ProVee Device for Enlarged Prostate

Not currently recruiting at 7 trial locations

Overseen By Michael Lyon

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: ProVerum Medical

Must not be taking: Antidepressants, Anticoagulants, Antihistamines, others

Disqualifiers: Prostate cancer, Diabetes, UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ProVee device to evaluate its effectiveness in helping men with urinary problems caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH). The ProVee device is inserted into the prostate area to relieve blockage and improve urine flow. Men over 45 years old who have tried medication for BPH symptoms without success or opted not to take it may be suitable candidates for this trial.

As an unphased trial, this study provides an opportunity to explore a new treatment option for BPH symptoms.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. For example, you must stop using 5-alpha-reductase inhibitors 6 months before, alpha-blockers 2 weeks before, and some other medications like anticoagulants a few days before the procedure. Check with the trial team for specific guidance on your medications.

What prior data suggests that the ProVee device is safe for treating enlarged prostate?

Research has shown that the ProVee device is generally safe for individuals with an enlarged prostate. In a study involving 10 patients over 24 months, the ProVee device effectively reduced symptoms of urinary blockage related to benign prostatic hyperplasia (BPH), a non-cancerous prostate enlargement. A review of similar prostate stents found that these devices can be safe and improve quality of life. The ProVee System is a treatment that can be safely performed in a doctor's office, offering convenience and reliability. Overall, early findings suggest that the ProVee device is well-tolerated, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ProVee device is unique because it offers a non-surgical approach to treating an enlarged prostate, specifically targeting the prostatic urethra to relieve obstruction caused by benign prostatic hyperplasia (BPH). Unlike traditional treatments like medications or invasive surgeries such as transurethral resection of the prostate (TURP), the ProVee device is a minimally invasive expander that is placed directly in the urethra. Researchers are excited about this treatment because it has the potential to provide relief with fewer side effects and a quicker recovery time, making it a promising alternative for those seeking less invasive options.

What evidence suggests that the ProVee device is effective for enlarged prostate?

Research has shown that the ProVee device, which participants in this trial will receive, effectively treats urinary blockage caused by benign prostatic hyperplasia (BPH). In one study, the ProVee system met all safety and effectiveness goals, providing significant symptom relief. Another study found that after using the ProVee device, patients reported a 45% reduction in symptom scores and a 67% improvement in urine flow. Additionally, data over 24 months show that the device can safely reduce urinary symptoms over time. The ProVee device works by gently widening the blocked urethra, improving urine flow without the need for surgery. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for men over 45 with bothersome urinary symptoms due to an enlarged prostate, who have not had success with or cannot take medications for these symptoms. They should have a certain level of symptom severity and prostate size.

Inclusion Criteria

Prostatic urethral L2 lengths ≥ 3.75 cm by TRUS

I am a man older than 45.

IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment

Exclusion Criteria

Future fertility concerns

Requiring self-catheterization to void

I have used hormone therapy within the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

Procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ProVee device

Trial Overview The ProVIDE II study is testing the Generation II delivery system's ability to place the ProVee expander in patients suffering from urinary blockage caused by an enlarged prostate (BPH).

How Is the Trial Designed?

Group I: ProVee treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

ProVerum Medical

Lead Sponsor

Trials

3

Recruited

280+

Published Research Related to This Trial

The Urolume self-expanding flexible endourethral stent was found to be effective in improving symptoms and urinary flow rates in patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH), with significant improvements noted over a 5-year follow-up period.

Despite a high failure rate attributed to selection and deployment challenges, the Urolume stent was confirmed to be a safe device, with most patients experiencing sustained symptom relief and good quality of life after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. Anjum, MI., Chari, R., Shetty, A., et al.[2019]

A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a high level of safety across the modalities studied.

The use of morcellators during HoLEP was associated with the highest rate of serious complications, suggesting that urologists should be cautious and choose devices they are most familiar with to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. Patel, NH., Uppaluri, N., Iorga, M., et al.[2021]

In a study of 3,047 men with lower urinary tract symptoms due to benign prostatic hyperplasia, the first year of treatment with doxazosin, finasteride, or combination therapy showed significantly higher rates of adverse experiences, particularly sexual function issues and dizziness.

Men on combination therapy reported the highest incidence of adverse effects in the first year, with rates 3.4 to 10.6 times higher than after the first year, highlighting the importance of monitoring and discussing these potential side effects with patients during initial treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time Course of Incident Adverse Experiences Associated with Doxazosin, Finasteride and Combination Therapy in Men with Benign Prostatic Hyperplasia: The MTOPS Trial. Kaplan, SA., Lee, JY., Meehan, AG., et al.[2022]

The Urocross Expander System was successfully implanted in 8 male canines, leading to a significant increase in urethral width (from 6.9 mm to 10.2 mm) without causing obstruction or retention, indicating its potential efficacy for treating urinary tract symptoms.

The device showed a favorable safety profile, with minimal adverse events and no significant tissue growth, encrustation, or stone formation observed post-retrieval, suggesting it may be a safe option for managing benign prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of a Novel Implant Intended to Expand and Reshape the Prostatic Urethra for the Treatment of Benign Prostatic Hyperplasia: A Pre-Clinical Feasibility Study in the Canine Model. Chughtai, B., Punyala, A., Lata, SS., et al.[2022]

A total of 433 adverse events (AEs) were reported from laser use in urology, with the majority (46%) linked to equipment failures like generator malfunctions or fiber tip breakage.

Significant patient harm was noted, including 36 AEs resulting in injury and 7 fatalities, primarily from ureteral perforation and air emboli associated with specific lasers, highlighting the need for caution and protective measures during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events resulting from lasers used in urology. Althunayan, AM., Elkoushy, MA., Elhilali, MM., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05186740

ProVee Urethral Expander System IDE Study (ProVIDE) A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11143863/

Prostatic stents: a narrative review of current evidence - PMC After 1 year, the IPSS decreased by 45%, while the maximum urinary flow rate (Qmax) increased by 67%. Early complications included prostate ...

3. urologytimes.com urologytimes.com/view/investigational-provee-system-impresses-in-phase-3-trial-in-bph

Investigational ProVee System impresses in phase 3 trial ... The ProVee Urethral Expander System met all safety and effectiveness endpoints in a phase 3 study for BPH, showing significant symptom ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003346.04

PD41-04 FIRST IN MAN CLINICAL DATA THROUGH 24 ... The 24-month data from this FIM study of 10 subjects demonstrates the ProVee can safely alleviate LUTS in men with benign prostatic hyperplasia.

5. eithealth.eu eithealth.eu/wp-content/uploads/2022/12/ProVerums-journey-to-Series-A-success.pdf

Community Stories The ProVerum team came up with ProVee, a 'stent-like' expander designed to gently 'open-up' the obstructed urethra without heating, piercing, cutting, or ...

6. urologytimes.com urologytimes.com/view/patient-treatment-begins-in-trial-of-novel-device-for-bph

Patient treatment begins in trial of novel device for BPH "The ProVee System has the potential to be an effective treatment for BPH that can be safely and reliably performed in the office setting," ...

7. proverummedical.com proverummedical.com/

Proverum Medical | ProVee System The ProVee stent uses 3-D geometry which mirrors and engages with the anatomy of the prostate. The system alleviates Lower Urinary Tract Symptoms (LUTS)