For a study, researchers sought to see if pelvic floor muscle training using a motion-based digital intravaginal device was more helpful than home pelvic floor muscle training for stress or stress-predominant mixed urine incontinence (UI). Women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program with written and narrated instructions in a remote, virtually executed 8-week prospective randomized controlled superiority trial. On a 3-day bladder diary, the primary outcomes were changes in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) events. To achieve the power analysis criteria for the UDI-6 score (n=278) and the bladder diary (n=78), a sample size of 139 per group (n=278) was proposed. Secondary endpoints that were predetermined were quality-of-life questionnaires and adherence reports.
From September 2020 to March 2021, 5,353 people were screened, and 363 were randomly assigned to one of two groups: 182 in the intervention group and 181 in the control group. There were no variations in clinicodemographic characteristics across groups at the outset. The intervention group’s mean change in UDI-6 score was considerably bigger than the control group’s (18.8 vs 14.7, P=.01). The intervention group’s median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly decreased from 5 (3–8) to 1 (0–3) and 2 (1–4) (P=.005) compared to the control group. On the PGI-I (Patient Global Impression of Improvement), a significantly higher proportion of participants in the intervention group than in the control group reported being “much improved” or “very much improved” (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21–3.15). There were no serious adverse events associated with the device. When compared to a home training program, pelvic floor muscle training led by a motion-based digital therapy device resulted in considerably reduced UI symptoms and a reduction in UI episodes in the all-remote, virtually performed an experiment.
Reference:journals.lww.com/greenjournal/Fulltext/2022/04000/Digital_Therapeutic_Device_for_Urinary.17.aspx
