ProVIDE II Bridging Study

Running, not enrolling · Not applicable

Conditions studied: BPH With Symptomatic Lower Urinary Tract Symptoms

In brief

The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.

Key facts

Study ID

NCT06236802

Run by

ProVerum Medical

People needed

40

Starts

2024-03-06

Expected to finish

2029-06-01

Last updated by the study team

2026-07-09

Who can join

Age: 45 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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 ≥ 3.75 cm by TRUS
• Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

You may not qualify if…

• Void volume <125 ml; Qmax > 12 ml/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, diabetes
• 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.
• Subjects with known allergy to nickel or titanium
• Life expectancy estimated to be less than 60 months
• 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
• 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 estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment
• 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)
• Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment

Where it is running

• Florida Urology Partners, LLP — Tampa, Florida, United States
• Avant Concierge Urology — Winter Garden, Florida, United States
• Comprehensive Urologic Care — Lake Barrington, Illinois, United States
• Sheldon Freeman MD LTD — Las Vegas, Nevada, United States
• Midtown Urology Assoc. PA — Austin, Texas, United States
• Urology Austin — Austin, Texas, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• St James Hospital — Dublin, Ireland

Full record on ClinicalTrials.gov

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