SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Completed

• Conditions: BPH; Benign Prostatic Hyperplasia
• Interventions: Other: Standard of Care (Holmium Laser); Other: SOLTIVE Thulium Laser

• Registration Number: NCT04826887
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-14
• Primary Completion: 2022-11-30
• Study Completion: 2024-05-02
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Arm	Standard of Care (Holmium Laser)	Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure
Solep Arm	SOLTIVE Thulium Laser	Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure

Primary Outcome Measures

Name	Time	Method
Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP	up to 1 year	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medcial Center; 🇺🇸 Kansas City, Kansas, United States