IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

Last updated: April 1, 2025
Sponsor: University of Kansas Medical Center
Overall Status: Terminated

Phase

N/A

Condition

Bladder Disorders

Prostate Disorders

Treatment

UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)

Clinical Study ID

NCT06157164
HSC 149327
  • Ages > 45
  • Male

Study Summary

To evaluate postoperative outcomes of BPH/Lower urinary tract symptoms, erectile function, and ejaculatory capacity of simultaneous UroLiftTM and Holmium laser enucleation of the prostatic median lobe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be 45 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 desire for preservationof ejaculatory function

  4. Prominent median lobe with at least grade I intravesical protrusion of median lobevisualized on pre-operative cystoscopy

Exclusion

Exclusion Criteria:

  1. Patients with baseline erectile and ejaculatory dysfunction as determined by abaseline IIEF-5 score < 15

  2. Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS,cerebral palsy)

  3. Patients with prostate glands greater or equal to 100 grams

  4. Patients with less than a grade I intravesical protrusion of median lobe onpre-operative cystoscopy

  5. Patients who are enrolled in other surgical or interventional trials at the time ofthis study are not eligible.

Study Design

Total Participants: 3
Treatment Group(s): 1
Primary Treatment: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)
Phase:
Study Start date:
February 06, 2023
Estimated Completion Date:
January 14, 2025

Study Description

Preserving ejaculation is a significant factor that impacts patient's decisions regarding what proceeding with treatment of BPH symptoms. The UroLiftTM system provides a safe procedure that has proven preservation of ejaculatory function. However, it is contraindicated in patients with prominent median lobes. The combination with laser median lobe enucleation may provide the same improvement in symptoms and widen patient inclusion criteria to those desire preserved ejaculation that also have a prominent median lobe.

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

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