Overactive bladder (OAB) in known to greatly affect the quality of life of those who suffer from it. Although several treatment options are available, there are significant drawbacks to each. We evaluated the tolerability, usability, and satisfaction of a novel wearable neuromodulation system on patients diagnosed with OAB.

A prospective, open label study was conducted to assess the tolerability, usability, and satisfaction of a surgery-free, drug-free, wearable neuromodulation system for OAB (Avation Medical, Inc.*). After signing the informed consent, subjects were required to demonstrate severity of their OAB symptoms using a 3-day diary and show that EMG signals could be recorded with the system. A patented custom-fitted garment embedded with electrodes was used to both stimulate the tibial nerve and record EMG signals from the sole of the foot to objectively confirm nerve activation. Using an app, the clinician set up the therapy parameters which allowed for patient to control the system by an app. Enrolled subjects were instructed to use the system in their homes for 30 minutes for 3 days a week for 12 weeks. Subjects completed questionnaires that assessed their tolerability, usability, and satisfaction of the system as well as its effect on their OAB symptoms. The subject’s overall compliance of the system was also assessed.

*Investigational use only

A total of 21 subjects (1 male, 20 female) were enrolled into the study and 18 subjects completed 12 weeks of therapy. Of the 3 subjects that dropped out, one could not adhere to the visit schedule, one had foot pain, and one had device issues. Their mean age was 62 years (range 50-78). The mean duration of symptoms was 8.5 years (range 1-42 years). The most common words used to describe the stimulation were smooth, tingling and comfortable. Subjects most often administered their therapy while they were sitting (n=15) while watching TV (n=10). All subjects were found to be compliant with the therapy and treatment schedule. Of the 18 subjects who completed their 12 weeks of therapy, the majority, 94%, indicated that the system was easy to use (Figure 1). Quality of life improved from an average of 40% to 60% and symptom severity decreased from an average of 60% to 40% as measured using the OAB-q (HRQL). Most subjects, 68%, expressed overall satisfaction with the system with 72% of the subjects reporting they were to use this system in the future (Figure 2). No serious adverse events were reported.

A non-surgical, wearable neuromodulation system for the alleviation of OAB symptoms was found to be well-tolerated. Subjects were found to be satisfied with the system and compliant with the treatment protocol. A majority of subjects indicated they would use this therapy.

The Avation wearable neuromodulation system for OAB was found to be tolerable and easy to use by subjects in this trial. Additional research is required to ascertain the therapeutic effects, outcomes and long-term compliance.