Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence (UI) is a substantial barrier to exercise. As many as one in three females with UI report that they limit their physical activity due to incontinence: 11.6% by not exercising at all, 11.3% by exercising less and 12.4% by changing the type of exercise they perform. It is imperative to look for alternatives to manage this condition, as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life. While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running.

Urinary incontinence (UI) is a serious public health concern, imposing a significant financial burden. In Canada the direct and indirect health costs associated with UI total over 3.6 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life. Although the primary risk factor for UI is pregnancy and vaginal delivery, it was recently reported that between 20% and 40% of nulliparous females report urine leakage when they engage in physical activity. Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure. This is accomplished through a complex combination of mechanisms, including smooth and striated urethral sphincter muscle action, urethral venous engorgement and mucous secretions within the urethra, and the proper transfer of loads to the urethra, which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle (PFM) action. The associations among physical activity, pelvic floor morphology and function, and UI are not clear. A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction. Exercise at mild to moderate intensity appears to be protective, decreasing both the odds and the risk of experiencing urinary incontinence. However, females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise, thus chronic and repetitive loading of the pelvic floor may have negative consequences. While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations, no study has investigated about interventions specific to running-induced UI.

exercise-induced urinary incontinence, running-induced urinary incontinence, intravaginal pessary, tampon, pelvic floor

Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 12-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over. Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them.

Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 12-week period. The tampon should be used only while running and removed and discarded when the training is over.

Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 12-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. After 12-weeks, they will be reassessed and will be offered the opportunity to receive a pessary if they desire so.

Participants will receive a 3-size fitting kit and will fit the appropriate size based on manufacturer instruction. Once the size is verified, the participants will be asked to use the pessary while running over a 12-week period.

Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 12-week period.

Participants will be provided with a pre-weighed pad to attach to their underwear and wear it while running for 30 minutes on the treadmill. Once they finish running, the pad will be weighted again to record urine leakage. This will be done at the baseline and after 12-weeks.

Participants will be asked to complete a bladder diary recording leakage experiences during each running session over a two-week period before their first lab assessment and over a two-week period again beginning in the tenth week after starting the protocol. They will receive daily reminders to fill it out.

The Brisk walking and Running lower Urinary Tract Symptoms Questionnaire evaluates the symptoms and management strategies associated with urinary urgency and urinary incontinence that occurs during brisk walking, jogging, and running. Participants will be asked to complete it before coming for their first lab assessment and after 12-weeks. The questionnaire has 4 domains: (1) about urgency symptoms, (2) about urgency urinary incontinence (UUI), (3) about stress urinary incontinence (SUI) and (4) about symptoms management. Scores are all 0-100 and higher scores mean a worse outcome with regards to the impact of lower urinary tract symptoms. The total score is still out of 100 (Urgency + UUI + SUI + Management / 4).

Participants will be asked to rate their overall impression of how much the symptoms improved with the intervention on a scale of 0 to 100 after 12-weeks. Higher scores mean a better outcome = more improvement.

Participants will be asked to rate their satisfaction with the intervention on a scale of 0 to 100 after 12-weeks. Higher scores mean a better outcome = more satisfied.

Adherence to the interventions will be logged through weekly e-mail contact, followed up with telephone contact if there is no response to the e-mail.

Adverse events (bleeding, vaginal discharge, pain, etc.) will be assessed through weekly e-mail contact, followed up with telephone contact if there is no response to the e-mail.

Changes in bladder neck height will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill.

Changes in levator hiatus area will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill.

Changes in levator plate lenght will be assessed by Ultrasound imaging at baseline and after 12-weeks. The images will be recorded before and after a 30-minute running protocol on a treadmill.

Changes in pelvic floor muscle strength will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill.

Changes in pelvic floor muscle stiffness will be assessed at baseline and after 12-weeks using an intravaginal dynamometer. The measures will be recorded before and after a 30-minute running protocol on a treadmill.

Inclusion Criteria: Cis-females aged 18 years and over who run at least 5 km in under 50 minutes (minimum speed of 6 km/h to ensure high impact), at least twice per week (to ensure adequate frequency), and who have done so for at least one year (to ensure adequate duration of exposure); Who regularly (≥ 1 per week) experience urine leakage while running and who report ≤1 urine leakage episode per month not associated with exercise; Exclusion Criteria: Any risk factors related to exercise; If they report any pain or musculoskeletal injury at the time of the screening; History of urogenital surgery; Symptoms of the female athlete triad; Dyspareunia to the extent that they cannot undergo a regular gynaecologic examination; Have a known neurologic disorder (e.g. stroke, multiple sclerosis); Pregnancy or partum within the previous year;

Herschorn S, Gajewski J, Schulz J, Corcos J. A population-based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey. BJU Int. 2008 Jan;101(1):52-8. doi: 10.1111/j.1464-410X.2007.07198.x. Epub 2007 Oct 1.

Almousa S, Bandin van Loon A. The prevalence of urinary incontinence in nulliparous adolescent and middle-aged women and the associated risk factors: A systematic review. Maturitas. 2018 Jan;107:78-83. doi: 10.1016/j.maturitas.2017.10.003. Epub 2017 Oct 7.

Windle G, Hughes D, Linck P, Russell I, Woods B. Is exercise effective in promoting mental well-being in older age? A systematic review. Aging Ment Health. 2010 Aug;14(6):652-69. doi: 10.1080/13607861003713232.

Sun F, Norman IJ, While AE. Physical activity in older people: a systematic review. BMC Public Health. 2013 May 6;13:449. doi: 10.1186/1471-2458-13-449.

Nygaard I, Girts T, Fultz NH, Kinchen K, Pohl G, Sternfeld B. Is urinary incontinence a barrier to exercise in women? Obstet Gynecol. 2005 Aug;106(2):307-14. doi: 10.1097/01.AOG.0000168455.39156.0f.

Smith AR, Hosker GL, Warrell DW. The role of pudendal nerve damage in the aetiology of genuine stress incontinence in women. Br J Obstet Gynaecol. 1989 Jan;96(1):29-32. doi: 10.1111/j.1471-0528.1989.tb01572.x.

Ree ML, Nygaard I, Bo K. Muscular fatigue in the pelvic floor muscles after strenuous physical activity. Acta Obstet Gynecol Scand. 2007;86(7):870-6. doi: 10.1080/00016340701417281.

Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.

Ashton-Miller JA, DeLancey JO. Functional anatomy of the female pelvic floor. Ann N Y Acad Sci. 2007 Apr;1101:266-96. doi: 10.1196/annals.1389.034. Epub 2007 Apr 7.

Dietz HP, Clarke B, Herbison P. Bladder neck mobility and urethral closure pressure as predictors of genuine stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2002;13(5):289-93. doi: 10.1007/s001920200063.

Rud T, Andersson KE, Asmussen M, Hunting A, Ulmsten U. Factors maintaining the intraurethral pressure in women. Invest Urol. 1980 Jan;17(4):343-7.

DeLancey JO. Structural support of the urethra as it relates to stress urinary incontinence: the hammock hypothesis. Am J Obstet Gynecol. 1994 Jun;170(6):1713-20; discussion 1720-3. doi: 10.1016/s0002-9378(94)70346-9.

DeLancey JO, Trowbridge ER, Miller JM, Morgan DM, Guire K, Fenner DE, Weadock WJ, Ashton-Miller JA. Stress urinary incontinence: relative importance of urethral support and urethral closure pressure. J Urol. 2008 Jun;179(6):2286-90; discussion 2290. doi: 10.1016/j.juro.2008.01.098. Epub 2008 Apr 18.

Pontbriand-Drolet S, Tang A, Madill SJ, Tannenbaum C, Lemieux MC, Corcos J, Dumoulin C. Differences in pelvic floor morphology between continent, stress urinary incontinent, and mixed urinary incontinent elderly women: An MRI study. Neurourol Urodyn. 2016 Apr;35(4):515-21. doi: 10.1002/nau.22743. Epub 2015 Mar 1.

Madill SJ, Harvey MA, McLean L. Women with SUI demonstrate motor control differences during voluntary pelvic floor muscle contractions. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Apr;20(4):447-59. doi: 10.1007/s00192-008-0800-y. Epub 2009 Jan 23.

Smith MD, Coppieters MW, Hodges PW. Postural activity of the pelvic floor muscles is delayed during rapid arm movements in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Aug;18(8):901-11. doi: 10.1007/s00192-006-0259-7. Epub 2006 Dec 1.

Nygaard IE, Shaw JM. Physical activity and the pelvic floor. Am J Obstet Gynecol. 2016 Feb;214(2):164-171. doi: 10.1016/j.ajog.2015.08.067. Epub 2015 Sep 6.

Brandao S, Da Roza T, Mascarenhas T, Ramos I, Natal Jorge R. Do asymptomatic former high-impact sports practitioners maintain the ability to contract the pelvic floor muscles? J Sports Med Phys Fitness. 2015 Nov;55(11):1272-6. Epub 2014 Oct 30.

Varella LR, Torres VB, Angelo PH, Eugenia de Oliveira MC, Matias de Barros AC, Viana Ede S, Micussi MT. Influence of parity, type of delivery, and physical activity level on pelvic floor muscles in postmenopausal women. J Phys Ther Sci. 2016 Mar;28(3):824-30. doi: 10.1589/jpts.28.824. Epub 2016 Mar 31.

Bo K, Sherburn M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther. 2005 Mar;85(3):269-82.

Middlekauff ML, Egger MJ, Nygaard IE, Shaw JM. The impact of acute and chronic strenuous exercise on pelvic floor muscle strength and support in nulliparous healthy women. Am J Obstet Gynecol. 2016 Sep;215(3):316.e1-7. doi: 10.1016/j.ajog.2016.02.031. Epub 2016 Feb 17. Erratum In: Am J Obstet Gynecol. 2018 Nov;219(5):501.

Dumoulin C, Cacciari LP, Hay-Smith EJC. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005654. doi: 10.1002/14651858.CD005654.pub4.

Ziv E, Stanton SL, Abarbanel J. Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. Am J Obstet Gynecol. 2008 May;198(5):594.e1-7. doi: 10.1016/j.ajog.2008.01.061. Epub 2008 Apr 2.

Ziv E, Stanton SL, Abarbanel J. Significant improvement in the quality of life in women treated with a novel disposable intravaginal device for stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):651-8. doi: 10.1007/s00192-009-0824-y. Epub 2009 Mar 11.

Milne JL, Robert M, Tang S, Drummond N, Ross S. Goal achievement as a patient-generated outcome measure for stress urinary incontinence. Health Expect. 2009 Sep;12(3):288-300. doi: 10.1111/j.1369-7625.2009.00536.x.

Melin A, Tornberg AB, Skouby S, Faber J, Ritz C, Sjodin A, Sundgot-Borgen J. The LEAF questionnaire: a screening tool for the identification of female athletes at risk for the female athlete triad. Br J Sports Med. 2014 Apr;48(7):540-5. doi: 10.1136/bjsports-2013-093240. Epub 2014 Feb 21.

Hagstromer M, Oja P, Sjostrom M. The International Physical Activity Questionnaire (IPAQ): a study of concurrent and construct validity. Public Health Nutr. 2006 Sep;9(6):755-62. doi: 10.1079/phn2005898.

Bo K. Reproducibility of instruments designed to measure subjective evaluation of female stress urinary incontinence. Scand J Urol Nephrol. 1994 Mar;28(1):97-100. doi: 10.3109/00365599409180479.

Berube ME, Czyrnyj CS, McLean L. An automated intravaginal dynamometer: Reliability metrics and the impact of testing protocol on active and passive forces measured from the pelvic floor muscles. Neurourol Urodyn. 2018 Aug;37(6):1875-1888. doi: 10.1002/nau.23575. Epub 2018 Apr 10.

Thibault-Gagnon S, Gentilcore-Saulnier E, Auchincloss C, McLean L. Pelvic floor ultrasound imaging: are physiotherapists interchangeable in the assessment of levator hiatal biometry? Physiother Can. 2014 Fall;66(4):340-7. doi: 10.3138/ptc.2013-50.

Braekken IH, Majida M, Ellstrom-Engh M, Dietz HP, Umek W, Bo K. Test-retest and intra-observer repeatability of two-, three- and four-dimensional perineal ultrasound of pelvic floor muscle anatomy and function. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):227-35. doi: 10.1007/s00192-007-0408-7. Epub 2007 Jun 29.

Braekken IH, Majida M, Engh ME, Bo K. Test-retest reliability of pelvic floor muscle contraction measured by 4D ultrasound. Neurourol Urodyn. 2009;28(1):68-73. doi: 10.1002/nau.20618.

Burgio KL, Goode PS, Richter HE, Locher JL, Roth DL. Global ratings of patient satisfaction and perceptions of improvement with treatment for urinary incontinence: validation of three global patient ratings. Neurourol Urodyn. 2006;25(5):411-7. doi: 10.1002/nau.20243.