Managing Impact-related Leakage During Exercise Using Intravaginal Support
NCT ID: NCT07103161
Last Updated: 2025-08-05
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-09-13
2026-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Tampon Visit: run with tampon
Sportex regular 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.
Pessary Visit: run with pessary
Uresta bladder support device
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.
Interventions
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Uresta bladder support device
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University of Ottawa
OTHER
Responsible Party
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Dr. Linda McLean
Full Professor
Principal Investigators
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Linda McLean, PhD.
Role: PRINCIPAL_INVESTIGATOR
University of Ottawa
Locations
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University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Petter 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.
Lovatsis 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.
Leitner 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.
Farrell 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.
Falah-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.
Dakic 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.
Berube 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.
Waetjen 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.
Serdar 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.
Shaw 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.
Rzymski 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.
Nygaard 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.
Nekkanti 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.
Imamura 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.
Goldstick O, Constantini N. Urinary incontinence in physically active women and female athletes. Br J Sports Med. 2014 Feb;48(4):296-8. doi: 10.1136/bjsports-2012-091880. Epub 2013 May 18.
Duenas-Garcia OF, Shapiro RE, Gaccione P. Safety and Efficacy of a Disposable Vaginal Device for Stress Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2021 Jun 1;27(6):360-364. doi: 10.1097/SPV.0000000000000861.
Chisholm L, Delpe S, Priest T, Reynolds WS. Physical Activity and Stress Incontinence in Women. Curr Bladder Dysfunct Rep. 2019 Sep;14(3):174-179. doi: 10.1007/s11884-019-00519-6. Epub 2019 Jul 1.
Brown WJ, Miller YD. Too wet to exercise? Leaking urine as a barrier to physical activity in women. J Sci Med Sport. 2001 Dec;4(4):373-8. doi: 10.1016/s1440-2440(01)80046-3.
Brennand E, Ruiz-Mirazo E, Tang S, Kim-Fine S; Calgary Women's Pelvic Health Research Group. Urinary leakage during exercise: problematic activities, adaptive behaviors, and interest in treatment for physically active Canadian women. Int Urogynecol J. 2018 Apr;29(4):497-503. doi: 10.1007/s00192-017-3409-1. Epub 2017 Jul 6.
Bo K. Urinary incontinence, pelvic floor dysfunction, exercise and sport. Sports Med. 2004;34(7):451-64. doi: 10.2165/00007256-200434070-00004.
Al-Shaikh G, Syed S, Osman S, Bogis A, Al-Badr A. Pessary use in stress urinary incontinence: a review of advantages, complications, patient satisfaction, and quality of life. Int J Womens Health. 2018 Apr 17;10:195-201. doi: 10.2147/IJWH.S152616. eCollection 2018.
Other Identifiers
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H-06-22-8153
Identifier Type: -
Identifier Source: org_study_id
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