Study of ProVee System for BPH hits enrollment goal

The target enrollment has been met in the ProVIDE trial (NCT05186740), which is evaluating the safety and efficacy of the ProVee System, a stent-like urethral expander for the treatment of patients with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), announced ProVerum, the developer of the therapy, in a news release.¹

In addition to the ProVIDE trial, ProVerum also announced the commencement of the ProVIDE II Bridging study, which will evaluate the performance of a delivery system for deploying the ProVee expander.

"The ProVee System has the potential to be a first-line interventional therapy for BPH that can be safely and reliably performed in the office setting. This large international, multi-center clinical study, which is now fully enrolled, thoroughly evaluates the safety, efficacy, and long-term durability of the ProVee device, and I look forward to presenting the data," said global lead investigator Steven A. Kaplan, MD, in the news release.¹ Kaplan is a professor of urology at the Icahn School of Medicine at Mount Sinai in New York.

Overall, the prospective, double-blind controlled ProVIDE trial is designed to assess the safety, performance, and effectiveness of the ProVee system in patients with BPH-related LUTS. In total, the study has enrolled 221 male patients across 15 clinical sites in the US and 2 clinical sites internationally.

Patients enrolled in the study will be randomly assigned 2:1 to receive treatment with ProVee or to a sham comparator arm. At 3 months, patients in the sham arm will be unblinded and given the opportunity to cross over to the treatment arm. The primary outcome measures for the trial include the rate of device- or procedure-related serious adverse events (AEs), the rate of extended post-operative urinary catheterization, a reduction in BPH symptoms in the treatment arm compared with the sham arm, and the mean percent change in International Prostate Symptom Score (IPSS) from baseline to 3 and 12 months.²

In addition to the ProVIDE trial, ProVerum also announced the commencement of the ProVIDE II Bridging study (NCT06236802), which will evaluate the performance of a second-generation delivery system for deploying the ProVee expander.

The flexible, steerable delivery system is the same diameter as a diagnostic cystoscope and is best suited for use in an office or out-patient setting. The first procedure with the system was performed by the trial’s principal investigator, Brian Mazzarella, MD.

"The new delivery system is straightforward to use and works similarly to a flexible cystoscope that all urologists use routinely in the office setting. I see many dissatisfied patients whose BPH symptoms are not resolved by medication, yet they are unwilling to undergo more invasive surgical procedures. The atraumatic nature of ProVee may make it an option that patients would actually choose to have and thus improve their lives and avoid further bladder damage,” said Mazzarella, a urologist at Urology Austin in Texas, in the news release.¹

Overall, the prospective, open-label, non-randomized bridging study is enrolling up to 50 male patients with BPH-related LUTS across 7 clinical trial sites in the US and 1 international site. Primary outcome measures for the study include the rate of serious AEs, the rate of extended post-operative urinary catheterization, and the percentage of patients who achieve technical success, defined as deployment of the expander in the intended location.³

Inclusion criteria for both ProVIDE and the Bridging trial includes an IPSS of 13 or higher and an IPSS Voiding/Storage subscore of greater than 1 at baseline, a prostate volume between 30 to 80 cc, prostatic urethral L2 lengths of 3.75 cm or greater per transrectal ultrasound, and either failed, intolerant, or patient choice not to receive a medication regimen for the management of BPH-related LUTS.

Primary completion of both studies is expected in June 2024.

References

1. ProVerum announces completion of enrollment for the ProVIDE clinical study for BPH and first-use of its new flexible, steerable delivery system. News release. ProVerum. Published online and accessed March 20, 2024. https://www.prnewswire.com/news-releases/proverum-announces-completion-of-enrollment-for-the-provide-clinical-study-for-bph-and-first-use-of-its-new-flexible-steerable-delivery-system-302093617.html

2. ProVee urethral expander system IDE study (ProVIDE) (ProVIDE). ClinicalTrials.gov. Last updated January 25, 2024. Accessed March 20, 2024. https://clinicaltrials.gov/study/NCT05186740

3. ProVIDE II Bridging Study. ClinicalTrials.gov. Last updated February 1, 2024. Accessed March 20, 2024. https://clinicaltrials.gov/study/NCT06236802