Pelvic floor anatomy and applied physiology.
Varuna Raizada, Ravinder K Mittal
https://pubmed.ncbi.nlm.nih.gov/18793993Actively Recruiting
Led by University of Ottawa · Updated on 2025-08-05
30
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether using a regular menstrual tampon or a Uresta pessary can reduce urine leakage caused by running-induced stress urinary incontinence in females aged 18 and older. The study also aims to see if these devices lessen changes in pelvic structure after running and whether participants continue using them during running over a 4-week period. The study is interventional and randomized, examining symptom reduction, satisfaction, and pelvic floor strain with these devices. Participants will attend three lab visits within 10 days, where bladder volume will be controlled and 3D ultrasound imaging of the pelvic area will be done before and after a treadmill running protocol. The protocol includes 25 minutes of moderate running followed by 5 minutes of higher intensity running. Participants will use either a tampon or the Uresta pessary during these runs, with urine leakage monitored every 5 minutes. After the study, participants may keep the pessary and will be contacted 4 weeks later to report device use and satisfaction. During the study, participants complete a baseline questionnaire on demographics and incontinence severity. Researchers will assess urine leakage severity at baseline and during visits 2 and 3, along with pelvic floor measurements before and after running. Follow-up at 4 weeks post-study will check continued device use. The study also tracks participant perceptions of improvement and measures changes in pelvic support structures. Safety and adherence are monitored throughout the trial.
CONDITIONS
Managing Impact-related Leakage During Exercise Using Intravaginal Support
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 10 days after screening
Participants use intravaginal devices such as a regular tampon and a bladder support pessary during running to assess their effectiveness in reducing urine leakage.
3 laboratory visits including baseline and two device visits
Duration - 4 weeks
Participants use the tampon or pessary during daily activities over a 4-week period following laboratory visits to assess continued device use.
1 follow-up visit approximately 4 weeks after last laboratory visit
Total: 1 location
1
University of Ottawa, Faculty of Health Sciences building, 200 Lees Avenue
Ottawa, Ontario, Canada, K1N 6N5
Actively Recruiting
G
Grace Collins, BSc.
A
Anne-Marie Lake, MSc.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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