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Clinical Evidence for leva®
- In a 6-week open-label study of 23 women using the first-generation leva, more than 50% of women saw clinically significant symptom improvement by week 1.1
- 87% of women reported no leakage by week 6.1*
- All women expressed improvement in condition-specific quality of life by the end of the study.1†
* Women with Stress Urinary Incontinence (SUI) or Mixed Urinary Incontinence (MUI).
† The referenced clinical results are based on a 6-week open-label study conducted in 2017 of 23 women who used the first-generation leva Pelvic Digital Health System. While we believe the next-generation leva Digital Therapeutic would have similar results, we do not have clinical data to establish that this would have occurred. We are currently finalizing the study results from a 2019 pilot randomized controlled trial of the next-generation leva Digital Therapeutic and will publish those results as soon as approved. For the full published results of the 2017 study, see reference 1.
The UDI-6 score decreased from 27.5±16.9 at baseline to 1.1±2.9% at 6 weeks (of 100% maximum possible; p<.0001, repeated measures ANOVA and paired t-test).
Urogenital Distress Inventory – Short Form (UDI-6) measures overall symptom distress.2
The mean IIQ-7 score decreased from 17.6±21.6 points at baseline to 0.2±1.0 points through 6 weeks (100 points=maximal negative impact; p=.0009). Shown in charts are means with 95% confidence intervals, and stated in text are means ± SD.
Incontinence Impact Questionnaire – Short Form (IIQ-7) measures life impact associated with urinary incontinence, including physical activity, travel, social activities, and emotional health.2
1. Rosenblatt P, McKinney J, Rosenberg RA, Iglesias RJ, Sutherland RC, Pulliam SJ. Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study. Neurourology and Urodynamics. 2019;1-9. https://doi.org/10.1002/nau.24097
2. Uebersax JS, Wyman JF, Shumaker SA, et al. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14:131–9