Benign Prostatic Hyperplasia, BPH
Conditions
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.
Interventions
OTHERSOLTIVE Thulium Laser
Use of SOLTIVE Thulium laser for HoLEP
OTHERStandard of Care (Holmium Laser)
Use of Holmium laser for HoLEP
Sponsors
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed