Physician Information - Atlantic Therapeutics Innovo Instrucciones De Uso

Primary Endpoint
Proportion of Patients who attained significant improvement (50% reduction) in Provocative Pad
Test between Baseline and Week 12
ITT Population/Multiple Imputation
ITT Population/Last Observation Carried Forward
(LOCF)
Key Secondary Endpoints Outcomes for INNOVO
Provocative pad weight test (mean) (grams)
24-hour pad weight test (mean) (grams)
Number of incontinence episodes/day (mean)
Incontinence Quality of Life Questionnaire (I-QOL) (mean)
Number of pads used/day (mean)
Other Secondary Endpoints: Change from Baseline at Week 12 (Observed Case)
Patients who achieved Dryness (<1g
leakage on the provocative pad weight test)
n(%)
Proportion of patients reporting improvement in SUI
Symptoms (Global Impression of Improvement)
Table 1: Overview of Pivotal Study Results
At week 12, 87.2% of the INNOVO
compared to 54.5% at baseline (all of whom had been in the mild category at baseline). The adverse events
(AEs) experienced by subjects were predominantly mild or moderate. No serious device-related adverse events
occurred. The most common device-related adverse event with the INNOVO
followed by medical device pain (4.5%) and skin irritation (3.4%). Most AEs resolved by modifying the stimulation
intensity. No device related urinary tract infections or vaginal infections in the INNOVO
Conclusion: INNOVO
external electrical stimulation device demonstrated clinically meaningful improvements
®
in a range of subjective and objective measures of stress urinary incontinence. The INNOVO
tolerated.
References:
[1] Sand PK, Richardson DA, Staskin DR, Swift SE, Appell RA, Whitmore KE, Ostergard DR. Pelvic floor electrical
stimulation in the treatment of genuine stress incontinence: a multicenter, placebo-controlled trial. Am J Obstet
Gynecol. 1995 Jul;173(1):72-9.
28
: Change from Baseline at Week 12 (LOCF)
®
group were in the dry or mild categories of stress incontinence severity,
®
INNOVO Comparator Device
®
N=89
56.3%
58.4%
-8.48
-13.07
-1.24
13.41
-0.30
17 (19.1%) 29 (31.9%)
70.7%
was device discomfort (9.0%)
®
group were reported.
®
device was well
®
N=91
63.0%
61.5%
-9.66
-9.89
-1.43
15.42
-0.44
63.0%