What side effects are associated with this type of intervention?

Pelvic Floor Muscle Training (PFMT) is a common treatment for urinary incontinence that involves exercises to strengthen the pelvic floor muscles, thereby improving bladder control. The side effects of PFMT are generally minimal but can include temporary muscle soreness or discomfort. Other common treatments for urinary incontinence include medications such as anticholinergics, which can cause dry mouth, constipation, and blurred vision, and beta-3 agonists, which may lead to increased blood pressure and headache. Surgical options, though less common, can have more significant risks such as infection, bleeding, and pain.

What prior FDA approvals exist?

Pelvic Floor Muscle Training (PFMT) is a well-supported, non-pharmacological treatment for urinary incontinence (UI) that focuses on strengthening the pelvic floor muscles to improve bladder control. While specific FDA-approved drugs directly related to PFMT are not mentioned, there is Grade A evidence supporting the effectiveness of PFMT in reducing UI symptoms. Additionally, intravaginal pessaries have shown some evidence of reducing UI symptoms in the general female population. These conservative interventions are key alternatives to pharmacological treatments for managing UI.

What other types of research exist?

Promising alternatives to Pelvic Floor Muscle Training for Urinary Incontinence patients include the use of intravaginal pessaries and behavioral interventions. These methods have shown some evidence of reducing UI symptoms and may be considered as part of a comprehensive treatment plan.

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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

Be older than 18 years old

Must not have

Have a known neurologic disorder (e.g. stroke, multiple sclerosis)

Dyspareunia to the extent that they cannot undergo a regular gynaecologic examination

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help women who leak urine while running by using exercises and small devices to support their bladder. The exercises strengthen muscles, and the devices provide physical support to prevent leakage.

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.

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.

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

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I often leak urine when running but rarely at other times.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a diagnosed neurological condition like stroke or MS.

Select...

I experience severe pain during sexual intercourse, preventing me from undergoing a regular gynecological exam.

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I am experiencing pain or have a muscle or bone injury currently.

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I experience symptoms related to the female athlete triad.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention at 12 weeks, with follow-ups at 16, 24, and 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)

International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

Patient's global impression of improvement

+2 more

Secondary study objectives

Adherence to each intervention

Brisk walking and Running lower Urinary Tract Symptoms Questionnaire (BRUTS) score

Changes in bladder neck height

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 10-week period. The tampon should be used only while running and removed and discarded when the training is over. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

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 10-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 10-weeks. They will also be instructed to not begin any treatment for urinary incontinence until their reassessment. Four weeks after the intervention (at the 16 weeks follow-up), they will receive a pessary with instruction how to use it if they desire so.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pelvic Floor Muscle Training (PFMT) is a common treatment for Urinary Incontinence (UI) that works by strengthening the pelvic floor muscles, which support the bladder and urethra. Enhanced muscle strength and endurance improve bladder control, reducing incontinence episodes. This matters for UI patients as it offers a non-invasive, low-risk method to manage symptoms, improve quality of life, and encourage continued physical activity, which is often limited by incontinence.