InTone: a novel pelvic floor rehabilitation device for urinary incontinence
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InToneTM (InControl Medical) is a nonimplanted vaginal device providing biofeedback and electrical stimulation of pelvic floor muscles. The purpose of this study was to assess its efficacy and usability for treating urinary incontinence (UI).
Women with UI (stress, urge, mixed) were recruited for this pilot trial. InTone was used 5–6 days a week for 12 weeks. Patients were assessed at baseline and monthly with symptom questionnaires [Urinary Distress Index (UDI6), Incontinence Impact Questionnaire (IIQ7)], bladder diaries. and 24-h pad-weight testing (PWT). Efficacy was assessed by comparing 12-week results to baseline values using chi-square and Wilcoxon rank-sum tests. Usability was assessed with a device-usage log and the System Usability Scale (SUS), which evaluates patients’ global impression of usability.
Thirty-three women were enrolled; five patients withdrew and were excluded. Median age was 50 years (range 35–69). After 12 weeks of InTone therapy, median UDI6 and IIQ7 scores improved from 50.0 to 29.2 (p < 0.001) and from 42.9 to 14.3 (p < 0.001), respectively. Statistically significant reductions in median PWT (35.5–4.6 g, p < 0.001), median daily pad use (4.0–2.0, p < 0.001), and median daily incontinence frequency (4.3–1.0, p < 0.001) were noted; 68 % of patients achieved a > 50 % reduction in daily pad usage and PWT. Device usability was good, with a median SUS of 86.3 and a median expected use of 107 % (33–140 %).
Twelve weeks of InTone usage resulted in significant objective and subjective reductions in UI. Device usability was very good.
KeywordsBiofeedback Electrical stimulation Pelvic floor muscles Urinary incontinence
We thank Dan Eastwood for statistical support.
Conflicts of interest
M.L. Guralnick, Astellas (speaker bureau), Allergan (speaker bureau), InControl Medical (research funding).
H. Kelly, none.
H. Engelke, none.
S. Koduri, none.
R.C. O’Connor, Astellas (speaker bureau).
InControl Medical provided funding for this study: devices provided free of charge, costs related to clinic visits/lab charges, costs for statistical analysis (Department of Biostatistics, Medical College of Wisconsin). No direct payment was made to individual study investigators.
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