ„¢ mode) holmium lasers as well as the thulium fiber laser.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - Holmium | Active Comparator | Holmium laser enucleation |
|
| Experimental - Thulio | Experimental | Thulio laser enucleation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| holmium laser | Device | Prostate enucleation will holmium laser (control) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis time | time required to get adequate hemostasis intraoperatively | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Loss | Estimated blood loss (mL) | During surgery |
| Blood Loss | Change in hemoglobin (delta g/dL) | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iva Markovic | Contact | 216-636-9694 | markovi@ccf.org | |
| Smita De, MD, PHD | Contact | 216-445-4818 | des@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Main | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 28, 2025 | Sep 5, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| pulsed thulium laser |
| Device |
experimental group - pulsed thulium laser prostate enucleation |
|
| Operative parameters | Enucleation time (minutes) | During surgery |
| Operative parameters | morcellation time (minutes) | During surgery |
| Operative parameters | enucleation efficiency (mL prostate) | During surgery |
| Laser parameters | Laser time (minutes) | During surgery |
| Laser parameters | laser energy (joules) | During surgery |
| Laser parameters | Fiber burn-back (cm) | During surgery |
| Subjective laser performance | Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum) | During surgery |
| Perioperative outcomes | volume of tissue removed (mL) | 0-5 days after surgey |
| Perioperative outcomes | catheter time (hours) | 0-5 days after surgery |
| Perioperative outcomes | length of stay (hours) | 0-5 days after surgery |
| Perioperative outcomes | operative complications | 30 days post op |