Hypothesis / aims of study
This clinical study aims to establish the efficacy of a new, use-at-home, perineal-applied, electrical stimulation device for the treatment of urgency urinary incontinence. Two candidate therapeutic waveforms are considered, with an aim of identifying a preferred configuration for future commercialization.
Study design, materials and methods
A prospective case series with targeted enrollment of 40+ participants was developed to achieve the study aims. The protocol is largely based on the clinical study conducted to support FDA-clearance for a configuration of the same device intended to treat female stress urinary incontinence. The protocol received IRB approval (WCG IRB #20203301) and all participants provided informed consent.
Candidate participants were recruited from social media advertisements and completed a screening questionnaire. Eligible candidates self-identified as having predominant urgency urinary incontinence with mild to moderate symptoms (1-5 leaks/day). Exclusion criteria included active urinary tract infection, recent pelvic surgery, and BMI > 35, among others. Prior to treatment, participants maintained an incontinence log for one week and completed the I-QoL questionnaire.
Study participants self-administered treatment with a modified configuration of the ELITONE® device (Elidah, Inc., Monroe, CT USA). The device (Figure 1) comprises a disposable cutaneous electrode with four conductive regions spaced across an hourglass-shaped profile that conforms to the female perineal anatomy. A wearable controller outputs modulated electrical current intended to stimulate pelvic floor tissues. The patient controls the output intensity up to 30mA. The device firmware was modified to output one of two repeating sequences: (1) URGE - 10 Hz stimulation for 6 seconds followed by 6 seconds of no stimulation, or (2) MIXED - 4 seconds at 50 Hz, 4 seconds at 10 Hz, and 6 seconds of no stimulation. Participants were randomly assigned to device configuration and study personnel were blinded to the extent possible.
Treatment consisted of 20-minute sessions, five times per week for six weeks. An incontinence log was maintained throughout and the I-QoL questionnaire was repeated at the end of the study. The primary outcome measure is the percentage of participants who achieved a clinically significant (≥50%) reduction in urgency incontinence episodes (i.e. leaks) [REF 1]. Secondary measures include changes in leaks by type/situation, bathroom visits, reduction in pad use, and change in I-QoL score.
Results
The study is ongoing. This abstract reports preliminary data on the first 23 participants to complete treatment and return post-study materials. Key participant demographics presented as mean and range include: Age – 50 [29-72], BMI - 25 [18-35], and years with incontinence - 10 [1-30].
19 of 23 participants (83%) are considered responders, having achieve a clinically significant (≥50%) reduction in the number of urgency leaks. The average reduction was 77% [100% to -55%] for all participants, with a 63% and 79% reduction for the URGE and MIXED device configurations, respectively. An unpaired t-test comparing the two configurations yielded a p-value of 0.36, which suggests no/limited difference between the treatments; however, the small group size and inherent data skewness suggests that the full dataset will be necessary to select a preferred device configuration. Other outcome measures achieved similar reduction/improvement as detailed in Table 1. Notably, the I-QoL scores improved by 31.5 points. No adverse health events were reported by any of the participants.
Interpretation of results
The preliminary data supports the use of perineal-applied electrical stimulation as a treatment for female urgency urinary incontinence. Clinically meaningful improvements have been observed across multiple outcome measures. This outcome is consistent with studies of vaginally-applied electrical muscle stimulation and other electrical stimulation therapies including percutaneous tibial nerve stimulation and sacral nerve stimulation neuromodulation [REF 2]. Further, improvements in leaks, pad usage, and I-QoL scores are similar to those reported for the commercially available ELTITONE device in its intended use as a treatment for female stress urinary incontinence [REF 3].
The lack of a statistically measurable difference between the device configurations is not unexpected, particularly with just over half of the target enrollment reporting results. Current practice supports use of a 10 Hz stimulation frequency in treating urgency, and a 50 Hz frequency for stress incontinence. However, given that most incontinent women have components of both stress and urgency, and that the literature has shown efficacy of both 10 Hz and 50Hz stimulation frequencies in treating urgency, any performance difference realized at the end of the study is expected to be small.
Concluding message
A successful clinical outcome will expand the use of the ELITONE device beyond its current indication for stress urinary incontinence, providing an opportunity to benefit a broader population of incontinent women. As a non-invasive solution, it offers potential for broader adoption than vaginally inserted solutions, particularly among individuals who are physically, emotionally, or culturally resistant to those solutions. And, in addition to serving as a valuable supplement to in-clinic care, for women with limited access to in-person care it provides an important treatment option where none may previously have existed.