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OpenTrials
Completed

NCT Number: NCT04826887

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

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Key information

Conditions

BPH Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Kansas Medcial Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

SOLTIVE Thulium Laser

Other

Use of SOLTIVE Thulium laser for HoLEP

Standard of Care (Holmium Laser)

Other

Use of Holmium laser for HoLEP

Primary outcomes

  1. Comparing the SOLTIVE Thulium Fiber to the Holmium Laser for HoLEP

    Time frame: 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 outcomes

  1. Compare intraoperative components between the two surgical approaches

    Time frame: 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

  2. Compare post-operative outcomes of the two surgical approaches

    Time frame: up to 2 years

    To compare post-operative components of SOLTIVE Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Apr 1, 2021
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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