ProVee Urethral Expander System IDE Study (ProVIDE)

ProVerum Medical

Status: Active, not recruiting

Conditions: Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms

Treatments: Device: ProVee Urethral Expander System; Procedure: Urethral Access Sheath

Study type: Interventional

Funder types: Industry

Identifiers

NCT05186740

CIP-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 221 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males > 45 years of age
2. IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment
3. Prostate volume of ≥ 30 cc and ≤ 80 cc
4. Prostatic urethral L2 lengths ≥ 3.75cm by TRUS
5. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS

Exclusion criteria

1. Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml
2. 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''
3. High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
4. 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
5. Acute urinary retention
6. Known immunosuppression
7. History of or suspected prostate or bladder cancer
8. 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).
9. Recent urinary tract stones, OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure
10. A history of prostatitis within the last two years
11. Active or history of epididymitis within the past 3 months
12. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes'
13. History of urinary retention within 12 months of baseline assessment
14. Requiring self-catheterization to void
15. An active urinary tract infection (UTI) at time of index procedure
16. Gross haematuria, within 3 months of index procedure
17. Subjects with known allergy to nickel or titanium
18. Life expectancy estimated to be less than 60 months
19. Taking androgens, unless eugonadal state for at least 3 months or greater with a stable dosage for at least 2 months as documented by the Investigator
20. Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment
21. Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment
22. Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment
23. Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment
24. Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment unless there is documented evidence that the patient was on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study)
25. Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment
26. Use of beta-blockers where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last 6 months)
27. Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment
28. Current treatment with anticoagulants (e.g., warfarin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patient unable to stop taking antiplatelet and/or antiplatelets within 3 days prior to the procedure or warfarin at least 5 days prior to the procedure. Low dose aspirin ≤100mg/day not prohibited
29. Future fertility concerns
30. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants
31. Previous pelvic irradiation or radical pelvic surgery
32. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease
33. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
34. Urethral pathologies that may prevent insertion of Delivery System
35. Uncontrolled diabetes mellitus including Hgb AIC >8%
36. Overactive bladder (OAB) requiring treatment by OAB medication
37. Urinary incontinence
38. Patients taking tri-cyclic antidepressants.
39. Compromised renal function (i.e., serum creatinine >1.8 mg/dl or upper tract disease)
40. Hepatic disorder, bleeding disorders or metabolic impairment that might confound the results of the study or have a risk to subject per investigator's opinion
41. 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
42. Vulnerable populations such as incarcerated or institutionalized adults, inmates, patients with physical, psychological (such as developmentally delayed adults), or medical impairment that might, in the judgment of the Investigator, prevent study completion or comprehension, or may confound study results (including patient questionnaires)
43. History or current medical condition that would result in an unacceptable patient risk if that subject were to be included in the study
44. Any subject that is currently enrolled in another ongoing investigational study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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221 participants in 3 patient groups

Device: The ProVee Urethral Expander System

Active Comparator group

Description:

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.

Treatment:

Device: ProVee Urethral Expander System

Sham: Ureteroscope and urethral access sheath

Sham Comparator group

Description:

An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.

Treatment:

Procedure: Urethral Access Sheath

Crossover ProVee Urethral Expander System

Other group

Description:

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.

Treatment:

Device: ProVee Urethral Expander System