Introduction: InTone(TM) (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).
Methods: 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.
Results: 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 %).
Conclusions: Twelve weeks of InTone usage resulted in significant objective and subjective reductions in UI. Device usability was very good.