Medical device company StimGuard has started enrolling for PROTECT clinical trial of its miniature implantable device to treat urgent urinary incontinence resulting from refractory overactive bladder (OAB) syndrome.
Claimed being the smallest wireless system, the StimGuard device operates based on wireless technology and is implanted at the tibial nerve through a needle-sized introducer device to activate the afferent micturition (neural urinary) pathways.
Oakland University William Beaumont School of Medicine professor and William Beaumont Hospital female pelvic medicine and reconstructive surgery director and study principal investigator Dr Larry Sirls 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.”
The randomised, controlled PROTECT study will be conducted to compare efficacy of the new StimGuard long-term chronic implantable device therapy with a recurring treatment therapy, which requires frequent visits to the clinician’s office.
Enrolling 242 patients, the clinical trial will implant a small neurostimulator at the tibial nerve under ultrasound guidance and use a discreetly worn external transmitter to provide energy and therapy to the implanted device at night.
StimGuard co-founder and managing director Laura Tyler Perryman said: “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.”
The trial will evaluate efficacy of delivering pulsed electrical energy to surrounding tibial nerves that travel to the sacral nerves to control bladder function.