Intravaginal Support for Stress Incontinence

(MILES Trial)

Overseen By Grace Collins, BSc.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Pregnancy, Cardiac, Pulmonary, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a tampon or a Uresta pessary (a bladder support device) can reduce urine leakage during running, a common issue for many women. Researchers aim to determine if these interventions also lessen strain on the pelvic floor, which affects bladder support. They will assess whether participants continue using these products during runs over four weeks after the initial testing. Women who experience urine leakage while running or brisk walking might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance the quality of life for women facing similar issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these interventions are safe for reducing stress urinary incontinence during running?

Previous studies have used the Sportex regular tampon to help manage stress urinary incontinence (SUI) during activities like exercise. These studies reported no major safety concerns or negative effects, suggesting the tampon is generally well-tolerated.

Research has shown that the Uresta bladder support device is also safe and well-tolerated. In one study, 90% of users continued using it after 12 months, with no negative effects reported. Another study found that the device improved incontinence in 83% of users, with no significant safety issues.

Both the tampon and the Uresta device appear to be safe options for managing stress incontinence during running, as they have been tested in other studies without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intravaginal devices being tested for stress incontinence because they offer a non-surgical, convenient option for women. The Sportex regular tampon is being explored for its potential dual use, providing menstrual protection while also offering support to reduce urine leakage during activities. On the other hand, the Uresta bladder support device is designed specifically to provide customized support to the bladder neck, tackling stress incontinence more directly. These options could provide women with more control and comfort compared to traditional treatments like pelvic floor exercises or surgery.

What evidence suggests that these interventions might be effective for stress incontinence?

This trial will compare the effectiveness of a regular tampon and the Uresta bladder support device in managing stress urinary incontinence (SUI) during exercise. Research has shown that using a regular tampon can reduce SUI, with some women experiencing up to a 70% reduction in leakage while exercising. However, some women still felt the need for additional support, such as a pessary. The Uresta pessary has significantly reduced urinary incontinence and is easy to use. In one study, 73% of women indicated they would use Uresta again. Both tampons and pessaries offer promising results for managing exercise-related SUI, with the pessary possibly providing greater satisfaction and likelihood of continued use. ^{1 2 6 7 8}

Who Is on the Research Team?

Linda McLean, PhD.

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

This trial is for females aged 18 and older who experience urine leakage when running, known as running-induced stress urinary incontinence (RI-SUI). Participants should be able to complete a treadmill protocol and attend three lab visits. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

Speak and read English or French

Participate in any exercise or sport modality involving running or brisk walking

I experience urine leakage when I run or walk briskly.

Exclusion Criteria

Currently pregnant or have been pregnant in the previous 6 months

I have or had heart, lung, metabolic, or nerve conditions.

I only experience sudden urges to urinate that I cannot control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline and Laboratory Visits

Participants complete a baseline questionnaire and attend three laboratory visits within a 10-day period for ultrasound imaging and treadmill running tests.

10 days

3 visits (in-person)

Post-Lab Follow-up

Participants are contacted 4 weeks after the final visit to evaluate continued use of tampon or pessary and satisfaction with the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sportex regular tampon
• Uresta bladder support device

Trial Overview The study tests if using a Uresta pessary or regular tampon reduces symptoms of RI-SUI during exercise. It also examines changes in pelvic morphology after running and whether participants prefer the pessary over the tampon for continued use post-study.

How Is the Trial Designed?

Group I: Tampon Visit: run with tampon Active Control 1 Intervention

Group II: Pessary Visit: run with pessary Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07103161

Managing Impact-related Leakage During Exercise Using ... Participants will use a regular absorbency Sportex tampon as a conservative intravaginal support to potentially reduce stress urinary incontinence (SUI) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12053262/

Intravaginal devices for running‐induced urinary ... For example, a patient with a 70% reduction in leakage may feel only 50% satisfied if they still need a pessary or tampon while running.

3. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.16474

Conservative interventions for female exercise‐induced ... When comparing pessary, tampon, and no intervention, two repeated-measures studies found tampons may reduce leakage more than pessaries in ...

4. researchgate.net researchgate.net/publication/382492841_Conservative_interventions_for_female_exercise-induced_urinary_incontinence_a_systematic_review

Conservative interventions for female exercise‐induced ... When comparing pessary, tampon, and no intervention, two repeated‐measures studies found tampons may reduce leakage more than pessaries in CrossFit exercisers ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39883126/

Efficacy and Tolerance of the Tampsec Vaginal Tampon for ... On the basis of PGI-I responses, the treatment was successful in 60.9% of women in the tampon group and 17.4% of controls (p = 0.003). The ...

6. researchgate.net researchgate.net/publication/323733276_Effects_of_vaginal_tampon_training_added_to_pelvic_floor_muscle_training_in_women_with_stress_urinary_incontinence_randomized_controlled_trial

Effects of vaginal tampon training added to pelvic floor ... The primary outcome measure was self-reported improvement, while secondary outcome measures were severity of incontinence, quality of life (QoL), urinary ...

7. scholars.unh.edu scholars.unh.edu/cgi/viewcontent.cgi?article=1634&context=honors

Quality of Life and Symptom Sharing Among Women with ... Stress urinary incontinence. (SUI) is a “complaint of involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7720247/

Safety and Efficacy of a Disposable Vaginal Device for ... The aim of this study was to evaluate the efficacy and safety of an over-the-counter device for the treatment of stress urinary incontinence (SUI) in females.