The first procedure with the novel ProVee System has been successfully completed in the pivotal ProVIDE trial, according to ProVerum Limited, the company developing the nitinol expander device for patients with benign prostatic hyperplasia (BPH).1
According to ProVerum, “ProVee is a self-expanding implant that, once positioned, gently re-shapes and opens the narrowed urethra to improve urinary flow.” The initial procedure was done at Avant Concierge Urology, Winter Garden, Florida, by the principal investigator at the site, Sijo Parekattil, MD.
"The ProVee procedure is straightforward and comfortably performed in a doctor's office," Parekattil stated in a news release. "I see many patients whose quality of life are adversely impacted by the symptoms associated with an enlarged prostate and the ProVee System represents an exciting new alternative for BPH treatment."
The multicenter, double-blinded, prospective ProVIDE trial is evaluating the efficacy and safety of the ProVee System in patients with BPH-related lower urinary tract symptoms. The study is being conducted at 18 clinical sites in the United States, as well as 4 international locations. The target enrollment of the trial is 225 patients.
Patients enrolled in the trial will be randomized to receive treatment with the ProVee System or undergo a sham procedure. Unblinding of patients will occur after 3 months, at which point individuals randomized to the sham procedure who meet prespecified study criteria will be eligible for ProVee treatment. The International Prostate Symptom Score (IPSS) will be used to assess primary efficacy, which will be determined by IPSS changes from baseline to 3 months and 12 months.
"The ProVee System has the potential to be an effective treatment for BPH that can be safely and reliably performed in the office setting" Steve Kaplan, MD, global lead investigator for the ProVIDE study and professor of Urology at the Icahn School of Medicine at Mount Sinai in New York, stated in the news release. "This international, multi-center clinical study will thoroughly evaluate the safety, efficacy and long-term durability of the ProVee device and I look forward to presenting the data from this large controlled clinical trial."
1. ProVerum: First Enrolment in the ProVIDE Clinical Study for BPH Treatment. Published online June 13, 2022. Accessed June 22, 2022. https://prn.to/3HSEKXH