SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

University of Kansas

Status: Completed

Conditions: Benign Prostatic Hyperplasia; BPH

Treatments: Other: Standard of Care (Holmium Laser); Other: SOLTIVE Thulium Laser

Study type: Observational

Funder types: Other

Identifiers

NCT04826887

GU-EN-Solep-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 2 patient groups

Solep Arm

Description:

Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure

Treatment:

Other: SOLTIVE Thulium Laser

Control Arm

Description:

Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure

Treatment:

Other: Standard of Care (Holmium Laser)