Hypothesis / aims of study
Although vaginal pessaries are widely used in the conservative management of urogynecologic conditions, access to their fitting and ongoing follow-up often remains limited. Over-the-counter (OTC) vaginal support devices may offer a more accessible alternative for conservative management of stress urinary incontinence and pelvic organ prolapse. Current theories attribute the efficacy of these devices to mechanical support of pelvic structures or their space-occupying properties; however, the neuromuscular effects of vaginal support devices on pelvic floor muscles have not been investigated.
The aim of this study was to evaluate the acute neuromuscular effects of an OTC vaginal support device, the Pippa (non-significant risk), on the levator plate angle (LPA) and puborectalis muscle stiffness during rest, maximal voluntary contraction (MVC), and maximal bearing down, in asymptomatic women. We tested the null hypothesis that insertion of the device would not change the LPA or puborectalis muscle stiffness in the three contraction states tested.
Study design, materials and methods
A single-group, pre–post mechanistic study was conducted in fifteen asymptomatic women aged 20–39 years. Transperineal B-mode ultrasound and shear wave elastography (SWE) were used to assess pelvic floor neuromuscular function with and without the Pippa device inserted. Imaging was performed in supine hooklying; order was randomized for device condition and imaging modality.
Participants performed three standardized tasks: rest, contraction, and bearing down. LPA was measured from the inferior pubic point to the anorectal angle relative to a horizontal reference line [1]. Puborectalis muscle stiffness was quantified in kilopascals (kPa) using SWE with standardized regions of interest [2].
Two-way repeated measures ANOVAs examined the interaction effects of the device and contraction state. Pairwise comparisons were used to compare mean differences. Additionally, change scores from rest to contraction and rest to bearing down were analyzed to normalize changes to resting muscle tone once the device was inserted.
Interpretation of results
The device did not restrict or enhance expected elevation or depression of the pelvic floor in asymptomatic women, supporting its functional compatibility with normal pelvic floor mechanics. The observed increase in puborectalis muscle stiffness during bearing down suggests a neuromuscular effect that may reduce excessive tissue deformation during tasks with increased intraabdominal pressure. The decrease in stiffness during contraction while wearing the device is not well understood; it may be related to offloading the pelvic floor muscles or potential changes to the length-tension relationship of pelvic floor muscles when using the device.
These findings expand the current mechanistic understanding of vaginal support devices beyond structural support models to include potential neuromuscular modulation of the pelvic floor muscles while maintaining functional range of motion.