SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

University of Kansas Medical Center15 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

BPH Benign Prostatic Hyperplasia

Interventions

SOLTIVE Thulium LaserOTHER

Use of SOLTIVE Thulium laser for HoLEP

Standard of Care (Holmium Laser)OTHER

Use of Holmium laser for HoLEP

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients must be 18 years of age or older 2. Patients must be diagnosed with benign prostatic hyperplasia 3. Patients must opt for surgical management of their BPH with laser enucleation Exclusion Criteria: 1. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy) 2. Patients with prostate glands greater or equal to 200 grams 3. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.

Locations (1)

University of Kansas Medcial Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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).

Time frame: up to 1 year

Secondary Outcomes

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

Time frame: 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)

Time frame: up to 2 years

Data from ClinicalTrials.gov

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