Evaluation of the FemPulse Non-Implanted Electrical Stimulation Device Compared to Medication for Treating Overactive Bladder in Women 21 Years and Older

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the FemPulse System, a non-implanted electrical stimulation device, for treating Overactive Bladder OAB in women aged 21 years and older. The study compares this device with medication treatment to better understand options for managing OAB symptoms such as urinary urgency and frequency. Participants are randomly assigned to one of two groups one group receives the FemPulse non-implanted vaginal electrical stimulation device, while the other group receives medication for OAB. The study is designed as a parallel interventional trial without masking. Treatments and procedures will be followed and assessed over a period extending to the studys completion in late 2027. During the study, participants will undergo regular assessments including monitoring the mean change in the number of voids per day over six months. They will be expected to comply with study procedures such as consistent medication use, fluid intake, and diary completion. Researchers will monitor safety and effectiveness outcomes throughout the trial period, with the primary completion date in May 2027 and full study completion at the end of 2027.

Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)