SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

NCT04826887 | Completed

• 1 other identifier: GU-EN-Solep-01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

BPH; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compare intraoperative components between the two surgical approaches

  up to 1 year

• Compare post-operative outcomes of the two surgical approaches

  up to 2 years

Study Arms (2)

Solep Arm

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

Other: SOLTIVE Thulium Laser

Control Arm

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

Other: Standard of Care (Holmium Laser)

Interventions

SOLTIVE Thulium Laser OTHER

Use of SOLTIVE Thulium laser for HoLEP

Solep Arm

Standard of Care (Holmium Laser) OTHER

Use of Holmium laser for HoLEP

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is looking at benign prostatic hypeplasia (BPH) - therefore men are the only gender to enroll. Women do not have prostates
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medcial Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Standard of Care; Lasers, Solid-State

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Donald Neff

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: April 1, 2021
• Study Start: April 14, 2021
• Primary Completion: November 30, 2022
• Study Completion: May 2, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)