IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation
Purpose
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.
Condition
- Benign Prostatic Hyperplasia
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 preservation of ejaculatory function 4. Prominent median lobe with at least grade I intravesical protrusion of median lobe visualized on pre-operative cystoscopy
Exclusion Criteria
- Patients with baseline erectile and ejaculatory dysfunction as determined by a baseline 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 on pre-operative cystoscopy 5. Patients who are enrolled in other surgical or interventional trials at the time of this study are not eligible.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Simultaneous UroLift™ and HoLEP | UroLift System |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- University of Kansas Medical Center
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 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.