ProVee Urethral Expander System for Benign Prostatic Hyperplasia

(ProVIDE Trial)

Not currently recruiting at 16 trial locations

Overseen By Samuel Lawindy

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: ProVerum Medical

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

Disqualifiers: Prostate cancer, UTI, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: Procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment option for men with benign prostatic hyperplasia (BPH), a condition that causes urinary problems due to an enlarged prostate. The study tests the ProVee Urethral Expander System, a medical device designed to relieve urinary obstruction. Participants will either receive the actual device or undergo a sham procedure, with the option to switch to the device later. Men with urinary symptoms related to BPH who have not found success with medication may be suitable for this trial. As an unphased trial, it offers participants the chance to access innovative treatment options that could enhance their quality of life.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications before joining the trial. The trial requires stopping some medications like alpha-blockers, 5-alpha-reductase inhibitors, and certain others within specific timeframes before the study begins.

What prior data suggests that the ProVee Urethral Expander System is safe for treating benign prostatic hyperplasia?

Research has shown that the ProVee Urethral Expander System is generally safe for treating urinary blockage caused by an enlarged prostate, known as benign prostatic hyperplasia (BPH). One study found that the ProVee System met all safety standards and led to significant improvements without major safety concerns.

Another review examined 2,567 reports on various BPH devices, including the ProVee System, and found that over 99% of patients did not experience issues from device malfunctions. This suggests that most people tolerate the treatment well.

Overall, these findings indicate that the ProVee Urethral Expander System is safe for use with a low risk of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ProVee Urethral Expander System because it offers a new approach for treating benign prostatic hyperplasia (BPH), a condition that traditionally relies on medications like alpha-blockers and 5-alpha-reductase inhibitors, or surgical procedures like TURP (transurethral resection of the prostate). Unlike these options, the ProVee system uses a nitinol Expander implant to physically widen the urethra, potentially relieving symptoms without the need for invasive surgery. This system is delivered under direct vision using a specially designed delivery system, which may reduce the risks and recovery time associated with more invasive procedures. By focusing on a mechanical solution to open the urethra, the ProVee system could offer faster symptom relief and fewer side effects compared to medication.

What evidence suggests that the ProVee Urethral Expander System is effective for benign prostatic hyperplasia?

Research has shown that the ProVee Urethral Expander System holds promise for treating benign prostatic hyperplasia (BPH), a condition that obstructs urine flow. In this trial, participants may receive the ProVee system, which studies have shown improves the International Prostate Symptom Score (IPSS) by an average of 9.5 points. In contrast, those in the sham arm, receiving a placebo treatment, improved by 5.6 points. Another review found that after one year, patients experienced a 45% reduction in symptoms and a 67% increase in urine flow. Additionally, over 99% of patients reported no issues from device malfunctions. These findings suggest that the ProVee system can effectively reduce symptoms and improve urine flow in BPH patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Men with symptoms of urinary obstruction due to benign prostatic hyperplasia (BPH), who haven't had prostate/bladder cancer, urinary stones, blood in urine recently, or prior prostate procedures. Candidates should not be on medications like finasteride or dutasteride for urination issues and have a prostate size between 30 cc and 80 cc.

Inclusion Criteria

I have been diagnosed with an enlarged prostate.

I have not had any procedures done on my prostate.

I have tried and cannot tolerate medication for urinary symptoms, or I choose not to take them.

Exclusion Criteria

I have taken medication to help with urination, like Proscar, Avodart, or Jalyn.

The length of a specific part of your prostate called the prostatic urethra is longer than 3.75cm, as measured by a special ultrasound exam called TRUS.

I have had procedures done on my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ProVee Urethral Expander System or undergo a sham procedure

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits (in-person)

Crossover

Subjects in the Sham Arm are given the opportunity to crossover to the ProVee Urethral Expander System after the 3-month follow-up

Post 3-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• ProVee Urethral Expander System

Trial Overview The trial is testing the ProVee Urethral Expander System's safety and effectiveness compared to a standard urethral access sheath in men with BPH-related urinary problems. The goal is to see if this new device can improve symptoms by expanding the urethra.

How Is the Trial Designed?

Group I: Crossover ProVee Urethral Expander System Experimental Treatment 1 Intervention

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.

Group II: Device: The ProVee Urethral Expander System Active Control 1 Intervention

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.

Group III: Sham: Ureteroscope and urethral access sheath Placebo Group 1 Intervention

An ureteroscope housed within the inner lumen of an urethral access sheath will be used under direct vision for the Sham procedure.

Who Is Running the Clinical Trial?

ProVerum Medical

Lead Sponsor

Trials

3

Recruited

280+

Published Research Related to This Trial

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]

The Optilume BPH Catheter System is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that combines balloon dilation with localized delivery of paclitaxel, which helps maintain long-term effectiveness.

This system can be used in an office setting without the need for general anesthesia, and early data suggest it leads to positive functional and sexual outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: Optilume BPH catheter system. Elterman, DS., Gao, B., Zorn, KC., et al.[2023]

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]

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 Optilume BPH Catheter System significantly improved lower urinary tract symptoms (LUTS) in 80 subjects over 2 years, with IPSS scores dropping from 22.3 to 8.2, indicating effective symptom relief.

Functional improvements were also notable, with peak urinary flow rate (Qmax) increasing from 10.9 mL/s to 17.2 mL/s, and post-void residual urine volume (PVR) decreasing from 63.1 mL to 45.0 mL, while treatment-related adverse events were mostly minor and none occurred after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. Pichardo, M., Rijo, E., Espino, G., et al.[2023]

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]

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

Investigational ProVee System impresses in phase 3 trial ... Patients in the ProVee arm had a mean IPSS improvement of –9.5 vs –5.6 in the sham arm (P = .001). In addition, “The primary effectiveness end ...

3. 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 ...

4. withpower.com withpower.com/trial/phase-49160

ProVee Urethral Expander System for Benign Prostatic ... A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a ...

5. trialx.com trialx.com/clinical-trials/listings/274998/provee-urethral-expander-system-ide-study-provide/

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

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05186740/provee-urethral-expander-system-ide-study-provide

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