Physician Information - Atlantic Therapeutics Innovo Instrucciones De Uso

PHYSICIAN INFORMATION

CLINICAL STUDIES
Pilot Study
Fourteen (14) patients with stress urinary incontinence (SUI) completed a 12-week training program using a
neuromuscular electrical nerve stimulation (NMES) device which was an earlier version of the INNOVO device.
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The results showed a reduction in the mean urine leakage on the 1-hour and 24-hour pad weight tests from
baseline to week 12, and improvements in quality of life and the number of incontinence episodes per day.
Randomized Clinical Studies
Two randomized clinical trials were performed. The first was a sham-controlled trial conducted in Germany of fifty
women with mixed incontinence that was prematurely terminated due to the commencement of the second trial.
The second was an active-controlled, US, randomized, non-inferiority trial that included 180 adult women with
stress urinary incontinence.
Trial 1: German Sham-Controlled Trial
Fifty (50) female German subjects with predominantly stress UI were randomized into two groups; many subjects
had mixed incontinence and some subjects were enrolled who had severe urge incontinence as part of an overall
severe mixed incontinence. All subjects had previously failed a 6-week volitional pelvic floor muscle training
program or an equivalent lifestyle and exercise program. The mean ages were 51-53 years across treatment
groups.
Subjects in the active group (n=24) used an active stimulation device, while subjects in the control group (n=26)
received treatment with a modified device. The modified device was programmed to produce a lower dose of
stimulation with a sensory response. The active device used in this study was an earlier version of the Innovo
device.
Treatment was comprised of a 30-minute session of stimulation, in a standing position, 5 days per week, for 12
weeks.
At week 12, the mean reduction from baseline in urine leakage using the one-hour pad weight test was 22.55
grams in the active group versus 17.65 grams in the control group. A greater improvement from baseline was also
observed for the I-QOL in the active group. The one-hour provocative pad weight test showed improvement in
the percentage of subjects who experienced at least a 50% reduction in pad weight for the treatment over control
at 12 weeks (75% treatment versus 47% control). The 24-hour pad weight measures for treatment and control at
12 weeks showed no significant difference for the same outcome measure (44% treatment versus 41% control).
However, there was a greater improvement in the 24- hour pad weight results for the active group versus the
control group at week 12 where the mean reduction in urine leakage was as 26.54 gms for the active device and
6.6 gms for the control.
Results of this randomized, controlled, double-blind, clinical study showed greater magnitude of change in the 1-
hour pad test for subjects using the active device compared to the control device after 12 weeks of treatment.
The device had few side effects.
References
1. Brown CA. Literature review: Does neuromuscular electrical stimulation increase pelvic floor muscle strength
in women with urinary incontinence with an ineffective pelvic floor contraction? Journal of the Association of
Chartered Physiotherapists in Women's Health, Spring 2014, 114, 56–62.
2. Mørkved S, Bø K, Fjørtoft T. Effect of adding biofeedback to pelvic floor muscle training to treat urodynamic
stress incontinence. Obstet Gynecol. 2002;4:730–739.
3. Alves PG, Nunes FR, Guirro EC. Comparison between two different neuromuscular electrical stimulation
protocols for the treatment of female stress urinary incontinence: a randomized controlled trial. Rev Bras Fisioter.
2011;5:393–398.
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