Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID07103161

Does a Regular Tampon or Intravaginal Pessary Reduce Urine Leakage While Running in Females with Exercise-induced Urinary Incontinence?

Led by University of Ottawa · Updated on 2025-08-05

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Managing Impact-related Leakage During Exercise Using Intravaginal Support

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Participate in any exercise or sport involving running or brisk walking
  • Experience urine leakage during running or brisk walking
  • Speak and read English or French
Not Eligible

You will not qualify if you...

  • No urine leakage during the initial laboratory assessment
  • Currently pregnant or pregnant within the previous 6 months
  • History of cardiac, pulmonary, metabolic, or neurological conditions
  • History of incontinence surgery
  • History of hysterectomy
  • Symptoms only consistent with urgency incontinence
  • Experience pain with tampon use or during gynecologic exams

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

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

Ottawa, Ontario, Canada, K1N 6N5

Actively Recruiting

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Research Team

G

Grace Collins, BSc.

A

Anne-Marie Lake, MSc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Conservative interventions for female exercise-induced urinary incontinence: a systematic review.

Marina Petter Rodrigues, Marie-Ève Bérubé, Marylène Charette...

https://pubmed.ncbi.nlm.nih.gov/39043585

Evaluation of pelvic floor kinematics in continent and incontinent women during running: An exploratory study.

Monika Leitner, Helene Moser, Patric Eichelberger...

https://pubmed.ncbi.nlm.nih.gov/28675537

Effect of Pelvic Floor Symptoms on Women's Participation in Exercise: A Mixed-Methods Systematic Review With Meta-analysis.

Jodie G Dakic, Jean Hay-Smith, Jill Cook...

https://pubmed.ncbi.nlm.nih.gov/33971737

The acute effects of running on pelvic floor morphology and function in runners with and without running-induced stress urinary incontinence.

Marie-Ève Bérubé, Linda McLean

https://pubmed.ncbi.nlm.nih.gov/37991566

Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies.

Ceyhan Ceran Serdar, Murat Cihan, Doğan Yücel...

https://pubmed.ncbi.nlm.nih.gov/33380887