StimGuard said today it enrolled the 1st patient in a clinical trial of its StimGuard miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome.
The Fort Lauderdale, Fla.-based company’s system is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve and treat the symptoms of overactive bladder.
“If successfully trialed, the StimGuard technology would allow neuromodulation to be offered to patients in an office setting, which has never been the case before for a permanent, long-term treatment of urgency urinary incontinence associated with OAB. Should the study results show effectiveness, StimGuard will have the ability to treat an underserved OAB patient population with a solution that is simple and not intimidating. We look forward to positive results from the study on the path to bring this technology to the urology market,” co-founder & managing director Laura Perryman said in prepared remarks.
The randomized, controlled study of the device, dubbed “Protect”, is slated to launch in winter and aims to enroll 242 patients to examine the use of the device for treating OAB. The trial will examine the effectiveness of pulsed electrical energy delivered to the tibial nerve to regulate bladder function, the company said.
“Developing a minimally invasive implantable neuromodulation system at the tibial nerve has the potential to improve the symptoms of patients suffering from urinary urgency incontinence associated with overactive bladder without an expensive surgery. StimGuard’s technology has the potential to be that innovation,” study principal investigator Dr. Larry Sirls of the Oakland University William Beaumont School of Medicine said in a press release.
The company won FDA approval for an Investigational Device Exemption trial of the device in October.
In May, the company won its 1st IDE clearance from the FDA to run a clinical trial of the device for patients suffering from overactive bladder syndrome, saying they expected the trial to begin earlier this year.
The same wireless technology used by StimGuard is already used by sister firm Stimwave Technologies to treat chronic back and leg pain. Last December Stimwave launched a clinical trial of its miniature, wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.