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.
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
- Conditions the study is for
- BPH With Symptomatic Lower Urinary Tract Symptoms
- What is being tested?
- ProVee Urethral Expander System and Urethral Access Sheath
- Type of treatment
- Medical device, Surgery or procedure
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: ProVee Urethral Expander System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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.
- First posted11 Jan 2022
- Study start9 Jun 2022
- Primary completion15 Mar 2024
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPH With Symptomatic Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ProVerum Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ProVee Urethral Expander System Clinical Study
- ClinicalTrials.gov ID
- NCT05186740
- Acronym / sponsor ID
- ProVIDE / CIP-002
- Keywords
- BPH / LUTS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 221 participants (actual)
- Lead sponsor
- ProVerum MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 1 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, multi-center, randomized, double-blind, sham-controlled safety and effectiveness study
| Arm | Type | Receives |
|---|---|---|
| Device: The ProVee Urethral Expander System | Active comparator | Device: ProVee Urethral Expander SystemThe 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. |
| Sham: Ureteroscope and urethral access sheath | Sham comparator | Procedure: Urethral Access SheathAn ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure. |
| Crossover ProVee Urethral Expander System | Other | Device: ProVee Urethral Expander SystemAll 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (44 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProVee Urethral Expander SystemAlso: ProVee Expander, ProVeeProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH. | Device | Crossover ProVee Urethral Expander System, Device: The ProVee Urethral Expander System |
| Urethral Access SheathThe Urethral Access Sheath is introduced into the prostatic urethra to simulate the placement of the ProVee Expander. | Procedure or surgery | Sham: Ureteroscope and urethral access sheath |
Primary outcome
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41396103Kaplan 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.
- ProVerum WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
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.