Active — Not RecruitingNot Applicable

ProVee Urethral Expander System IDE Study (ProVIDE)

United States221 participantsStarted 2022-06-09

Plain-language 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).

Who can participate

Age range45 Years

SexMALE

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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).

What they're measuring

Safety: Adverse Events (Time Frame: Procedure to 12 Months)

Timeframe: Procedure - 12 months

Safety: Number of Participants With Need for Urinary Catheterization (Time Frame: >7 Days Post Procedure)

Timeframe: 7 days post treatment through to 12 months

Effectiveness: Number of Participants With Reduction in BPH Symptoms Compared to Sham (Time Frame: Procedure to 3 Months)

Timeframe: Procedure to 3 months

Effectiveness: Number of Participants With Symptoms Improvements (Time Frame: Procedure to 12 Months)

Timeframe: Procedure to 12 months

Trial details

NCT IDNCT05186740

SponsorProVerum Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-15

Results submitted2025-07-30

View on ClinicalTrials.gov More BPH With Symptomatic Lower Urinary Tract Symptoms trials