ProVee Urethral Expander System IDE Study (ProVIDE)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH).

Detailed Description
-----------------
This is a prospective, multi-center, randomized, single-blind, sham-controlled study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH). Subjects are assigned to their treatment arm using an unbalanced (2 ProVee:1 Sham) randomization stratified by Investigational Sites.

Official Title
-----------------
The ProVee Urethral Expander System Clinical Study

Conditions
-----------------
Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Device: ProVee Urethral Expander System
* Procedure: Urethral Access Sheath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males > 45 years of age IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment Prostate volume of ≥ 30 cc and ≤ 80 cc Prostatic urethral L2 lengths ≥ 3.75cm by TRUS Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS Exclusion Criteria: Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml Obstructive median lobe defined by EITHER (>10mm protrusion on sagittal mid-prostate plane as measured by TRUS) OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve'' High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible Acute urinary retention Known immunosuppression History of or suspected prostate or bladder cancer Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated). Recent urinary tract stones, OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure A history of prostatitis within the last two years Active or history of epididymitis within the past 3 months Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident History of urinary retention within 12 months of baseline assessment Requiring self-catheterization to void An active urinary tract infection (UTI) at time of index procedure Gross haematuria, within 3 months of index procedure, haematuria Subjects with known allergy to nickel or titanium Life expectancy estimated to be less than 60 months Use of estrogen, drug-producing androgen suppression, or anabolic steroids (topical/ nasal acceptable) within 1 year of baseline assessment Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment Use of gonadotropin-releasing hormonal analogues, within 2 months of baseline assessment Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment Use of beta-blockers where the dose is not stable Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment Current treatment with anticoagulants (e.g., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA) where subject is unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin at least 5 days prior to the procedure Future fertility concerns Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants Previous pelvic irradiation or radical pelvic surgery Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology Urethral pathologies that may prevent insertion of Delivery System Uncontrolled diabetes mellitus including Hgb AIC >8% Overactive bladder (OAB) requiring treatment by OAB medication Urinary incontinence Serum creatinine >1.8 mg/dl or upper tract disease) Hepatic disorder, bleeding disorders or metabolic impairment Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 <50, renal illness that might prevent study completion or would confound study results Vulnerable populations including institutionalized adults, adults with impaired consent capacity including those with physical, psychological, or medical impairment, prisoners or others who are unable to fully comprehend the study requirements will be excluded from the clinical trial. subjects taking tri-cyclic antidepressants

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multi-center, randomized, double-blind, sham-controlled safety and effectiveness study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device: The ProVee Urethral Expander System<br>The ProVee Urethral Expander System consists of two components: a nitinol Expander implant and a 19Fr Delivery System designed to allow the Expander to be deployed under direct vision for the treatment arm. | Device: ProVee Urethral Expander System<br>* ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.<br>* Other names: ProVee;|
| Sham Comparator: Sham: Ureteroscope and urethral access sheath<br>An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure. | Procedure: Urethral Access Sheath<br>* The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.<br>|
| Other: Crossover ProVee Urethral Expander System<br>All subjects shall be unblinded following the 3 month follow-up visit. Those subjects randomized to the Sham Arm will be given the opportunity to crossover to the ProVee Urethral Expander System. | Device: ProVee Urethral Expander System<br>* ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.<br>* Other names: ProVee;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Device or Procedure Related Serious Adverse Events | Rate of device or procedure related serious adverse events | Procedure - 12 months | 
| Safety: Need for urinary catheterization | The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device. | > 7 days from treatment - 12 months | 
| Effectiveness: Reduction in BPH Symptoms compared to Sham | The ProVee Treatment Group will be considered superior to the Sham Treatment Group when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Sham Treatment Group alone. | Procedure to 3 months | 
| Effectiveness: Symptoms Improvement | The mean percent change in IPSS in the treatment arm is at least 30% improvement over the patient's pre-treatment baseline score. | Procedure to 12 months | 

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