Motion-based digital device allows effective self-management of urinary incontinence

Use of a motion-based digital device to guide pelvic floor muscle training effectively mitigates symptoms of urinary incontinence (UI) as well as reduces UI episodes relative to a home training program that consists of written and narrated instructions, as shown in a study.

In a cohort of 363 women with stress or stress-predominant mixed UI, those who used the device (intervention; n=182) showed larger improvements in urinary symptom severity and degree of bother as measured using the Urogenital Distress Inventory Short Form (UDI-6; 18.8 vs 14.7; p=0.01) in comparison with those who underwent a home training program (control; n=181). [Obstet Gynecol 2022;139:606-615]

Moreover, the use of the device led to a greater reduction in the number of SUI episodes on the 3-day bladder diary, from a median of 5 episodes to 1 as compared to a median of 5 episodes to 2 with the control (p=0.005).

Significantly more women in the intervention group than in the control group reported that their symptoms were “much better” or “very much better” on the Patient Global Impression of Improvement (PGI-I; 44.1 percent vs 28.8 percent; odds ratio, 1.94, 95 percent confidence interval [CI], 1.21–3.15). Finally, there were no device-related severe adverse events.

“This study demonstrates the efficacy and safety of a motion-based digital therapeutic device … for women with stress UI and stress-dominant mixed UI, yielding superior results compared with a home program of written and verbal instructions,” according to investigators from the Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, US.

“Additionally, the device enables remote monitoring of adherence to pelvic floor muscle training, which offers a new opportunity for obstetrician-gynecologists to monitor and engage with patients during first-line care,” they added.

Pelvic-floor muscle exercises done the right way

Pelvic-floor muscle rehabilitation, such as Kegel exercises and vaginal weight training, is first-line nonpharmacological treatment for UI and its subtypes. While having been shown to improve and resolve UI symptoms, the treatment approach’s uptake and adherence remain suboptimal due to inadequate patient knowledge about how to perform the exercises and limited access to care owing to a deficit of skilled professionals (ie, physical therapists, continence nurse specialists). [Menopause 2018;25:29-37; Curr Urol Rep 2016;17:10-17; Neurourol Urodyn 2020;39:863-870; Neurourol Urodyn 2015;34:622-631]

The current motion-based digital device promises to help women strengthen their pelvic floor muscles to help treat urinary leakage by facilitating correct execution of the exercises. A small, flexible vaginal insert that takes the shape of the vagina when placed, the device integrates accelerometers that keep track of the motion of the vagina when pelvic floor muscles are contracted. It is paired with a smartphone app, which features real-time interactive visualization technology so the users can optimize their pelvic floor muscle training.

In the study, “mean UDI-6 improvement reached statistical significance for both groups by 4 weeks, with the intervention arm significantly more improved than the control arm at both 4 and 8 weeks… [The women who used the device] met or exceeded the minimum clinically important difference of 11 points at both the 4- and 8-week timepoints, whereas the control group met the minimum clinically important difference at 4 weeks but not again at 8 weeks,” the investigators noted.

The device succeeded in that “early and continued symptom improvement may enhance patient self-efficacy regarding pelvic floor muscle training and positively influence adherence to treatment over time,” they added.

According to the investigators, a longer-term follow-up is underway and that its results will serve to better understand the durability of the treatment regimen and evaluate the need for maintenance exercises to maintain the benefits of therapy.

The current study was limited by the inability to conduct a physical examination prior to enrolment, as the trial was conducted virtually.