SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

SOLTIVE™ Laser Enucleation for Treatment of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04826887
• Other study ID #: GU-EN-Solep-01
• Status: Enrolling by invitation
• Start date: April 29, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• BPH
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Other:
• SOLTIVE Thulium Laser
Use of SOLTIVE Thulium laser for HoLEP
• Standard of Care (Holmium Laser)
Use of Holmium laser for HoLEP

Locations

Country	Name	City	State
United States	University of Kansas Medcial Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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