FemPulse Therapy First-in-Human Experience

Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB

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 in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Inclusion Criteria:

• Females ≥21 yrs with Overactive Bladder

Exclusion Criteria:

• Is or was recently pregnant
• Has a metal pelvic implant or any electrically active implanted medical device
• Has a urinary tract or vaginal infection
• Had a previous hysterectomy, pelvic radiation or pelvic cancer
• Has significant pelvic organ prolapse
• Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
• Has a significant heart condition or a history of vasovagal reaction or low blood pressure