Recruiting

Intravaginal DevicesDo Intravaginal Devices Reduce Urinary Incontinence in Female Runners?

Sponsor:

University of Ottawa

Code:

NCT05773378

Conditions

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pessary Intervention

Tampon Intervention

Study Details

Brief summary:

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.

Conditions

Urinary Incontinence

Study ID

NCT05773378

Start date

Apr 14, 2023

Status verified date

Dec, 2024

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pessary Intervention

Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 10-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.

experimental: Tampon Intervention

Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

no intervention: Control Group

Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

Interventions

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.

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 measure

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 ]

Central Contacts and Locations

Central contacts

Linda McLean

613-562-5800 lmclea2@uottawa.ca

Sabine Vesting

613-562-5800 svesting@uottawa.ca

Locations

McLean Function Measurement Lab

Recruiting

Ottawa, Ontario, Canada, K1S 1S2

Contacts

Anne-Marie MacDonald, MSc

(613) 562-5800 mfmlab@uottawa.ca

Linda McLean, PhD

(613) 562-5800 lmclea2@uottawa.ca

More Information

Sponsor

University of Ottawa

Last update posted

Dec 17, 2024

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2024-12-17.