Intravaginal Devices for Urinary Incontinence

Overseen By Sabine Vesting

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Ottawa

Disqualifiers: Pain, Urogenital surgery, Neurologic disorder, others

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

Compensation: Varies

Number of Visits: 18

Duration: 10 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how different intravaginal devices can reduce urine leakage in females who experience this issue while running. The study compares a pessary (a reusable device providing internal support) and regular tampons during exercise to determine which better eases symptoms of urinary incontinence. Females who run at least twice a week and frequently experience urinary leakage while running are ideal candidates for this study. Participants will use a pessary, a tampon, or no intervention while maintaining their running routine for 10 weeks. As an unphased trial, this study allows participants to contribute to research that could enhance the quality of life for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these intravaginal devices are safe for managing urinary incontinence during running?

Research shows that both pessaries and tampons are generally safe to use. Studies indicate that pessaries do not pose significant risks and might even be safer than other treatments for stress urinary incontinence. Some research also suggests that pessaries are safe during pregnancy and have been used for various conditions without major problems.

Safety assessments confirm that tampons can be used safely. As over-the-counter products, they are widely available and regulated for safety. Past studies comparing tampons with other devices found that tampons can help reduce urine leakage during exercise.

In summary, both pessaries and tampons have been studied and are considered safe options. They help manage urinary incontinence and are low-risk for most users. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for urinary incontinence because they offer simple, non-surgical solutions that can be used specifically during physical activities like running. The pessary intervention stands out because it uses a reusable, hypoallergenic medical-grade resin device that provides mechanical support when inserted into the vagina. This makes it environmentally friendly and cost-effective compared to single-use products. On the other hand, the tampon intervention is a familiar and easily accessible option for many, used specifically to provide support during runs. Both options focus on convenience and flexibility, allowing women to manage incontinence on their own terms.

What evidence suggests that these intravaginal devices are effective for urinary incontinence?

This trial will compare the effectiveness of two intravaginal devices for managing urinary incontinence during exercise. Participants in one arm will use a pessary, which research shows is a promising option for treating stress urinary incontinence (SUI). Studies have found that 89% to 92% of women can be successfully fitted with pessaries, and many remain satisfied with their use over time. Pessaries provide support to reduce leakage during physical activities.

In another arm, participants will use tampons, which research has discovered can greatly reduce leakage and improve symptoms during exercise. In some studies, nearly 70% of users noticed a significant reduction in urine leakage compared to those who did not use them. Both pessaries and these special tampons offer practical ways to manage urine leakage during exercise. ^{3 6 7 8 9}

Who Is on the Research Team?

Linda McLean

Principal Investigator

University of Ottawa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am a woman over 18 who runs 5 km in under 50 minutes, twice a week for a year.

Exclusion Criteria

You have been pregnant or given birth in the past year.

I have a diagnosed neurological condition like stroke or MS.

I have had surgery on my urinary or genital organs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including bladder diary and questionnaires

2 weeks

1 visit (in-person)

Treatment

Participants use assigned intervention (pessary or tampon) during running for 10 weeks

10 weeks

Weekly check-ins (virtual)

Post-intervention Assessment

Participants complete post-intervention assessments including bladder diary and questionnaires

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up assessments at 16, 24, and 36 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pessary Intervention
• Tampon Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Tampon Intervention Experimental Treatment 1 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 Intervention Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Recruited

267,000+

Published Research Related to This Trial

In a study involving 60 women with severe stress urinary incontinence, 85% achieved a significant reduction of 70% or more in pad weight gain after using a novel intravaginal device for 28 days, indicating its efficacy.

The device was found to be easy to use and well-tolerated, leading to improvements in quality of life and satisfaction among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. Ziv, E., Stanton, SL., Abarbanel, J.[2008]

In a study of 56 women aged 47 to 89 who used pessaries for an average of 4.5 years, the long-term use of pessaries effectively managed pelvic organ prolapse and urinary incontinence symptoms with lower complication rates than previously reported.

Despite the effectiveness of pessaries, 29% of participants experienced complications, and those considering surgery reported more bothersome symptoms, indicating that while pessaries are a viable long-term option, some women may still seek surgical solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in women who use pessaries for longer than 12 months. Tenfelde, S., Tell, D., Thomas, TN., et al.[2016]

A scoping review led to the development of the first competency standards for physiotherapists managing vaginal support pessaries, created by a panel of 29 experts through an e-Delphi process.

These standards, which cover essential knowledge and specific roles in pessary management, aim to enhance training and safety for women with pelvic organ prolapse, ensuring better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a multinational, multidisciplinary competency framework for physiotherapy training in pessary management: an E-Delphi study. Neumann, PB., Radi, N., Gerdis, TL., et al.[2022]

Pessaries are generally safe and effective for treating pelvic organ prolapse (POP), with serious complications being rare; the most common issues reported were vesicovaginal and rectovaginal fistulas, occurring in 25% and 19% of cases, respectively, among 36 articles reviewed.

The study suggests that patients with a good self-care index are ideal candidates for pessary use, and further research is needed to identify risk factors for serious complications, although this may be challenging due to the long follow-up required.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rare complications of pessary use: A systematic review of case reports. Dabic, S., Sze, C., Sansone, S., et al.[2022]

In a study of 75 women who self-managed their vaginal ring pessaries for at least two years, the overall rate of adverse events (AEs) was only 11.8%, significantly lower than the 43-56% reported for traditional clinic-managed protocols.

Among the participants, 52.9% continued using the pessary after a median follow-up of 50.5 months, indicating that self-management can be a safe and effective option for women with pelvic organ prolapse or stress incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does monthly self-management of vaginal ring pessaries reduce the rate of adverse events? A clinical audit. Moore, KH., Lammers, K., Allen, W., et al.[2022]

Pessaries are a low-risk and effective non-surgical treatment for pelvic organ prolapse, suitable for patients who either do not want surgery or need a diagnostic tool to assess surgical outcomes.

With proper training, most patients can be successfully fitted with a pessary and manage it themselves, leading to high patient satisfaction and effective symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pessary use and management for pelvic organ prolapse. Atnip, SD.[2009]

A new intravesical device was successfully tested in 35 patients with stress urinary incontinence, providing a novel treatment option that allows for voluntary bladder opening while blocking leaks.

This device addresses the limitations of existing treatments, as it does not create a communication between the bladder and vulva, thereby reducing the risk of urinary infections commonly associated with other surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approach to the management of stress urinary incontinence in patients with treatment failure. Yachia, D.[2016]

A silicone pessary, used to treat urinary incontinence, was found inside an 83-year-old patient after being retained for 10 years, leading to a serious complication known as urosepsis.

The case highlights the importance of regular monitoring and patient awareness regarding the use of pessaries, as neither the patient nor the healthcare provider detected its prolonged presence, which can result in significant health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rare case report - Urosepsis as a result of a neglected and forgotten pessary for 10 years. Maloku, H., Maloku, R.[2023]

Vaginal pessaries are generally safe and effective for treating pelvic organ prolapse, but neglecting their care can lead to complications, such as migration to the bladder or rectum.

In a rare case involving an elderly woman, a pessary caused mild discomfort and partial expulsion through the perineal skin, but it was easily treated by cutting and removing the pessary, highlighting the importance of regular follow-up for pessary users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaction after partial expulsion of a neglected pessary. Berger, J., Van den Bosch, T., Deprest, J.[2021]

In a study involving 33 patients with stress incontinence due to urethral sphincter dysfunction, a new silicone rubber inflatable vaginal pessary showed promising results, with 9 out of 20 patients reporting subjective improvement after one month of use.

Urodynamic assessments revealed significant increases in maximum urethral closure pressure and bladder neck elevation, indicating that the pessary effectively enhances urethral function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of female urinary incontinence device. Cardozo, LD., Stanton, SL.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5909791/

Pessary use in stress urinary incontinence: a review of ... Multicenter studies reported 89%–92% success rate for fitting pessaries in women with SUI. ... However, the population of women using a pessary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04590092

Pessary Use for Stress Urinary Incontinence in Pregnancy Up to 63% of non-pregnant women fitted with an incontinence pessary are satisfied with the treatment at 3 months; after one year of use 50-59% of women remain ...

3. mdpi.com mdpi.com/2227-9032/13/21/2659

Effectiveness of Vaginal Pessary Use in Improving Quality ... These findings demonstrate that pessary use provided multidimensional symptom relief across prolapse-related, urinary, and bowel domains. Table 4. Changes in ...

4. ajog.org ajog.org/article/S0002-9378%2806%2902410-0/fulltext

Effectiveness of a new self-positioning pessary for ... Among women successfully fitted at 2 weeks, 16 of 21 or 76% continued using their pessary at 1 year. There were no complications with pessary use. Conclusion.

5. ics.org ics.org/2021/abstract/141

User satisfaction study of a vaginal support pessary to ... The data presented here shows that a vaginal support pessary can improve the daily lives of active women experiencing urine leakage during physical exercise.

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

Safety and Efficacy of a Disposable Vaginal Device for ... Evaluation of the investigative pessary device indicates that the product poses no significant risk to the user and may even be safer than other SUI treatments ...

7. gpm.amegroups.org gpm.amegroups.org/article/view/9639/html

Adverse events in women with neglected vaginal pessaries for ... Although the pessary is a relatively safe and effective treatment option for POP, serious adverse events still can occur such as urinary ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000293780800135X

Efficacy and safety of a novel disposable intravaginal ... The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence ...

9. webmd.com webmd.com/urinary-incontinence-oab/what-are-vaginal-pessaries

Vaginal Pessaries: Types and Use - WebMD A pessary ring supports your pelvic organs if you have stress incontinence (peeing a little when you do certain things like laugh or exercise) ...