Managing Impact-related Leakage During Exercise Using Intravaginal Support

Official title

Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?

Overview

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.

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.

Interventions

• Device 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
• Device 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.

Primary outcome measures

• Urine leakage severity [Time frame: At Baseline (Visit 1), and at Visit 2 and Visit 3, which will occur within 10 days of Baseline.]

Secondary outcome measures (5)

• Participant's perception of improvement [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: At 4-week follow-up (4 weeks after Visit 3, approximately Day 38 post-Baseline).]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue — Ottawa

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. PMID 18793993
• 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. PMID 39043585
• 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. PMID 27438055
• 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. PMID 28675537
• 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. PMID 17466709
• 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. PMID 33416968
• 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. PMID 33971737
• 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. PMID 37991566

Identifiers

NCT: NCT07103161 · H-06-22-8153

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗