Vaginal tampon or pessary to reduce leakage during running
Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?
This will test whether using a regular tampon or a Uresta pessary reduces urine leakage for women 18 and older who leak while running or brisk walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Ottawa Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07103161 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study enrolls women aged 18 and older who experience urine leakage during running or brisk walking. Participants complete in-lab runs with no device, with a regular menstrual tampon, and with a Uresta pessary while urine leakage and transient pelvic floor morphology changes are measured before and after each bout. The study compares leakage amounts and pelvic position changes across the three conditions and collects participant-reported satisfaction and device use over the following four weeks. Investigators expect both devices to reduce running-induced leakage, with greater symptom reduction and satisfaction for the pessary.
Who should consider this trial
Good fit: Women over 18 who experience urine leakage during running or brisk walking, can read English or French, are not currently pregnant or recently postpartum, and do not have exclusionary surgical or medical histories are ideal candidates.
Not a fit: People with urgency-only incontinence, prior incontinence surgery or hysterectomy, inability to tolerate tampon use, recent pregnancy within six months, or major cardiac/pulmonary/metabolic/neurologic conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, these intravaginal devices could allow women to run with less urine leakage and help them stay active with greater confidence.
How similar studies have performed: Intravaginal pessaries and tampons are used clinically to manage activity-related leakage and have supporting evidence, but rigorous trials specifically targeting running-induced leakage are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years of age * Participate in any exercise or sport modality involving running or brisk walking * Experiences urine leakage during running or brisk walking * Speak and read English or French Exclusion Criteria: * No urine leakage in the first laboratory assessment (baseline / no intervention) * Currently pregnant or have been pregnant in the previous 6 months * Had or have had cardiac, pulmonary, metabolic and/or neurological conditions * History of incontinence surgery * Hysterectomy * Symptoms consistent with urgency incontinence only * Experience pain with tampon use or during gynecologic examinations
Where this trial is running
Ottawa, Ontario
- University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Linda McLean, PhD. — University of Ottawa
- Study coordinator: Grace Collins, BSc.
- Email: gcollins@uottawa.ca
- Phone: 613-562-5800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.