Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostatic Median Lobe for the Treatment of Benign Prostatic Hyperplasia in Men With Prominent Median Lobe Desiring Preservation of Ejaculation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
- Status
- Terminated
- Last Updated
- last year
Overview
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 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.
Investigators
Don Neff, MD, FACS
Principle Investigator
University of Kansas Medical Center
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months.
Time Frame: Up to 12 months
To evaluate improvement of symptoms through the International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 12 months. The IPSS is an 8-question screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Scoring: 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic
Secondary Outcomes
- Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII).(Up to 12 months)
- Post-operative participant reported outcomes using International Index of Erectile Function (IIEF).(Up to 12 months)
- Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF).(Up to 12 months)
- Post-Operative measurement of Peak Urine Flow Rate (Qmax)(Up to 12 months)
- Post-Operative measurement of Post Void Residual (PVR)(Up to 12 months)