Study on Stopping Solifenacin and Mirabegron for Children with Daytime Urinary Incontinence

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What is this study about?

This clinical trial is focused on studying daytime urinary incontinence in children. The trial will explore the effects of stopping medication treatment for this condition. The medications involved in the study are solifenacin succinate and mirabegron. Solifenacin succinate, also known by its code name YM-905, is a medication that helps relax the bladder by blocking certain receptors. Mirabegron, also known as YM178, works by activating specific receptors in the bladder to help it hold more urine.

The purpose of the study is to determine if stopping these medications suddenly or gradually affects the likelihood of the incontinence returning. Participants in the study will either stop taking their medication all at once or gradually reduce their dosage over time. The study will monitor the recurrence of incontinence over a period of up to 12 months. Additionally, the study will look for any symptoms that might occur when the medication is stopped.

Participants will be children who have been successfully treated for urinary incontinence with solifenacin and/or mirabegron. The study will track their progress and any changes in their condition after the medication is withdrawn. The goal is to better understand how to manage the discontinuation of these treatments in children who have achieved continence.

1 joining the study

Upon joining the study, the participant’s legal guardian must provide informed consent. This is a formal agreement to participate in the study after understanding all relevant information.

The participant must be between 5 and 14 years old and have been diagnosed with daytime urinary incontinence.

2 initial assessment

An initial assessment will confirm that the participant has achieved continence using the medications solifenacin and/or mirabegron.

The participant must have maintained continence on the same dosage of medication for at least three months.

3 withdrawal phase

The study will compare two methods of stopping the medication: abrupt withdrawal and phased withdrawal.

The goal is to determine if the method of withdrawal affects the risk of incontinence returning.

4 monitoring period

After withdrawal, the participant will be monitored for up to 12 months to check for any recurrence of incontinence.

A 14-day calendar will be used to record any episodes of incontinence.

5 assessment of withdrawal symptoms

The study will also assess any withdrawal symptoms using a questionnaire.

This assessment will take place up to 44 days after the start of the withdrawal process.

Who Can Join the Study?

  • The person responsible for the participant must willingly sign and date a form agreeing to take part in the study before any study-related activities begin.
  • The participant must be between the ages of 5 and 14 years old at the time of signing the consent form.
  • The participant must have been diagnosed with urinary incontinence according to specific medical guidelines. Urinary incontinence means having trouble controlling the bladder during the day.
  • The participant must be receiving medication treatment with solifenacin and/or mirabegron. These are medicines used to help control bladder problems.
  • The participant must have achieved control over their bladder issues while on the medication solifenacin and/or mirabegron.
  • Previous attempts to stop the medication are allowed.
  • The participant must have maintained bladder control on the same dose of medication for at least three months.

Who Cannot Join the Study?

  • Patients who are not experiencing daytime urinary incontinence, which means having trouble controlling the bladder during the day.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark

Other Sites

Site Name City Country Status
Lillebaelt Hospital Kolding Denmark
Aalborg University Hospital Aalborg Denmark
Region Midtjylland Aarhus Denmark
Ahujuu Uieeyrybwq Hmzbendp Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
10.03.2024

Trial locations

Solifenacin is a medication used to treat urinary incontinence. It works by relaxing the bladder muscles, which helps to reduce the urge to urinate and prevents involuntary leakage of urine. In this trial, researchers are studying how stopping this medication suddenly or gradually affects the return of incontinence symptoms in children.

Mirabegron is another medication used to manage urinary incontinence. It helps by relaxing the bladder and increasing its capacity to hold urine, which reduces the frequency and urgency of urination. The trial is examining whether stopping this medication abruptly or in a phased manner impacts the likelihood of incontinence returning in children.

Daytime Urinary Incontinence – This condition involves the involuntary leakage of urine during the day. It can occur due to various reasons, such as weakened pelvic muscles, nerve damage, or an overactive bladder. Individuals with this condition may experience sudden urges to urinate and may not reach the bathroom in time. The severity can vary, with some experiencing occasional leaks and others having more frequent episodes. It can affect daily activities and may lead to embarrassment or social anxiety. The condition can progress if underlying causes are not addressed, leading to increased frequency or volume of leakage.

Trial ID:
2023-510280-35-00
Protocol code:
StayDry-2023
Trial Phase:
Therapeutic confirmatory (Phase III)

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