Status:
TERMINATED
IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- Patients must be 45 years of age or older
- Patients must be diagnosed with benign prostatic hyperplasia
- Patients must opt for surgical management of their BPH with desire for preservation of ejaculatory function
- Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy
Exclusion
- Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline IIEF-5 score \< 15
- Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
- Patients with prostate glands greater or equal to 100 grams
- Patients with less than a grade I intravesical protrusion of median lobe on pre-operative cystoscopy
- Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
Key Trial Info
Start Date :
February 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT06157164
Start Date
February 6 2023
End Date
January 14 2025
Last Update
April 4 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160