Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Official title

Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners?

Overview

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.

Detailed description

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.

Interventions

• Device Pessary Intervention
  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 10-week period.
• Device Tampon Intervention
  Participants will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period.

Primary outcome measures

• Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred [Time frame: at baseline, and during intervention week 10-12]
• Patient's global impression of improvement [Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]
• Patient's global satisfaction with treatment [Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]
• International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) [Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]
• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) [Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]

Secondary outcome measures (10)

• Intervention questionnaire [Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]
• Adherence to each intervention [Time frame: Once a week during the 12 weeks of the study]
• Unintended effects [Time frame: Once a week during the 12 weeks of the study]
• Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score [Time frame: Baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks]
• Changes in bladder neck height [Time frame: Baseline and post intervention (at 12 weeks)]
• Changes in levator hiatus area [Time frame: Baseline and post intervention (at 12 weeks)]
• Changes in levator plate length [Time frame: Baseline and post intervention ( at 12 weeks)]
• Changes in pelvic floor muscle strength [Time frame: Baseline and post intervention ( at 12 weeks)]
• Changes in pelvic floor muscle stiffness [Time frame: Baseline and post intervention ( at 12 weeks)]
• Pad weight gain [Time frame: Baseline and post intervention ( at 12 weeks)]

Eligibility criteria

Inclusion criteria

• Females aged 18 years and over who run at least twice a week for a minimum of 10K/week (minimum speed of 6 km/h to ensure high impact), who have done so for at least 6 months (to ensure adequate duration of exposure), and who commit to continue the same amount during the study period
• Who regularly (≥ 1 per week) experience urine leakage while running.

Exclusion criteria

• Any risk factors related to exercise;
• Pain or musculoskeletal injury at the time of the screening;
• History of urogenital surgery;
• Symptoms of the female athlete triad;
• Have a known neurologic disorder (e.g. stroke, multiple sclerosis);
• Pregnancy or partum within the previous year;

For the in-lab assessment:

• Ability to run with a moderately full bladder for 38 minutes on a treadmill
• BMI ≥ 30
• Pelvic organ prolapse ≥ 2

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• McLean Function Measurement Lab — Ottawa

Publications

• 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. PMID 17908260
• 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. PMID 29169586
• 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. PMID 20686977
• 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. PMID 23648225
• 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. PMID 16055580
• 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. PMID 2923841
• 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. PMID 17611834
• Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004. PMID 15233598

Identifiers

NCT: NCT05773378 · H-06-22-8219

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗