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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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 The study will track their progress and any changes in their condition after the medication is withdrawn.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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Solifenacin

    Solifenacin is administered orally in tablet form and is used to treat daytime urinary incontinence. It is currently well-established in medical practice and literature as a treatment for overactive bladder symptoms. The medication works by blocking specific receptors in the bladder, reducing muscle contractions and increasing bladder capacity. It belongs to the pharmacological class of antimuscarinics.

  • Mirabegron

    Mirabegron is taken orally as a tablet and is used to manage daytime urinary incontinence. It is recognized in medical literature as an effective treatment for overactive bladder. The drug functions by stimulating certain receptors in the bladder, which helps relax the bladder muscle and increase its storage capacity. Mirabegron is classified as a beta-3 adrenergic agonist.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-510280-35-00Protocol codeStayDry-2023Estimated enrolment216 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).