Aims: This study aimed to evaluate the initial efficacy, safety, and usability of a novel, dynamic, and disposable intravaginal device in women suffering from stress urinary incontinence (SUI).
Methods: Twenty-six women with SUI were recruited to perform a modified 1-h Pad Weight Gain (PWG) test. In this test, women drank 250-500 ml of water, were given a pre-weighed pad, and asked to perform a set of incontinence-inducing activities. At the end of the activities session, the pad was removed and weighed. This test was performed both with and without the Nolix device. Three efficacy endpoints measured were continuous percent reduction in urine leakage, dryness (defined as pad weight increase by no more than 1 g), and improvement in pad weight (measured as continuous percent reduction in PWG ≥ 50%). Any adverse events, reported by subjects during the device use were recorded. The usability and user's satisfaction were assessed using the Benefit, Satisfaction, and Willingness to Continue and Nolix Satisfaction questionnaires.
Results: The average reduction in PWG was 79.4%. The average reduction in urine leakage while using the device was at least 70%. In addition, in 79.5% of tests, the clinically meaningful level of improvement in PWG was achieved. Use of the device produced substantial improvement in the patient's perceived quality of life. No adverse events were reported during the study.
Conclusion: The Nolix device served as a noninvasive, effective, and well-tolerated treatment option for reducing SUI in a modified 1-h PWG test with a set of incontinence-inducing activities.
Trial registration: ClinicalTrials.gov NCT04325477.
Keywords: intrauterine device; stress urinary incontinence.
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