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InTone: a novel pelvic floor rehabilitation device for urinary incontinence

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Abstract

Introduction

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).

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.

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References

  1. Dumoulin C, Hay-Smith J (2010) Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev 1, CD005654. doi:10.1002/14651858.CD005654.pub2

    PubMed  Google Scholar 

  2. Di Benedetto P, Coidessa A, Floris S (2008) Rationale of pelvic floor muscles training in women with urinary incontinence. Minerva Ginecol 60(6):529–541

    PubMed  Google Scholar 

  3. Bo K (2003) Pelvic floor muscle strength and response to pelvic floor muscle training for stress urinary incontinence. Neurourol Urodyn 22(7):654–658. doi:10.1002/nau.10153

    Article  PubMed  Google Scholar 

  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

    Article  PubMed  Google Scholar 

  5. de Kruif YPVE (1996) Pelvic floor muscle exercise therapy with myofeedback for women with stress urinary incontinence: a meta-analysis. Physiotherapy 82(2):107–113

    Article  Google Scholar 

  6. Weatherall M (1999) Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence: a meta-analysis of trials identified in a systematic review. BJU Int 83(9):1015–1016

    Article  CAS  PubMed  Google 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.CD001407

  8. Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK (2002) Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA 288(18):2293–2299

    Article  PubMed  Google 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/s00192-012-1707-1

  10. Spruijt J, Vierhout M, Verstraeten R, Janssens J, Burger C (2003) Vaginal electrical stimulation of the pelvic floor: a randomized feasibility study in urinary incontinent elderly women. Acta Obstet Gynecol Scand 82(11):1043–1048

    Article  PubMed  Google Scholar 

  11. Shepherd AM, Tribe E, Bainton D (1984) Maximum perineal stimulation. A controlled study. Br J Urol 56(6):644–646

    Article  CAS  PubMed  Google Scholar 

  12. Smith JJ 3rd (1996) Intravaginal stimulation randomized trial. J Urol 155(1):127–130

    Article  PubMed  Google Scholar 

  13. Brubaker L, Benson JT, Bent A, Clark A, Shott S (1997) Transvaginal electrical stimulation for female urinary incontinence. Am J Obstet Gynecol 177(3):536–540

    Article  CAS  PubMed  Google Scholar 

  14. Amaro JL, Gameiro MO, Kawano PR, Padovani CR (2006) Intravaginal electrical stimulation: a randomized, double-blind study on the treatment of mixed urinary incontinence. Acta Obstet Gynecol Scand 85(5):619–622. doi:10.1080/00016340500495058

    Article  PubMed  Google Scholar 

  15. Schmidt AP, Sanches PR, Silva DP Jr, Ramos JG, Nohama P (2009) A new pelvic muscle trainer for the treatment of urinary incontinence. Int J Gynaecol Obstet 105(3):218–222. doi:10.1016/j.ijgo.2009.01.013

    Article  PubMed  Google 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

    Article  CAS  PubMed  Google Scholar 

  17. Laycock JJD (2001) Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy 87:631–642

    Article  Google 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 189–194

    Google Scholar 

  19. Burke J (2013) SUS: A Retrospective. J Usability Stud 8:29–40

    Google 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] 10.1186/1472-6874-6-11

  21. Delgado D, White P, Trochez R, Drake MJ (2013) A pilot randomised controlled trial of the pelvic toner device in female stress urinary incontinence. Int Urogynecol J 24(10):1739–1745. doi:10.1007/s00192-013-2107-x

    Article  PubMed  Google Scholar 

  22. Dumoulin C, Glazener C, Jenkinson D (2011) Determining the optimal pelvic floor muscle training regimen for women with stress urinary incontinence. Neurourol Urodyn 30(5):746–753. doi:10.1002/nau.21104

    Article  PubMed  Google Scholar 

  23. Bo K (2004) Pelvic floor muscle training is effective in treatment of female stress urinary incontinence, but how does it work? Int Urogynecol J Pelvic Floor Dysfunct 15(2):76–84. doi:10.1007/s00192-004-1125-0

    Article  PubMed  Google Scholar 

  24. Knight S, Laycock J, Naylor D (1998) Evaluation of neuromuscular electrical stimulation in the treatment of genuine stress incontinence. Physiotherapy 84:61–71

    Article  Google Scholar 

  25. Dumoulin C, Lemieux MC, Bourbonnais D, Gravel D, Bravo G, Morin M (2004) Physiotherapy for persistent postnatal stress urinary incontinence: a randomized controlled trial. Obstet Gynecol 104(3):504–510. doi:10.1097/01.AOG.0000135274.92416.62

    Article  PubMed  Google Scholar 

  26. Lagro-Janssen TL, Debruyne FM, Smits AJ, van Weel C (1991) Controlled trial of pelvic floor exercises in the treatment of urinary stress incontinence in general practice. Br J Gen Pract 41(352):445–449

    CAS  PubMed Central  PubMed  Google 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.

  28. Yamanishi T, Yasuda K (1998) Electrical stimulation for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9(5):281–290

    Article  CAS  PubMed  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 68:372–373

    Google Scholar 

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Acknowledgments

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).

Funding

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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Authors and Affiliations

  1. Departments of Urology and Obstetrics & Gynecology, Medical College of Wisconsin, 9200 W Wisconsin Ave, Milwaukee, WI, 53226, USA

    Michael L. Guralnick, Holly Kelly, Heather Engelke, Sumana Koduri & R. Corey O’Connor

Authors
  1. Michael L. Guralnick
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  2. Holly Kelly
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  3. Heather Engelke
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  4. Sumana Koduri
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  5. R. Corey O’Connor
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Corresponding author

Correspondence to Michael L. Guralnick.

Appendix 1

Appendix 1

System Usability 424 Scale [18, 19]

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Guralnick, M.L., Kelly, H., Engelke, H. et al. InTone: a novel pelvic floor rehabilitation device for urinary incontinence. Int Urogynecol J 26, 99–106 (2015). https://doi.org/10.1007/s00192-014-2476-9

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  • DOI: https://doi.org/10.1007/s00192-014-2476-9

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