Clinical Evidence for leva®

Clinical Evidence for leva®

Clinical Evidence

  • In a 6-week open-label study of 23 women, the leva Pelvic Digital Health System improved patient-reported urinary incontinence (UI) symptom severity and condition-specific quality-of-life, beginning at one week of use. Pelvic floor muscle performance also improved.1
  • 20 women had significant symptom improvement within 3 weeks (87%), 17 women reported no leakage by the 6th week (74%), and all 23 women expressed improvement in condition-specific quality-of-life by the end of the study (100%).1
  • Three women experienced adverse events including cold symptoms, suspected urinary tract infection (culture negative), and migraine headaches. All resolved without complications.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. 3

Clinical Evidence

  • In a 6-week open-label study of 23 women, the leva Pelvic Digital Health System improved patient-reported urinary incontinence (UI) symptom severity and condition-specific quality-of-life, beginning at one week of use. Pelvic floor muscle performance also improved.1
  • 20 women had significant symptom improvement within 3 weeks (87%), 17 women reported no leakage by the 6th week (74%), and all 23 women expressed improvement in condition-specific quality-of-life by the end of the study (100%).1
  • Three women experienced adverse events including cold symptoms, suspected urinary tract infection (culture negative), and migraine headaches. All resolved without complications.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. 3

1. Renovia Inc (2018) Rosenblatt P, Rosenberg RA, Cermak J, Iglesias RJ, Sutherland RC, McKinney JL and Pulliam SJ.Interactive pelvic floor muscle training for female urinary incontinence. Available at here. ; 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.; 3. 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

1. Renovia Inc (2018) Rosenblatt P, Rosenberg RA, Cermak J, Iglesias RJ, Sutherland RC, McKinney JL and Pulliam SJ.Interactive pelvic floor muscle training for female urinary incontinence. Available at here. ; 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.; 3. 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