SUFU 2021: The Evaluation of a Novel Non-Surgical, Wearable, Neuromodulation System for Use in the Home on Patients With Overactive Bladder
This therapy is a custom-fitted garment embedded with electrodes, used transcutaneously to stimulate the tibial nerve and record electromyography (EMG) signals from the sole of the foot. Subjects recorded overactive bladder (OAB) symptoms on a 3-day diary. EMG signals had to be successfully recorded with the system. The clinician set up the therapy parameters allowing for the patient to do the therapy at home. The therapy was for a 12-week period. Stimulation was 3 times per week for 30 minutes. Subjects were contacted weekly by phone and with in-person evaluations at weeks 1, 4, 8, and 12. A preliminary evaluation of 10 enrolled subjects (mean age 62 years, range 50-78) who completed their 12 weeks were included in this analysis (1 male; 9 females). The mean duration of symptoms was 8.5 years (range 1-42 years). All subjects were satisfied and compliant with the therapy and treatment schedule. Stimulation was found to be “smooth” and “tingling”. The optimal location for stimulation using the evoked EMG signal was from the bottom of the foot. No unanticipated serious adverse events were reported. Only one subject reported pain in the limb being stimulated which subsided once stimulation was stopped. Seventy percent reported they were likely or very likely to use this system in the future. The small study of a non-surgical, wearable neuromodulation system for OAB, for use in the home.
Presented by: Denise Elser, Nel Gerig, Samir Arora, Kavi Rajendran, Breanne Mangione, Jessica Spear, Samuel Young, Tracy Cameron
Women’s Health Institute of Illinois, The Pelvic Solutions Center, Aventiv Research, Avation Medical
Written by: Diane K. Newman, DNP, CRNP, FAAN, BCB-PMD, Nurse Practioner and Co-Director, Penn Center for Continence and Pelvic Health Adjunct Professor of Urology in Surgery during the 2021 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting.