ProVee Device for Enlarged Prostate

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

40 Participants Needed

Trial Summary

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.

Is the ProVee device generally safe for treating an enlarged prostate?

The ProVee device, like other treatments for an enlarged prostate, has been associated with minimal patient harm, with over 99% of patients experiencing no complications after device malfunction. However, care should be taken with certain devices, as some complications may arise from user misuse. ^{1 2 3 4 5}

How is the ProVee device treatment for enlarged prostate different from other treatments?

The ProVee device is unique because it is a minimally invasive treatment that uses an implant to expand and reshape the prostatic urethra, which helps relieve symptoms of an enlarged prostate. Unlike traditional surgeries, it aims to provide relief without extensive tissue removal or cutting. ^{3 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The North American experience with the UroLume endoprosthesis as a treatment for benign prostatic hyperplasia: long-term results. The North American UroLume Study Group. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Endoscopic rollerball electrovaporization of the prostate--the sandwich technique: evaluation of the initial efficacy and morbidity in the treatment of benign prostatic obstruction. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Adverse events resulting from lasers used in urology. [2019]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A simple artificial implantable sphincter. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Prostatic Urethral Lift: Does Size Matter? [2019]

9. England pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. [2019]