A simple wearable vaginal ring (FemPulse System) provides a novel non-invasive, convenient, and discreet form of neuromodulatory treatment for women with OAB. We present two studies of the FemPulse System, with objectives to evaluate ease-of-use (for both patient and provider) while assessing for meaningful efficacy and QoL.

Two prospective studies of the FemPulse System were completed at 2 US sites involving subjects with symptomatic OAB. This non-implanted vaginal neuromodulation therapy includes: (1) Ring worn in the vagina, (2) Remote Control for self-adjustment of stim levels, (3) Recharging station, and (4) Clinician Programmer for setting stim parameters.  In Study 1, the Ease-of-Use Study, subjects underwent an in-clinic fitting, followed by device activation and continued use for 2 days. In Study 2, the 4-week Usability Study, subjects completed a baseline 7-day electronic bladder diary and QoL assessments, followed by 1 week of wear without stim, then 2 weeks of wear with stim. Bladder Diary and QoL outcomes were collected during the second week of stim.  Validated questionnaires included: OAB-q Short Form (OAB-q SF), International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB), and Incontinence Quality of Life Questionnaire (IQOL).

Study 1 (Ease-of-Use Study): Initial enrollment was 11, with 10 (91%) having a successful device fitting (mean age=59.5 years, range: 45–82 years).  Of these, 6 (60%) reported the Ring was easy or very easy-to-use within just the 2 days of the trial.  Also, the clinicians reported the device was easy-to-use and program. 
Study 2 (Usability Study): All 5 subjects (100%) had successful device fittings, completed the study (mean age=52.2 yrs, range: 25–74 yrs), and reported the Ring was initially easy-to-use or became easier-to-use with experience. Diaries noted a marked reduction in mean voids/day of 5.23 (baseline 13.43 to 8.20 voids/day). All subjects noted meaningful clinical improvements, with a mean reduction of OAB q SF Symptom Bother Score from 68 to 28 (4 times the MCID). Four (80%) patients had marked reductions in uncomfortable urgency (on 6-pt scale). QoL scores noted positive impacts following stim (IQoL:  Baseline 47.27 to 67.95). No adverse events were reported.

These data collectively note the FemPulse System is easy to use (place and remove), comfortable to wear, and easy to manage for both the patient and clinician.  Furthermore, it provides meaningful clinical improvements in OAB symptoms, most notably for bothersome urinary frequency with a mean reduction of 5.23 voids/day; as well as a marked reduction in uncomfortable urgency, which is undoubtedly the hallmark of OAB. Accordingly, concomitant improvements in OAB Bother Score and QoL were seen.

Two studies of the non-invasive, wireless, wearable vaginal ring, the FemPulse System, confirm wearability, ease-of-use for both subjects and clinicians, and meaningful improvements in OAB symptoms and QoL. This usability and efficacy data confirm prior studies of a prototype device (with external wires), providing further evidence for FemPulse as a next-generation non-invasive form of neuromodulation therapy for women with OAB.  A prospective multi-center randomized control trial against a standard OAB medication (EVANESCE II) is currently underway as a pivotal IDE study for FDA De Novo clearance.