FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--StimGuard, a privately-held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first miniature implantable device for the treatment of urgency urinary incontinence resulting from refractory overactive bladder (OAB) syndrome. The StimGuard device utilizes wireless technology and is placed through an introducer device the size of a needle at the tibial nerve to activate the afferent micturition (neural urinary) pathways. The clinical trial of this novel approach will launch this winter.
"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,” said Dr. Larry Sirls, Oakland University William Beaumont School of Medicine Professor and Director of Female Pelvic Medicine and Reconstructive Surgery at William Beaumont Hospital in Royal Oak, Michigan, a recognized authority on incontinence. “StimGuard’s technology has the potential to be that innovation,” he said. Dr. Sirls serves as the Principal Investigator at Beaumont Hospital for the StimGuard tibial study, the site that enrolled the first patient.
More than 37 million Americans – one out of every six adults – live with some level of OAB. OAB treatment varies depending on the severity of the symptoms, with the modality estimated to cost the U.S. healthcare system more than $60 billion per year.
The “PROTECT” Study will include approximately 242 patients. This is a randomized, controlled study that compares the efficacy of the new StimGuard long-term chronic implantable device therapy to a recurring treatment therapy, which requires over a dozen weekly visits to the office. This clinical trial will focus on implanting a small neurostimulator at the tibial nerve under ultrasound guidance and utilizing a discreetly worn external transmitter to provide energy and therapy to the implanted device at night. The clinical trial will assess the effectiveness of delivering pulsed electrical energy to surrounding tibial nerves that travel to the sacral nerves to regulate bladder function.
“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,” said Laura Tyler Perryman, managing director and co-founder of StimGuard. “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.”
For more information about the StimGuard clinical trials, please visit www.clinicaltrials.gov.
StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective urological solution that is easily incorporated into their daily lives. StimGuard’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of urinary management. www.stimguard.com