FemPulse Therapy for Overactive Bladder in Women

Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder

The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Inclusion Criteria:

• Females 21 years or older with a diagnosis of Overactive Bladder
• If of reproductive age, must use a reliable form of contraception

Exclusion Criteria:

• Pregnant, was recently pregnant or is trying to conceive
• Has a metal pelvic implant or any electrically active implanted medical device
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months
• Has a significant heart condition