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A randomized controlled trial

Randomized Controlled Noninferiority Trial Versus Intravaginal Electrical Stimulation

Novel External Electrical Muscle Stimulation Device For The Treatment Of Female Stress Urinary Incontinence

Most electrical muscle stimulation devices for the treatment of stress urinary incontinence use transvaginal electrical stimulation. INNOVO® is a novel, non-invasive, external electrical muscle stimulation device for the treatment of incontinence.

The aim of this study was to compare the effcacy and safety of the INNOVO® external electrical muscle stimulation device with an FDA- cleared intravaginal device (itouch sure) for the treatment of stress urinary incontinence in women

Objective
A prospective, randomized, single-blind, multicenter, noninferiority study performed at 12 sites in the USA. Women with predominant stress urinary incontinence whose condition had not improved using pelvic floor muscle training were randomized to undergo treatment with either an INNOVO® or control device for 12 weeks.

Method
Treatment was administered by the subjects at home using the device
in accordance with the relevant instructions for use, which speci ed that the INNOVO® device was used for 30 minutes once daily for 5 days/week, and the control device was used for 20 minutes once daily every day.

Primary Endpoint
At week 12 a “significant improvement” in the provocative pad weight test was seen in most subjects in both the INNOVO® group (56.3%) and the control group (63.0%), although noninferiority was not established because the lower bound of the 95% confidence interval for the treatment difference did not exceed the -5% noninferiority margin (difference -6.7%, 95% CI -21.7% to 8.4%).

Secondary Endpoint
Statistically significant improvements from baseline in mean urine leakage in the provocative pad weight test and 24-hour pad weight test, number of incontinence episodes and pads used per day, and I-QOL score were seen with both devices at week 12

Results
At week 12, 87.2% of the INNOVO® group and 86.8% of the control group were in the dry or mild categories of stress incontinence severity representing an improvement of 32.7% for INNOVO® and 26.1% for the control group .

Adverse Events
Adverse events were predominantly mild or moderate. No serious device- related adverse events occurred. Few subjects discontinued the study due to adverse events (INNOVO® 3.4%, Control device 4.4%)

Conclusion

The two devices provided broadly similar, clinically meaningful, improvements in a range of subjective and objective measures of stress urinary incontinence. Noninferiority versus the control group was not established for the primary endpoint, possibly in part because of underpowering. Both devices were well tolerated. INNOVO® was associated with fewer infections than the probe based control group. Compliance with treatment appeared to be better with the INNOVO®.

For further information contact Roger Dmochowski on roger.dmochowski@Vanderbilt.Edu

SEE STUDY

Author
Roger Dmochowski, Vanderbilt University, Catherine M. Lynch, University of South Florida, Mitchell Efros, AccuMed Research Associates, Linda Cardozo, King’s College Hospital, London.

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