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BPH With Symptomatic Lower Urinary Tract SymptomsProVIDENCT05186740

ProVee Urethral Expander System IDE Study (ProVIDE)

A study testing ProVee Urethral Expander System and Urethral Access Sheath in people with BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical at 16 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 45 years and older, men onlyHealthy volunteers can take part
What is being tested?
ProVee Urethral Expander System and Urethral Access Sheath
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
221 participants
Where
16 sitesin 3 countries
Study dates
9 Jun 2022to Dec 2028
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 44Show fewer
  • 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
  • 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)
  • Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment
  • 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
  • Future fertility concerns
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants
  • Previous pelvic irradiation or radical pelvic surgery
  • Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease
  • Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology
  • Urethral pathologies that may prevent insertion of Delivery System
  • Uncontrolled diabetes mellitus including Hgb AIC >8%
  • Overactive bladder (OAB) requiring treatment by OAB medication
  • Urinary incontinence
  • Patients taking tri-cyclic antidepressants.
  • Compromised renal function (i.e., serum creatinine >1.8 mg/dl or upper tract disease)
  • 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
  • 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
  • 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)
  • History or current medical condition that would result in an unacceptable patient risk if that subject were to be included in the study
  • Any subject that is currently enrolled in another ongoing investigational study.

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

United States14 sites
  • Midtown Urology Assoc.

    Austin, Texas, 78705

  • Urology Austin

    Austin, Texas, 78745

  • Urological Research Network Corp

    Hialeah, Florida, 33016

  • Houston Methodist

    Houston, Texas, 77030

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Sheldon Freedman MD

    Las Vegas, Nevada, 89144

  • Mount Sinai

    New York, New York, 10011

  • Advanced Urology Institute

    Palm Coast, Florida, 32164

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Golden State Urology

    Sacramento, California, 95823

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Tampa Urology LLC

    Tampa, Florida, 33606

  • Urology of Virginia

    Virginia Beach, Virginia, 23462

  • Avant Concierge Urology

    Winter Garden, Florida, 34787

Other trials in United States

Canada1 site
  • University Health Network

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Ireland1 site
  • St James's Hospital

    Dublin

Other trials in Ireland

About this study

Official title: 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).

Read the 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.

Being tested
ProVee Urethral Expander System, Urethral Access Sheath
Keywords
BPH / LUTS
Medical subject headings
Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProVee Urethral Expander SystemDevice

    Also called ProVee Expander, ProVee

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

  • Urethral Access SheathProcedure or surgery

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

Study groups in NCT05186740
Study groupRoleWhat they receive
Device: The ProVee Urethral Expander SystemActive comparatorThe 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.
Receives: Device: ProVee Urethral Expander System
Sham: Ureteroscope and urethral access sheathSham comparatorAn ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.
Receives: Procedure: Urethral Access Sheath
Crossover ProVee Urethral Expander SystemOtherAll 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.
Receives: Device: ProVee Urethral Expander System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Procedure - 12 months

  2. 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.

    Measured: 7 days post treatment through to 12 months

  3. 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.

    Measured: Procedure to 3 months

  4. 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.

    Measured: Procedure to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start9 Jun 2022
  3. Primary completion15 Mar 2024
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multi-center, randomized, double-blind, sham-controlled safety and effectiveness study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05186740
Sponsor's protocol ID
CIP-002
Acronym
ProVIDE
Status last verified
Jul 2026
First submitted
23 Dec 2021
Last updated
28 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 41396103

Questions about this trial

What is this clinical trial studying?

A study testing ProVee Urethral Expander System and Urethral Access Sheath in people with BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: Adverse Events (Time Frame: Procedure to 12 Months) (time frame: Procedure - 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05186740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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