Impact of a Digital Therapeutic Device on Pelvic Floor Symptoms.

Abstract

Importance: Women undergoing treatment for urinary incontinence (UI) often have additional pelvic floor disorders (PFDs). It is important to understand the effect of UI-focused pelvic floor muscle training (PFMT) on other PFDs.

Objective: The objective of this analysis was to evaluate the prevalence of symptoms of pelvic organ prolapse (POP) and fecal incontinence (FI) in women treated for UI, and symptom changes following pelvic floor muscle training (PFMT) with and without a motion-based biofeedback device (MBBD).

Study design: This was a post-hoc analysis of a randomized controlled trial comparing PFMT with and without an MBBD in women with UI. Symptomatic PFDs were defined using Pelvic Floor Distress Inventory-20 (PFDI-20) subscales, the Urogenital Distress Inventory Short Form (UDI-6), Colorectal Anal Distress Inventory-8 (CRADI-8), and the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6). Outcomes included the prevalence of multiple PFDs and change in UDI-6, CRADI-8, and POPDI-6 scores among participants with and without concomitant PFDs.

Results: A total of 299 women were analyzed. Of 299 women, 161 (57%) reported symptoms of more than 1 PFD. Age and body mass index did not differ. Baseline UDI-6 scores were higher in those with additional PFD symptoms versus UI alone (45.7 ± 15.8 vs 60.7 ± 19.4, P < 0.001). For participants with UI plus at least 1 additional PFD symptom, improvement in UDI-6 scores at 6 and 12 months was significantly greater in the intervention group. For participants with FI, the CRADI-8 was significantly improved from baseline to 8 weeks, 12 months, and 24 months. For participants with POP symptoms, the POPDI score was significantly improved at all time points.

Conclusions: Pelvic floor muscle training is effective in treating UI in the context of additional PFDs, as well as in treating symptoms of FI and POP.