SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; BPH
• Intervention / Treatment: Other: SOLTIVE Thulium Laser; Other: Standard of Care (Holmium Laser)

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medcial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will present to clinic for treatment of BPH assessment and evaluation per routine clinical care. Patients will be identified by clinical care team as an eligible candidate for study participation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Solep Arm; Use of SOLTIVE Thulium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure	Other: SOLTIVE Thulium Laser; Use of SOLTIVE Thulium laser for HoLEP
Control Arm; Use of Holmium Laser for HoLEP (Holmium Laser Enucleation of the Prostate) procedure	Other: Standard of Care (Holmium Laser); Use of Holmium laser for HoLEP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Donald Neff, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): May 2, 2024

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: GU-EN-Solep-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No