Intravaginal Devices for Urinary Incontinence

Recruiting in Palo Alto (17 mi)

Overseen by Linda McLean

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Ottawa

Disqualifiers: Pain, Urogenital surgery, Neurologic disorder, others

No Placebo Group

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.

Trial 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 (Behavioural Intervention)
• Tampon Intervention (Behavioural 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

McLean Function Measurement Lab Ottawa, Canada

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials

231

Patients Recruited

267,000+

References

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

Pessary use and management for pelvic organ prolapse. [2009] Pessary is a low-risk and effective non-surgical treatment option for pelvic organ prolapse. Indications for pessary include symptomatic prolapse, if surgery is not desired or recommended, and use as a diagnostic tool to predict surgical outcomes. Evidence for pessary selection and management is incomplete so trial and error, expert opinion, and experience remain the best guides for use and management of the pessary. With proper training and understanding of pessary management, most patients can be successfully fitted and taught to manage the pessary either for short- or long-term relief of symptoms. Patient satisfaction is high making pessary an important tool in treating prolapse.

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

Evaluation of female urinary incontinence device. [2019] A new silicone rubber inflatable vaginal pessary has been evaluated in 33 patients with stress incontinence due to urethral sphincter dysfunction (genuine stress incontinence), confirmed by urodynamic assessment. Nine of 20 patients who used the device for one month showed subjective improvement and 2 patients have continued to use the device. Urodynamic changes include a marked increase in maximum urethral closure pressure and elevation of the bladder neck.

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] Vaginal support pessaries are intravaginal devices designed to relieve symptoms of pelvic organ prolapse, but they can cause serious medical complications if not managed well. Physiotherapists are well placed to manage pessaries, but there are no guidelines on the training required for competency in pessary management (PM).

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

Quality of life in women who use pessaries for longer than 12 months. [2016] Pessaries are an effective treatment for pelvic organ prolapse and urinary incontinence; however, few data exist describing long-term pessary use. Our aim was to describe symptom bother and quality of life (QoL) in women using pessaries for urinary incontinence and/or prolapse for at least 12 months.

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

Impaction after partial expulsion of a neglected pessary. [2021] Vaginal pessaries are effective for treating pelvic organ prolapse, and severe complications are rare. We describe an exceptional case of pessary impaction with partial expulsion.

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

Rare complications of pessary use: A systematic review of case reports. [2022] Pessaries are desirable for its overall safety profiles. Serious complications have been reported; however, there is little summative evidence. This systematic review aimed to consolidate all reported serious outcomes from pessaries usage to better identify and counsel patients who might be at higher risk of developing these adverse events.

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] A pessary is a silicone ring placed on the vagina that can improve urinary incontinence. This study reports an 83-year-old patient with a pessary discovered inside her vagina after a prior urinary incontinence treatment. The prolonged presence of the pessary in the patient's body led to a complication called urosepsis. The presence of the pessary inside the patient's vagina for an extended period was not detected by the doctor who performed the gynecological checks, nor by the patient who had forgotten about it. The pessary remained inside her for 10 years until it was discovered accidently during a hysterectomy.

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] To determine the rate of adverse events (AE) in women who self-manage their vaginal ring pessary on a monthly basis. We hypothesised that the AE rate would be lower compared to previously published traditional management protocols.

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

New approach to the management of stress urinary incontinence in patients with treatment failure. [2016] Urinary incontinence affects about 40 million adults in the Western world. Many mechanical, behavioral, and surgical approaches have been used for its treatment. Many of the surgical techniques are successful, but about 50% of patients need re-treatment after 5 to 7 years. Although intraurethral plug-like devices could block the leak, they create a communication between the bladder and vulva, resulting in high rates of ascending urinary infections. To prevent this communication but block the bladder outlet while allowing it to open voluntarily, a new intravesical device was designed. The device could be inserted easily into the bladder of 35 patients and activated using a remote control. The use of a completely intravesical device for the management of anatomic incontinence is a novel approach. The results obtained in pilot studies showed that the device is effective in the management of stress incontinence in patients who were failures after surgery or who refused surgery.

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

Efficacy and safety of a novel disposable intravaginal device for treating stress urinary incontinence. [2008] The purpose of this study was to evaluate the efficacy and safety of a novel disposable intravaginal device for treatment of stress urinary incontinence (SUI) in women.