Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

The purpose of this feasibility clinical investigation 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:

• Normal healthy women ≥ 21 years old
• Using contraception if of reproductive age

Exclusion Criteria:

• Pregnant, recently pregnant or actively trying to conceive
• Prior hysterectomy
• Current or recent urinary tract or vaginal infection