Stress Urinary Incontinence (SUI)MILESNCT07103161
Managing Impact-related Leakage During Exercise Using Intravaginal Support
A study testing Uresta bladder support device and Sportex regular tampon in people with Stress Urinary Incontinence (SUI), run by University of Ottawa at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Uresta bladder support device and Sportex regular tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2022to Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue
Ottawa, Ontario, K1N 6N5
Grace Collins, BSc., 613-562-5800 ext. 4102, gcollins@uottawa.ca
Anne-Marie Lake, MSc., 613-562-5800 ext. 4102, alake@uottawa.ca
About this study
Official title: Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Uresta bladder support device, Sportex regular tampon
- Keywords
- stress urinary incontinence, conservative treatment, pelvic floor strain, pessary, bladder support device, urinary symptoms, tampon, urine leakage, urine leakage with exercise, urine leakage with running
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uresta bladder support deviceDevice
Also called Uresta pessary
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.
Sportex regular tamponDevice
Also called Menstrual tampon
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.
| Study group | Role | What they receive |
|---|---|---|
| Tampon Visit: run with tampon | Active comparator | Not described Receives: Device: Sportex regular tampon |
| Pessary Visit: run with pessary | Active comparator | Not described Receives: Device: Uresta bladder support device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine leakage severity
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.
Measured: At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.
Secondary outcomes (5)
Participant's perception of improvement
Participants report perception of improvement with each device on a scale of 0% (not improved) to 100% (very much improved).
Measured: At Visit 2 and Visit 3 only, which will occur within 10 days of Baseline (Visit 1).
Change in levator plate length observed after an acute running bout
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.
Measured: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Change in bladder neck height observed after an acute running bout
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.
Measured: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Change in levator hiatus area observed after an acute running bout
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.
Measured: At Baseline (Visit 1), Visit 2, and Visit 3 - each with pre- and post-running assessments, within 10 days of Baseline.
Use of tampon or pessary throughout the 4-week post-lab period
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.
Measured: At 4-week follow-up (4 weeks after Visit 3, approximately Day 38 post-Baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start13 Sep 2022
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is an assessor blind randomized crossover study design in which all participants complete a baseline visit and are then repeat the protocol at two subsequent visits, one with the tampon and one with the pessary, with the order randomized.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Linda McLean, University of Ottawa
- Investigators
- Linda McLean, PhD., Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103161
- Sponsor's protocol ID
- H-06-22-8153
- Acronym
- MILES
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared to investigators who contact the researchers and request access.
Publications
Raizada V, Mittal RK. Pelvic floor anatomy and applied physiology. Gastroenterol Clin North Am. 2008 Sep;37(3):493-509, vii. doi: 10.1016/j.gtc.2008.06.003.
PubMed 18793993Petter Rodrigues M, Berube ME, Charette M, McLean L. Conservative interventions for female exercise-induced urinary incontinence: a systematic review. BJU Int. 2024 Dec;134(6):906-917. doi: 10.1111/bju.16474. Epub 2024 Jul 23.
PubMed 39043585Lovatsis D, Best C, Diamond P. Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.
PubMed 27438055Leitner M, Moser H, Eichelberger P, Kuhn A, Baeyens JP, Radlinger L. Evaluation of pelvic floor kinematics in continent and incontinent women during running: An exploratory study. Neurourol Urodyn. 2018 Feb;37(2):609-618. doi: 10.1002/nau.23340. Epub 2017 Jul 4.
PubMed 28675537Farrell SA, Baydock S, Amir B, Fanning C. Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8. doi: 10.1016/j.ajog.2006.11.038.
PubMed 17466709Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8.
PubMed 33416968Dakic JG, Hay-Smith J, Cook J, Lin KY, Calo M, Frawley H. Effect of Pelvic Floor Symptoms on Women's Participation in Exercise: A Mixed-Methods Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2021 Jul;51(7):345-361. doi: 10.2519/jospt.2021.10200. Epub 2021 May 10.
PubMed 33971737Berube ME, McLean L. The acute effects of running on pelvic floor morphology and function in runners with and without running-induced stress urinary incontinence. Int Urogynecol J. 2024 Jan;35(1):127-138. doi: 10.1007/s00192-023-05674-3. Epub 2023 Nov 22.
PubMed 37991566Waetjen LE, Subak LL, Shen H, Lin F, Wang TH, Vittinghoff E, Brown JS. Stress urinary incontinence surgery in the United States. Obstet Gynecol. 2003 Apr;101(4):671-6. doi: 10.1016/s0029-7844(02)03124-1.
PubMed 12681869Serdar CC, Cihan M, Yucel D, Serdar MA. Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies. Biochem Med (Zagreb). 2021 Feb 15;31(1):010502. doi: 10.11613/BM.2021.010502. Epub 2020 Dec 15.
PubMed 33380887Shaw JM, Hamad NM, Coleman TJ, Egger MJ, Hsu Y, Hitchcock R, Nygaard IE. Intra-abdominal pressures during activity in women using an intra-vaginal pressure transducer. J Sports Sci. 2014;32(12):1176-85. doi: 10.1080/02640414.2014.889845. Epub 2014 Feb 28.
PubMed 24575741Rzymski P, Burzynski B, Knapik M, Kociszewski J, Wilczak M. How to balance the treatment of stress urinary incontinence among female athletes? Arch Med Sci. 2020 Oct 21;17(2):314-322. doi: 10.5114/aoms.2020.100139. eCollection 2021.
PubMed 33747266Nygaard 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.
PubMed 16055580Nekkanti S, Wu JM, Hundley AF, Hudson C, Pandya LK, Dieter AA. A randomized trial comparing continence pessary to continence device (Poise Impressa(R)) for stress incontinence. Int Urogynecol J. 2022 Apr;33(4):861-868. doi: 10.1007/s00192-021-04967-9. Epub 2021 Sep 9.
PubMed 34505171Imamura M, Williams K, Wells M, McGrother C. Lifestyle interventions for the treatment of urinary incontinence in adults. Cochrane Database Syst Rev. 2015 Dec 2;2015(12):CD003505. doi: 10.1002/14651858.CD003505.pub5.
PubMed 26630349