SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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To compare intraoperative as well as postoperative outcomes of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate. Our hypothesis is that utilizing the SOLTIVE Thulium laser enucleation of the prostate will result in a more efficient procedure, comparable results to that of Holmium laser enucleation of the prostate and subjective improvement of prior device limitations

Detailed Description
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Thulium laser is continuous wave laser which offers numerous potential benefits compared to alternative lasers and surgical procedures used for BPH. The SOLTIVE Laser system is a compact system which is significantly smaller than Holmium laser systems. The laser fiber is also smaller in diameter allowing for improved maneuverability with decreased fiber degradation and endoscope damage. The continuous wave pattern produces fast, hemostatic cuts during the removal and furthermore the associated hemostasis improves the visual field. Additionally, based on the 1940nm wavelength is absorbed nearly five times more in water. For all the stated reasons, the SOLTIVE Thulium Laser should improve the enucleation efficiency and warrants further investigation.

Official Title
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SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Conditions
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BPH, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Other: SOLTIVE Thulium Laser
* Other: Standard of Care (Holmium Laser)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be 18 years of age or older Patients must be diagnosed with benign prostatic hyperplasia Patients must opt for surgical management of their BPH with laser enucleation Exclusion Criteria: Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy) Patients with prostate glands greater or equal to 200 grams Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solep Arm<br>Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure | Other: SOLTIVE Thulium Laser<br>* Use of SOLTIVE Thulium laser for HoLEP<br>|
| Control Arm<br>Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure | Other: Standard of Care (Holmium Laser)<br>* Use of Holmium laser for HoLEP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP | To evaluate SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) in comparison to Holmium Laser Enucleation of the Prostate through AUA Symptom Score. AUA Symptom score will be assessed using the Scale - Mild (under 7 cumulative score, moderate 8-19 score, and severe is a cumulative score over 20). | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare intraoperative components between the two surgical approaches | To compare intraoperative components of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) vs Holmium Laser Enucleation of the Prostate | up to 1 year | 
| Compare post-operative outcomes of the two surgical approaches | To compare post-operative components of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) | up to 2 years |