Vivally Clinical Evidence
We conducted several successful multi-site randomized clinical studies to generate robust clinical evidence for Vivally effectiveness, safety and usability.
ReduceOAB — Sham-Controlled Study, 12-weeks, 125 patients
- Vivally Active users had 83.6% success (5 of 6 patients were responders)
- Responder defined by significant reduction in incontinence (≥ 50%) or voids (≥ 30%)
- 49.1% of patients became asymptomatic in one or more symptoms
- Notable daily symptom improvements — 3.73 (Voids) | 2.61 (Leaks) | 3.76 (Urgency)
- Study successful showing Active arm superior to sham (p-value 0.0031)
Patient Perspectives from clinical trials:
- Quality of Life (OAB-q and I-QoL) improvement > 200% over benchmark MCID
- Very high therapy compliance at 92.7%
- Confirmed long-term sustenance of effectiveness with 12 months of clinical data
- Vivally is inherently safe with no device-related serious adverse events
100%
Easy to fit in their daily routine
98.9%
Satisfaction
98.9%
Easy to use
95.6%
Likely to use Vivally to treat OAB
84%
of patients showed improvement in symptoms of urinary frequency, incontinence, and urgency1
92%
of patients reported improved quality of life2
References
1.
Data on file
2.
Goudelocke C, Sobol J, Poulos D, Enemchukwu E, Zaslau S, Dhir R. A Multicenter Study Evaluating the FREquency of Use and Efficacy of a Novel Closed-Loop Wearable Tibial Neuromodulation System for Overactive Bladder and Urgency Urinary Incontinence (FREEOAB). Data On File
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Additionally, Avation Medical has conducted multiple Feasibility Studies, Human Factor Trials, Bench-top Testing and an ongoing real-world registry to validate the technology features, ensure ease of use by patients, system durability and robust Vivally operation under all operating conditions.