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BPH With Symptomatic Lower Urinary Tract SymptomsNCT06236802

ProVIDE II Bridging Study

A study testing ProVee device in people with BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical at 8 sites in 2 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

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. 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 device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
8 sitesin 2 countries
Study dates
6 Mar 2024to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 ≥ 3.75 cm 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 > 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
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., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patient unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin 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 haemorrhoidectomy) 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

8 sites in 2 countries.

8 sites in 2 countries

United States7 sites

  • Midtown Urology Assoc. PA

    Austin, Texas, 78705

  • Urology Austin

    Austin, Texas, 78745

  • Houston Methodist Research Institute

    Houston, Texas, 770030

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

  • Sheldon Freeman MD LTD

    Las Vegas, Nevada, 89144

  • Florida Urology Partners, LLP

    Tampa, Florida, 33606

  • Avant Concierge Urology

    Winter Garden, Florida, 34787

Other trials in United States

Ireland1 site

  • St James Hospital

    Dublin

Other trials in Ireland

About this study

Official title: ProVIDE II Bridging Study for the ProVee System for BPH

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.

Read the detailed description

This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).

Being tested
ProVee device
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 deviceDevice

    Also called ProVee Expander, ProVee

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

Study groups in NCT06236802
Study groupRoleWhat they receive
ProVee treatmentExperimentalProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Receives: Device: ProVee device

What is being measured

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

  1. Serious Adverse Events

    Rate of device or procedure related serious adverse events through 3-months.

    Measured: (time frame: procedure to 3 months)

  2. Need for urinary catheterization

    The rate of extended post-operative urinary catheterization (> 7 days from treatment) for inability to void among patients treated with the ProVee System for BPH.

    Measured: (time frame: >7 days post procedure to 3-months)

  3. Technical Success

    The percentage of subjects where the expander is deployed in the location intended by the user. This endpoint will be met if the Observed Technical Success is >95%.

    Measured: Procedure

Timeline

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

  1. First posted1 Feb 2024
  2. Study start6 Mar 2024
  3. Primary completion6 Sep 2024
  4. Study completion1 Jun 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236802
Sponsor's protocol ID
CIP 003
Status last verified
Jul 2026
First submitted
24 Jan 2024
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plan to make individual participant data (IPD) available to other researchers

Questions about this trial

What is this clinical trial studying?

A study testing ProVee device in people with BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical at 8 sites in 2 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 9 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 8 sites in United States, 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Serious Adverse Events (time frame: (time frame: procedure to 3 months)). The study lists 3 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 NCT06236802.

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 9 Jul 2026.

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