Atlantic Therapeutics Innovo Instrucciones De Uso página 27

Trial 2: Pivotal USA Trial
Aims of study: The aim of this study was to compare the efficacy and safety of the Innovo® external electrical
muscle stimulation device with an FDA-cleared intravaginal stimulation device (comparator device) for the
treatment of SUI in women.
Study design: This was a prospective, randomized, single-blind, multicenter, non-inferiority study performed at
12 sites in the USA. The study sample size was 180 patients.
Women with stress predominant UI whose condition had not improved using pelvic floor muscle training were
randomized to undergo treatment with either the INNOVO
the study, women with mixed UI could not have had severe urge incontinence.
Eighty-nine (89) women were randomized into the INNOVO
group.
Baseline incontinence characteristics were similar between the groups. The mean age for subjects included in
the study was 45.9 years and 47.8 years for the INNOVO
subjects were premenopausal (61.1%). The mean BMI was 27.52 kg/m2.
Treatment was administered by the subjects at home using the device in accordance with the relevant instructions
for use, which specified that the INNOVO
comparator device was used consistent with its labeling.
Study endpoints: The primary endpoint was the proportion of subjects who achieved "significant improvement"
(>50% reduction in pad weight from baseline) in the provocative pad weight test at 12 weeks.
Key secondary efficacy endpoints included:
• The mean change from baseline to week 12 for urine leakage in the provocative pad weight test,
• 24-hour pad weight test,
• Number of incontinence episodes/day,
• Incontinence Quality of Life questionnaire (I-QOL) score,
• Number of pads used/day,
• The proportion of patients achieving dryness (<1 g on the provocative pad weight test) at week 12.
Safety was also assessed.
Results:
For the primary effectiveness endpoint of the proportion of patients that had significant (at least 50%)
improvement in the 1-hour provocative pad weight test (Table 1), the Innovo treatment arm failed to demonstrate
non-inferiority against the active comparator device based on the pre-specified 5% non-inferiority margin for the
primary outcome. Overall, the primary outcome of 56.3 percent of the patients experiencing a clinically significant
(at least 50% reduction in one-hour provocative pad weight) is clinically meaningful. The Innovo performed
numerically better than the active comparator for two of the seven secondary endpoints, the Global Impression of
Improvement and the 24-hour pad weight test. The INNOVO
urine leakage in the provocative pad weight test, 24-hour pad weight test, number of incontinence episodes,
pads used per day, and I-QOL score at week 12 (Table 1).
or comparator device for 12 weeks. To be enrolled in
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group and 91 women to the comparator device
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and comparator groups, respectively. The majority of
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device was used for 30 minutes once daily for 5 days/week, and the
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demonstrated improvements from baseline in mean
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