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NCT Number: NCT05773378

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pessary Intervention

Device

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.

Tampon Intervention

Device

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

Primary outcomes

  1. Urinary leakage tracking: Proportion of training sessions during which urine leakage occurred

    Time frame: at baseline, and during intervention week 10-12

    At baseline, participants will be asked to complete a bladder diary, recording leakage experiences during each running session over a two-week period, while running without any intervention. This tracking will be repeated for another two-week period starting in the eighth week of running with the intervention (weeks 10-12 of the protocol). Participants will receive daily reminders to fill it out.

  2. Patient's global impression of improvement

    Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

    Participants will be asked to rate their overall impression of symptom improvement over the 10-week intervention on a 7 step scale (7= very much worse, to 1= very much better). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their overall impression again at 16, 24 and 36 weeks.

  3. Patient's global satisfaction with treatment

    Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

    The participants will be asked how satisfied they were with their progress during the 10-weeks, on a scale from 0 to 100% (0 = not at all satisfied, 100 = completely satisfied). Also, a follow-up will be conducted upon finishing the intervention, and, if they are still using the intervention, participants will be invited to rate their satisfaction again at 16, 24 and 36 weeks.

  4. 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

    The ICIQ-FLUTS is a questionnaire for evaluating female lower urinary tract symptoms and impact on quality of life in research and clinical practice, with validity, reliability and responsiveness established with rigour in several data sets. It has a total of 12 questions; four questions on filling symptoms, three on voiding symptoms and five questions on urinary incontinence symptoms. The overall score ranges from 0-48, where all subscales scores are added. Higher scores indicate greater impact of individual symptoms for the patient.

    Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.

  5. 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

    The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a questionnaire that includes three questions about urinary incontinence frequency, severity, and impact on daily life, resulting in a score of 0-21. The fourth question aims to classify the type of urinary incontinence, for this study 'leaks when you are physically active/exercising.' The questionnaire has a Level A validation grade according to ICI standards, as its validity, reliability, and responsiveness have been tested in several data sets. Participants will be asked to complete it at baseline and after 12-weeks. Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks.

Secondary outcomes

  1. Intervention questionnaire

    Time frame: Post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

    A custom questionnaire with 20 questions was developed to collect information regarding participant's experience running with the intervention (tampon or pessary). The questions addresses the frequency of intervention use, ease of insertion and removal, comfort level while using the device, unintended effects (bleeding, vaginal discharge, pain), overall satisfaction, and the extent of urine leakage with the dispositive. Each question is rated on a scale form 0 to 100, with higher scores indicating a greater experience with the intervention. Participants randomized to the intervention groups will be asked to complete the questionnaire related to their assigned intervention after 12-weeks. Additionally, a follow-up will be conducted upon completing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 weeks later.

  2. Adherence to each intervention

    Time frame: Once a week during the 12 weeks of the study

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

  3. Unintended effects

    Time frame: Once a week during the 12 weeks of the study

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

  4. 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

    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 at baseline and post intervention (after 12-weeks). Also, a follow-up will be conducted upon finishing the intervention, and participants will be invited to complete the questionnaire again at 16, 24 and 36 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).

  5. Changes in bladder neck height

    Time frame: Baseline and post intervention (at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. Changes in bladder neck height will be assessed using ultrasound imaging at baseline and after 12 weeks. The images will be recorded before and after a 30-minute treadmill running protocol

  6. Changes in levator hiatus area

    Time frame: Baseline and post intervention (at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. 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.

  7. Changes in levator plate length

    Time frame: Baseline and post intervention ( at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. 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.

  8. Changes in pelvic floor muscle strength

    Time frame: Baseline and post intervention ( at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. 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.

  9. Changes in pelvic floor muscle stiffness

    Time frame: Baseline and post intervention ( at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. 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.

  10. Pad weight gain

    Time frame: Baseline and post intervention ( at 12 weeks)

    A subgroup of participants will be invited for an in-lab assessment of pelvic floor morphology before and after running. These 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda McLean

CONTACT

[email protected]

613-562-5800 ext. 4102

Sabine Vesting

CONTACT

[email protected]

613-562-5800 ext. 4102

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2023
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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