NCT Number: NCT07103161
The goal of this study is to evaluate the effectiveness of using a regular menstrual tampon or a Uresta pessary to reduce urine leakage associated with running-induced stress urinary incontinence (RI-SUI) in females aged 18 and older. Secondly, the study aims to assess whether either intervention mitigates transient changes in pelvic morphology that occur following a single running bout. Lastly, we aim to evaluate whether participants continue using either intervention during running over the 4-week period following their in-lab participation. The hypotheses are:
Hypothesis 1: Among females with RI-SUI, both a tampon and pessary used during a single running bout will reduce urinary leakage symptoms, with greater symptom reduction observed when using the pessary.
Hypothesis 2: Participants will report high satisfaction and perceived symptom improvement with both the tampon and pessary, with higher satisfaction and greater improvement reported for the pessary.
Hypothesis 3: Both the tampon and pessary will reduce pelvic floor strain incurred by the end of the run, as evidenced by less bladder neck descent, levator plate lengthening, and levator hiatus area increasing relative to that observed when no tampon or pessary is used.
Hypothesis 4: A greater proportion of participants will report continued use of the pessary compared to the tampon over the 4-week post-lab period, with higher frequency of use and fewer reported discontinuations.
We will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support.
Participants will complete a baseline questionnaire to collect demographic information and assess incontinence severity. They will then attend three laboratory visits within a 10-day period. At each visit, bladder volume will be standardized to between 100 and 200mL, then the participant will undergo three-dimensional (3D) transperineal ultrasound imaging conducted in a standing position. Following imaging, participants will complete a treadmill protocol consisting of 25-minutes running at a moderately difficult pace (rated at 13 - 14 on the Borg Perceiver Rate of Exertion scale), followed by 5 minutes of running at a higher intensity pace. During the run, participants will be asked at 5 minute intervals whether they experienced any urine leakage and to report their perceived amount of leakage. The ultrasound image protocol will be repeated immediately after the run.
Participants will be allowed to keep the pessary and will be contacted 4-weeks after the final visit to evaluate whether or not they continued use of a tampon or the pessary, and, if so, we will ask them to report their satisfaction with the intervention(s) they used.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Ottawa, Ontario, K1N 6N5, Canada
Location status: Recruiting
Anne-Marie Lake, MSc.
CONTACT
613-562-5800 ext. 4102
Grace Collins, BSc.
CONTACT
613-562-5800 ext. 4102
Linda McLean, PhD.
PRINCIPAL_INVESTIGATOR
More than 30% of females experience urinary incontinence (UI) during exercise. For many women, urine leakage during exercise can become a barrier to staying active, leading them to modify their exercise routine or avoid triggering activities altogether. Beyond the physical inconvenience, urinary incontinence can affect self-esteem, social participation, and mental health. Helping women stay active without embarrassment or fear of leakage has both physical and psychological benefits.
The pelvic floor muscles (PFMs) and associated connective tissues play a critical role in continence control. These structures support the pelvic organs and help maintain their positioning such that the urethra is optimally compressed during increases in intra-abdominal pressure. Dysfunction of the PFMs and connective tissues will cause the bladder to descend during weight-bearing activities, and the urethra, no longer in its optimal position, may remain open - resulting in urine leakage. This form of UI, known as stress urinary incontinence (SUI), is commonly experienced as urine leakage during tasks such as coughing, laughing, and physical activity. High-impact movements like running, jumping, and inclined walking are known to increase the loads experienced by the pelvic floor, making SUI especially common during these types of activities.
Intravaginal products such as tampons and pessaries (reusable medical devices placed in the vagina) are recommended to help manage UI during everyday activities such as coughing and sneezing. However, their effectiveness during physical activities - such as running or brisk walking - remains unclear. This study aims to determine whether a standard menstrual tampon and/or a bladder support (Uresta) pessary can reduce urine leakage during running and/or brisk walking in active females. A secondary objective is to assess whether these devices mitigate the descent of the bladder that we have observed in females after running or brisk walking. Lastly, we aim to assess continued device use over a 4-week period following all laboratory visits.
By evaluating the effectiveness of accessible, non-invasive devices, this research may offer immediate, low-barrier strategies to help active women self-manage urinary incontinence - empowering them to maintain their physical activity routines and support their long-term health.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Uresta bladder support device is an intravaginal device indicated for adult women over 18 years of age who experience stress urinary incontinence, including urine leakage during exercise and non-exercise activities such as coughing and laughing. The device is FDA-cleared and licensed by Health Canada. Participants receive the entire kit that includes the three most common sizes which fit 90% of women. Two additional sizes are available in the lab if needed. Participants will be instructed to self-insert the Uresta prior to running, following the manufacturer instructions with researcher guidance as needed. The device aims to provide mechanical support to the urethra and bladder neck to prevent urine leakage during activities that provoke leakage.
Other names: Uresta pessary
Participants will use a regular absorbency Sportex tampon as a conservative intravaginal support to potentially reduce stress urinary incontinence (SUI) symptoms during running. Participants will be instructed to insert the tampon prior to running into the mid-to-upper vaginal canal while standing or sitting.
Other names: Menstrual tampon
Time frame: At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.
Self-reported urine leakage is evaluated as presence (yes/no) and amount (drops, squirts, gush) every 5 minutes during a 38-minute treadmill run. Leakage severity index is calculated as the proportion of 5-minute blocks with leakage times the median leakage amount per block.
Time frame: At Visit 2 and Visit 3 only, which will occur within 10 days of Baseline (Visit 1).
Participants report perception of improvement with each device on a scale of 0% (not improved) to 100% (very much improved).
Time frame: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Levator plate length will be assessed before and after running under each condition. The primary outcome is the change in levator plate length, calculated as the difference between pre- and post-run measurements. Levator plate length is measured using 2D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the straight-line distance between the anorectal junction and the pubic symphysis.
Time frame: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Bladder neck height will be assessed before and after running under each condition. The primary outcome is the change in bladder neck height, calculated as the difference between per- and post-run measurements. Bladder neck height is measured using 2D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the perpendicular distance from the pubic symphyseal line to the bladder neck.
Time frame: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Levator hiatus area will be assessed before and after running under each condition. The primary outcome is the change in levator hiatus area, calculated as the difference between pre- and post-run measurements. Levator hiatus area is measured using 3D transperineal ultrasound imaging of the pelvic structures, acquired with participants in the standing position. The measurement is defined as the hypoechoic region visualized in the transverse plane.
Time frame: At 4-week follow-up (4 weeks after Visit 3, approximately Day 38 post-Baseline).
Participants complete an online questionnaire that evaluates their use of either the tampon or pessary intervention during running over a 4-week period after completing the in-lab component of the study. They are asked whether they used the tampon or pessary while running (Yes/No) and to rate the frequency of usage on a scale of 0 (not used) to 100 (used during every run). If they did not use the pessary/tampon at all or if they stopped using the pessary/tampon during the 4-week period, they are asked to share the number of runs they ran with the device and their reasons for stopping its usage.
Contact information is provided by the study sponsor or research team.
Anne-Marie Lake, MSc.
CONTACT
613-562-5800 ext. 4102
Grace Collins, BSc.
CONTACT
613-562-5800 ext. 4102
University of Ottawa
Other
Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?
Acronym: MILES
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