Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial

Helena Luginbuehl, Corinne Lehmann, Jean-Pierre Baeyens, Annette Kuhn, Lorenz Radlinger, Helena Luginbuehl, Corinne Lehmann, Jean-Pierre Baeyens, Annette Kuhn, Lorenz Radlinger

Abstract

Background: Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.

Methods/design: The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied.

Discussion: This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.

Trial registration: NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.

Figures

Fig. 1
Fig. 1
CONSORT study flow diagram

References

    1. Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011;186(2):589–93. doi: 10.1016/j.juro.2011.03.114.
    1. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4–20.
    1. Luginbuehl H, Baeyens JP, Taeymans J, Maeder IM, Kuhn A, Radlinger L. Pelvic floor muscle activation and strength components influencing female urinary continence and stress incontinence: a systematic review. Neurourol Urodyn. 2015;34(6):498–506. doi: 10.1002/nau.22612.
    1. Deffieux X, Hubeaux K, Porcher R, Ismael SS, Raibaut P, Amarenco G. Abnormal pelvic response to cough in women with stress urinary incontinence. Neurourol Urodyn. 2008;27:291–6. doi: 10.1002/nau.20506.
    1. Shishido K, Peng Q, Jones R, Omata S, Constantinou CE. Influence of pelvic floor muscle contraction on the profile of vaginal closure pressure in continent and stress urinary incontinent women. J Urol. 2008;179(5):1917–22. doi: 10.1016/j.juro.2008.01.020.
    1. Morin M, Bourbonnais D, Gravel D, Dumoulin C, Lemieux MC. Pelvic floor muscle function in continent and stress urinary incontinent women using dynamometric measurements. Neurourol Urodyn. 2004;23:668–74. doi: 10.1002/nau.20069.
    1. Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007;1101:266–96. doi: 10.1196/annals.1389.034.
    1. Dumoulin C, Hay-Smith EJ, Mac Habée-Séguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014;5:CD005654.
    1. Bo K. Pelvic floor muscle training in treatment of female stress urinary incontinence, pelvic organ prolapse and sexual dysfunction. World J Urol. 2012;30(4):437–43. doi: 10.1007/s00345-011-0779-8.
    1. Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213–40. doi: 10.1002/nau.20870.
    1. American College of Sports Medicine American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009;41(3):687–708. doi: 10.1249/MSS.0b013e3181915670.
    1. Güllich A, Schmidtbleicher D. Structure of motor strength and the training methods. Deutsche Zeitschrift für Sportmedizin. 1999;50(7+8):223–34.
    1. Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996;175(1):10–7. doi: 10.1016/S0002-9378(96)70243-0.
    1. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: A brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322–30. doi: 10.1002/nau.20041.
    1. Rotar M, Trsinar B, Kisner K, Barbic M, Sedlar A, Gruden J, et al. Correlations between the ICIQ-UI short form and urodynamic diagnosis. Neurourol Urodyn. 2009;28(6):501–5. doi: 10.1002/nau.20689.
    1. International Consultation on Incontinence Modular Questionnaire (ICIQ). ICIQ Structure Short Form. 2014. . Accessed 14 Oct 2015.
    1. Luginbuehl H, Naeff R, Zahnd A, Baeyens JP, Kuhn A, Radlinger L. Pelvic floor muscle electromyography during different running speeds: an exploratory and reliability study. Arch Gynecol Obstet. 2015, Jul 21. [Epub ahead of print]
    1. Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014;48(4):296–8. doi: 10.1136/bjsports-2012-091880.
    1. Machold S, Olbert PJ, Hegele A, Kleinhans G, Hofmann R, Schrader AJ. Comparison of a 20-min pad test with the 1-hour pad test of the International Continence Society to evaluate post-prostatectomy incontinence. Urol Int. 2009;83(1):27–32. doi: 10.1159/000224864.
    1. Wu WY, Sheu BC, Lin HH. Comparison of 20-minute pad test versus 1-hour pad test in women with stress urinary incontinence. Urology. 2006;68(4):764–8. doi: 10.1016/j.urology.2006.04.018.
    1. Kelleher CJ, Cardozo LD, Khullar V, Salvatore D. A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1997;104(12):1374–9. doi: 10.1111/j.1471-0528.1997.tb11006.x.
    1. International Consultation on Incontinence Modular Questionnaire (ICIQ). ICIQ LUTSquol Module. 2014. . Accessed 14 Oct 2015.
    1. Laycock J, Jerwood D. Pelvic floor muscle assessment: the PERFECT scheme. Physiotherapy. 2001;87:631–42. doi: 10.1016/S0031-9406(05)61108-X.
    1. Fleischmann J, Gehring D, Mornieux G, Gollhofer A. Task-specific initial impact phase adjustments in lateral jumps and lateral landings. Eur J Appl Physiol. 2011;111(9):2327–37. doi: 10.1007/s00421-011-1861-z.
    1. Fleischmann J, Gehring D, Mornieux G, Gollhofer A. Load-dependent movement regulation of lateral stretch shortening cycle jumps. Eur J Appl Physiol. 2010;110(1):177–87. doi: 10.1007/s00421-010-1476-9.
    1. Taube W, Leukel C, Schubert M, Gruber M, Rantalainen T, Gollhofer A. Differential modulation of spinal and corticospinal excitability during drop jumps. J Neurophysiol. 2008;99(3):1243–52. doi: 10.1152/jn.01118.2007.
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007;39(2):175–91. doi: 10.3758/BF03193146.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2. Hillsdale: Lawrence Erlbaum Associates; 1988.
    1. Schulz KF, Altman DG, Moher D. CONSORT Group: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;2010(24):8–18.
    1. Brunner E, Domhof S, Langer F. Nonparametric analysis of longitudinal data in factorial experiments. New York: Wiley; 2002.
    1. Davis CS. Statistical methods for the analysis of repeated measurements. Heidelberg: Springer; 2002.
    1. Kraemer WJ, Adams K, Cafarelli E, Dudley GA, Dooly C, Feigenbaum MS, et al. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2002;34(2):364–80. doi: 10.1097/00005768-200202000-00027.
    1. Bo K, Morkved S. Motor learning. In: Bo K, Berghmans B, Morkved S, van Kampen M, editors. Evidence-based physical therapy for the pelvic floor: bridging science and clinical practice. Edinburgh: Churchill Livingstone; 2007. pp. 113–8.
    1. Winstein CJ. Knowledge of results and motor learning - implications for physical therapy. Phys Ther. 1991;71(2):140–9.
    1. Bo K, Aschehoug A. Strength training. In: Bo K, Berghmans B, Morkved S, van Kampen M, editors. Evidence-based physical therapy for the pelvic floor: bridging science and clinical practice. Edinburgh: Churchill Livingstone; 2007. pp. 119–32.
    1. Kraemer WJ, Ratamess NA. Fundamentals of resistance training: progression and exercise prescription. Med Sci Sports Exerc. 2004;36(4):674–88. doi: 10.1249/01.MSS.0000121945.36635.61.
    1. Chong EC, Khan AA, Anger JT. The financial burden of stress urinary incontinence among women in the United States. Curr Urol Rep. 2011;12(5):358–62. doi: 10.1007/s11934-011-0209-x.
    1. BARMER GEK Heil- und Hilfsmittelreport: Auswertungsergebnisse aus den Jahren 2009 bis 2010 [Therapeutic measures report: Results from 2009–2010]. Schriftenreihe zur Gesundheitsanalyse, Band 10 Claudia Kemper Kristin Sauer Gerd Glaeske 2011 (German)
    1. Luginbuehl H, Greter C, Gruenenfelder D, Baeyens JP, Kuhn A, Radlinger L. Intra-session test-retest reliability of pelvic floor muscle electromyography during running. Int Urogynecol J. 2013;24(9):1515–22. doi: 10.1007/s00192-012-2034-2.
    1. Tomori Z, Widdicombe JG. Muscular, bronchomotor and cardiovascular reflexes elicited by mechanical stimulation of the respiratory tract. J Physiol. 1969;200(1):25–49. doi: 10.1113/jphysiol.1969.sp008680.

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