ProVee Urethral Expander System IDE Study (ProVIDE)

NCT05186740 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 221
• Locations: 3 countries
• Sites: 16

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).

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Keywords

BPH / LUTS

Outcome Measures

Primary Outcomes (4)

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

  This includes the rate of device or procedure related serious adverse events through 12-months.

  Procedure - 12 months

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

  The rate of extended post-operative urinary catheterization for inability to void among patients treated with the ProVee device.

  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)

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

  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

Study Arms (3)

Device: The ProVee Urethral Expander System

ACTIVE COMPARATOR

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

Sham: Ureteroscope and urethral access sheath

SHAM COMPARATOR

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

Crossover ProVee Urethral Expander System

OTHER

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

Interventions

ProVee Urethral Expander System DEVICE

ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.

Also known as: ProVee Expander, ProVee

Crossover ProVee Urethral Expander System; Device: The ProVee Urethral Expander System

Urethral Access Sheath PROCEDURE

The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.

Sham: Ureteroscope and urethral access sheath

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 ≥ 3.75cm 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 \> 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, 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

Sponsors & Collaborators

• ProVerum Medical: lead

Study Sites (16)

Golden State Urology

Sacramento, California, 95823, United States

Location

Urological Research Network Corp

Hialeah, Florida, 33016, United States

Location

Advanced Urology Institute

Palm Coast, Florida, 32164, United States

Location

Tampa Urology LLC

Tampa, Florida, 33606, United States

Location

Avant Concierge Urology

Winter Garden, Florida, 34787, United States

Location

Comprehensive Urologic Care

Lake Barrington, Illinois, 60010, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Sheldon Freedman MD

Las Vegas, Nevada, 89144, United States

Location

Mount Sinai

New York, New York, 10011, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

Midtown Urology Assoc.

Austin, Texas, 78705, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

St James's Hospital

Dublin, Ireland

Location

Related Publications (1)

• Kaplan SA, Parekattil SJ, Wu NZ, Mazzarella B, Trotter M, Freedman S, Lawindy S, Bukkapatnam R, Schwartz BF, Jones B, Sethi P, Jalkut M, Liu JS, Elterman D, Gheiler E, Gonzalez RR, Kaminetsky J, Motola JA, Te A, Chapple C, Lerner L, Lynch T. 12-Month Outcomes From a Randomized, Sham-Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia. J Urol. 2026 Apr;215(4):421-430. doi: 10.1097/JU.0000000000004896. Epub 2025 Dec 15.

  PMID: 41396103 DERIVED

Related Links

• ProVerum Website

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

This Clinical Study Protocol and Statistical Analysis Plan has been redacted in accordance with the regulations at 42 CFR 11.48(a)(5). Note that the all cause mortality results, the CEC adjudicated that the death was related to a pre-existing condition. For the serious adverse events, no reported serious adverse events have been adjudicated by CEC as device or procedural related.

Results Point of Contact

• Title: Vice President, Clinical Affairs |
• Organization: ProVerum

diane@proverummedical.com

+1-720-472-1504|

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subject will have noise cancelling headphones on during the treatment. A drape will be placed preventing subjects from observing implant procedure. The follow-up clinic coordinator will not have access to enrolled subjects' medical records including the randomization scheme and treatment procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, randomized, double-blind, sham-controlled safety and effectiveness study

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 11, 2022
• Study Start: June 9, 2022
• Primary Completion: March 15, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 28, 2026
• Results First Posted: December 1, 2025

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (14); IE (1)