IIT-2022-Simultaneous Urolift™ and Median Lobe Enucleation

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simultaneous UroLift™ and HoLEP<br>UroLift System | Other: UroLift™ System and Holmium Laser Enucleation of the Prostate (HoLEP)<br>* Simultaneous UroLift™ and Holmium Laser Enucleation of the Prostate (HoLEP) for the Treatment of BPH in Men with Prominent Median Lobe Desiring Preservation of Ejaculation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) change (improvement) from baseline at 3 and 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 | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative participant reported outcomes using benign prostatic hyperplasia impact index (BPHII). | Evaluate post-operative participant reported outcomes using Benign Prostatic Hyperplasia Impact Index (BPHII). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority. | Up to 12 months | 
| Post-operative participant reported outcomes using International Index of Erectile Function (IIEF). | Evaluate post-operative sexual function using participant reported outcome International Index of Erectile Function (IIEF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority. | Up to 12 months | 
| Post-operative participant reported outcomes using Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). | Evaluate post-operative sexual function using participant reported outcome Male Sexual Health Questionnaire for Ejaculatory Dysfunction Short Form (MSHQ-EjD-SF). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority. | Up to 12 months | 
| Post-Operative measurement of Peak Urine Flow Rate (Qmax) | Evaluate post-operative lower urinary tract symptoms further with Peak Urine Flow Rate (Qmax). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority. | Up to 12 months | 
| Post-Operative measurement of Post Void Residual (PVR) | Evaluate post-operative lower urinary tract symptoms further with Post Void Residual (PVR). Post operative data will be compared to those values previously published for UroLift alone to evaluate non inferiority. | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH