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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Intravaginal Devices for Urinary Incontinence is an effective treatment?

The available research shows that intravaginal devices, like vaginal pessaries, can be effective for treating urinary incontinence. In one study, 9 out of 20 patients who used a new type of vaginal pessary for one month reported feeling better. Another study found that women who used pessaries for over a year experienced improvements in their quality of life. These devices are also considered a low-risk and effective option for managing pelvic organ prolapse, which is related to urinary incontinence. While there are some risks if not managed properly, with the right training and management, many patients find relief from their symptoms. ^{1 2 3 4 5}

Is the use of intravaginal devices for urinary incontinence generally safe?

Intravaginal devices like pessaries are generally considered safe, but there can be serious complications if they are not managed properly, such as infections or other adverse events. Regular check-ups and proper management can help reduce these risks. ^{2 3 6 7 8}

How does the intravaginal device treatment for urinary incontinence differ from other treatments?

The intravaginal device for urinary incontinence is unique because it is a disposable device that is inserted into the vagina to manage stress urinary incontinence, offering a non-surgical option that can be easily used and removed. Unlike some surgical treatments that may require re-treatment, this device provides a less invasive alternative with the potential for fewer complications. ^{2 3 7 9 10}

Research Team

Linda McLean

Principal Investigator

University of Ottawa

Eligibility Criteria

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

I have a diagnosed neurological condition like stroke or MS.

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

I have had surgery on my urinary or genital organs.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of female urinary incontinence device. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Development of a multinational, multidisciplinary competency framework for physiotherapy training in pessary management: an E-Delphi study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of life in women who use pessaries for longer than 12 months. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Impaction after partial expulsion of a neglected pessary. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Rare complications of pessary use: A systematic review of case reports. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Does monthly self-management of vaginal ring pessaries reduce the rate of adverse events? A clinical audit. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. [2008]