A total of 180 US women with SUI were enrolled in the study comparing INNOVO® to the electrical intravaginal device (iTouch sure®). The goal of the study was to evaluate the non-inferiority of the investigational device over the course of 12 weeks. Mean age of participants was 45.9 years in the INNOVO® group and 47.8 years in the comparator group. Women were instructed to wear the investigational garment for 30 minutes 5 days a week while the comparator device was used for 20 minutes once every day. Researchers evaluated eligibility by MESA questionnaire (score of ≤9 on the urge incontinence) and provocative pad weight test (stress test after bladder filling). Patients who received other SUI therapies were excluded from the trials.
Participants were assessed at baseline, week 4 and week 12 of therapy. After week 12 they were encouraged to perform pelvic floor muscle therapy up to the final visit at week 26. Both groups demonstrated significant improvement in mean urine leakage and quality of life measures.
A total of 50 female participants in Germany were recruited for the double-blind RCT, which assessed the safety and effectiveness of INNOVO® compared to sham. Both devices were prescribed for 30 minutes 5 days a week. Mean age of participants was 51.3 years in the INNOVO® group and 53.0 years in the sham group. MESA questionnaire and Stress Urinary Incontinence Questions (score of at least 18 out of 27) determined subjects’ eligibility.
Participants were evaluated at baseline, week 4, week 12, and week 26 visits. Incontinence-related quality of life was measured up to 12-months. The study showed an overall increase in positive outcomes for the INNOVO® group compared to sham. The insufficient sample size was one of the study limitations because it didn’t produce significant power.
Figure 2 shows the mean change in the quality of life outcomes for both clinical trials:
Data show that INNOVO® is an effective non-invasive treatment option for patients with stress urinary incontinence. Clinical trials demonstrated that it is a low-risk alternative to the standard intravaginal treatment.
Presented by: Catherine Harper, Ph.D. Atlantic Therapeutics
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania, Twitter: @AStambakio at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Winter Meeting, SUFU 2019, February 26 - March 2, 2019, Miami, Florida
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Roger R. Dmochowski, M.D., MMHC, Professor, Department of Urologic Surgery, Vice Chair for Faculty Affairs and Professionalism, Section of Surgical Sciences, Associate Surgeon-in-Chief, Vanderbilt University Medical Center.