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Intravaginal Devices for Urinary Incontinence

N/A
Recruiting
Led By Linda McLean
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Regularly (≥ 1 per week) experience urine leakage while running and report ≤1 urine leakage episode per month not associated with exercise
Cis-females aged 18 years and over who run at least 5 km in under 50 minutes at least twice per week for at least one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks; follow-up at 4, 12 and 24 weeks later.
Awards & highlights

Study Summary

This trial found that 1 in 5 women experience urine leakage while exercising. Exercise is important and it's recommended to look for alternatives to manage this condition to maintain physical and mental health.

Who is the study for?
This trial is for cis-female runners over 18 who can run 5 km in under 50 minutes at least twice a week and have experienced urine leakage while running regularly. They should not have urogenital surgery history, neurologic disorders, recent pregnancy, or conditions causing exercise-related risks.Check my eligibility
What is being tested?
The study tests if intravaginal devices like tampons or pessaries can help reduce urinary incontinence during running. It aims to find non-surgical ways to manage this condition that often leads women to limit their physical activities.See study design
What are the potential side effects?
Potential side effects of using intravaginal devices may include discomfort, increased risk of vaginal infections, and possible irritation. However, these will vary based on individual tolerance and proper use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I often leak urine when running but rarely at other times.
Select...
I am a woman over 18 who runs 5 km in under 50 minutes, twice a week for a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks; follow-up at 4, 12 and 24 weeks later.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks; follow-up at 4, 12 and 24 weeks later. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Intervention questionnaire
+3 more
Secondary outcome measures
Adherence to each intervention
Adverse events
Changes in bladder neck height
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tampon InterventionExperimental Treatment1 Intervention
Participants randomized to this group will receive 60 regular Tampax tampons and will be instructed to use them each time they run over a 12-week period. The tampon should be used only while running and removed and discarded when the training is over.
Group II: Pessary InterventionExperimental Treatment1 Intervention
Participants randomized to this group will receive an Uresta Incontinence Pessary to use each time they run over a 12-week period. They will be instructed to use the pessary only while running and remove it and wash it with soap and water when the training is over. Uresta is a reusable and removable device made of hypoallergenic medical-grade resin that is inserted into the vagina to provide mechanical support. It comes with a starter kit with 3 different sizes which work for over 80% of women. Participants will be instructed on how to test the 3 sizes to find out which one is right for them.
Group III: Control GroupActive Control1 Intervention
Participants randomized to this group won't receive any intervention and will be asked to continue their running training as usual for 12-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. After 12-weeks, they will be reassessed and will be offered the opportunity to receive a pessary if they desire so.

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor
204 Previous Clinical Trials
265,821 Total Patients Enrolled
Linda McLeanPrincipal InvestigatorUniversity of Ottawa
2 Previous Clinical Trials
113 Total Patients Enrolled

Media Library

Pessary Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05773378 — N/A
Urinary Incontinence Research Study Groups: Pessary Intervention, Control Group, Tampon Intervention
Urinary Incontinence Clinical Trial 2023: Pessary Intervention Highlights & Side Effects. Trial Name: NCT05773378 — N/A
Pessary Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05773378 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are interested participants still eligible to join this trial?

"Data found on clinicaltrials.gov indicates this trial is not actively recruiting patients right now, as it was first posted on March 21st 2023 and last edited on March 6th 2023. However, 151 alternative studies have open recruitment periods currently."

Answered by AI

What are the projected outcomes of this clinical experiment?

"The purpose of this 12-week clinical trial is to investigate weight gain, with secondary objectives being to observe any potential adverse events through weekly e-mail contact and follow up telephone calls. Ultrasound imaging will also be employed before and after a 30 minute running protocol on a treadmill in order to measure changes in bladder neck height and levator hiatus area."

Answered by AI
~43 spots leftby Feb 2025