InTone: a novel pelvic floor rehabilitation device for urinary incontinence
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
- 4.Dannecker C, Wolf V, Raab R, Hepp H, Anthuber C (2005) EMG-biofeedback assisted pelvic floor muscle training is an effective therapy of stress urinary or mixed incontinence: a 7-year experience with 390 patients. Arch Gynecol Obstet 273(2):93–97. doi:10.1007/s00404-005-0011-4 PubMedCrossRefGoogle Scholar
- 7.Hay-Smith EJ, Bo Berghmans LC, Hendriks HJ, de Bie RA, van Waalwijk van Doorn ES (2001) Pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev (1):CD001407. doi:CD001407 [pii] 10.1002/14651858.CD001407Google Scholar
- 9.Fitz FF, Resende AP, Stupp L, Sartori MG, Girao MJ, Castro RA Biofeedback for the treatment of female pelvic floor muscle dysfunction: a systematic review and meta-analysis. Int Urogynecol J 23 (11):1495–1516. doi:10.1007/s00192-012-1707-1Google Scholar
- 16.Imamura M, Abrams P, Bain C, Buckley B, Cardozo L, Cody J, Cook J, Eustice S, Glazener C, Grant A, Hay-Smith J, Hislop J, Jenkinson D, Kilonzo M, Nabi G, N'Dow J, Pickard R, Ternent L, Wallace S, Wardle J, Zhu S, Vale L (2010) Systematic review and economic modelling of the effectiveness and cost-effectiveness of non-surgical treatments for women with stress urinary incontinence. Health Technol Assess 14(40):1–188. doi:10.3310/hta14400 PubMedCrossRefGoogle Scholar
- 18.Brooke J (1996) SUS: A “quick and dirty” usability scale. In: Jordan PW, Thomas B, McClelland IL, Weerdmeester B (eds) Usability evaluation in industry. Taylor & Francis, London, pp 189–194Google Scholar
- 19.Burke J (2013) SUS: A Retrospective. J Usability Stud 8:29–40Google Scholar
- 20.Neumann PB, Grimmer KA, Deenadayalan Y (2006) Pelvic floor muscle training and adjunctive therapies for the treatment of stress urinary incontinence in women: a systematic review. BMC Womens Health 6:11. doi:1472-6874-6-11 [pii] 10.1186/1472-6874-6-11Google Scholar
- 27.American College of Sports Medicine Position Stand (1990). The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness in healthy adults. Med Sci Sports Ex, vol 22.Google Scholar
- 29.Bidmead JMJ, Cardozo L, Hextall A, Boos K (2002) Home electrical stimulation in addition to conventional pelvic floor exercises: a useful adjunct or expensive distraction? NeurourolUrodyn 68:372–373Google Scholar