ProVee Urethral Expander System IDE Study (ProVIDE) (ProVIDE)

July 10, 2026 updated by: ProVerum Medical

The ProVee Urethral Expander System Clinical Study

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
221

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network
  • Ireland
      • Dublin, Ireland
        • St James's Hospital
  • United States
    • California
      • Sacramento, California, United States, 95823
        • Golden State Urology
    • Florida
      • Hialeah, Florida, United States, 33016
        • Urological Research Network Corp
      • Palm Coast, Florida, United States, 32164
        • Advanced Urology Institute
      • Tampa, Florida, United States, 33606
        • Tampa Urology LLC
      • Winter Garden, Florida, United States, 34787
        • Avant Concierge Urology
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Comprehensive Urologic Care
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Sheldon Freedman MD
    • New York
      • New York, New York, United States, 10011
        • Mount Sinai
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Associated Urologists of North Carolina
    • Texas
      • Austin, Texas, United States, 78745
        • Urology Austin
      • Austin, Texas, United States, 78705
        • Midtown Urology Assoc.
      • Houston, Texas, United States, 77030
        • Houston Methodist
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Urology of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Device: The ProVee Urethral Expander System
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
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Other Names:
  • ProVee Expander
  • ProVee
Sham Comparator: Sham: Ureteroscope and urethral access sheath
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
The Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander.
Other: Crossover ProVee Urethral Expander System
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
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Other Names:
  • ProVee Expander
  • ProVee

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety: Number of Participants With Need for Urinary Catheterization (Time Frame: >7 Days Post Procedure)
Time Frame: 7 days post treatment through to 12 months
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)
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)
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
Safety: Adverse Events (Time Frame: Procedure to 12 Months)
Time Frame: Procedure - 12 months
This includes the rate of device or procedure related serious adverse events through 12-months.
Procedure - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ProVerum Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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