Hypothesis / aims of study
Stress urinary incontinence (SUI) is a global phenomenon that affects up to 40% of women and has a negative social and economic impact [1,2]. Although surgical options are available, an effective, non-invasive alternative is needed. Nolix™ is a novel tampon-like, single-use, disposable intravaginal device, made of a soft and flexible silicon, developed for the management of SUI. It is intended to transiently exert pressure on the urethra in response to increased intra-abdominal pressures, managing continence episodes. The objective of this study is to evaluate the effectiveness and safety of the Nolix™ device when used for the management of SUI in women. In addition, the study is aimed to evaluate changes in the quality of life (QOL) during use of the device.
Study design, materials and methods
This study is an open-label, prospective, single-arm study, with the Nolix™ device used in women with SUI, serving as their own controls. The primary efficacy endpoint is percentage of pad weight gain (%PWG) during 14 consecutive days of device use as compared to control (pre-device) 7-day period, with success defined as at least > - 50% of the mean %PWG change between both periods. Additional efficacy endpoints include change in number of self-reported incontinence episodes per week, as well as the changes in QOL, leak scores and overall satisfaction levels. The safety of the device is evaluated by assessing adverse events (AEs).
Results
Thirty-four patients enrolled and 14 completed 14 days of device use. A 50% reduction in PWG was measured in 78.6% of subjects. Self-reported incontinence episodes per week decreased from 4.0 + 2.3 episodes to 1.6 + 1.6 during Nolix™ use with improvement in the patient’s perceived QOL. With regards to the overall subjects’ feedback on the QOL before and after the device use using the IIQ-7 Questionnaire, no significant differences were observed. Leak Score Questionnaire scores significantly deceased in average of 8.4 points, from 15.8 ± 11.7 at the pre-Nolix™ phase to 7.4 ± 7.4 points following the Nolix™ use.
Eighteen AEs were reported, all were classified as non-serious AEs. Seven of these (33.3%) were related to the use of Nolix™ device and included discomfort and/or pain during device insertion, vaginal itching, irritation and discomfort while using the device and mild vaginal spotting.
Interpretation of results
The Nolix™ device resulted in a reduction in urinary incontinence, as compared to women’s baseline condition. Almost 79% of women achieved a 50% PWG reduction from the control period to the days of device usage. There was a significant reduction in urinary incontinence episodes per week between the two periods. With regards to safety, the Nolix™ device had an acceptable safety profile and no serious AEs were reported.