Study on Solifenacin, Mirabegron, and Their Combination for Treating Overactive Bladder and Daytime Urinary Incontinence in Children Aged 5 to 14 Years

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What is this study about?

This clinical trial is focused on studying the effects of different treatments for children aged 5 to 14 years who have overactive bladder and daytime urinary incontinence. These conditions can cause frequent urges to urinate and accidental leakage of urine during the day. The study will explore the effectiveness of two medications, solifenacin and mirabegron, as well as a combination of both. Solifenacin is a medication that helps relax the bladder muscles, while mirabegron, also known by its code name YM178, works by helping the bladder hold more urine.

The purpose of the study is to evaluate how well these treatments work in reducing the number of wet days, which are days when accidental leakage occurs. Participants will be randomly assigned to receive either solifenacin, mirabegron, a combination of both, or a placebo. The study will last for a total of 18 weeks, with the main treatment period being 12 weeks. During this time, the number of wet days will be monitored to see how the treatments are working. The study will also look at other factors, such as changes in the severity of incontinence and the amount of urine the bladder can hold.

Throughout the study, participants will have regular check-ups to monitor their progress and any side effects. The study aims to provide valuable information on the best treatment options for children with overactive bladder and daytime urinary incontinence, potentially improving their quality of life. Participants will be closely monitored to ensure their safety and well-being during the trial.

1 joining the study

The participant’s legal guardian must sign an informed consent form before any study-specific procedures begin.

The participant must be between 5 and 14 years old and have an overactive bladder with at least two daytime urinary incontinence episodes per week.

The participant should have had inadequate results from four weeks of non-drug treatment and no prior treatment with the study medications.

2 initial assessment

An initial assessment will be conducted to confirm eligibility and establish baseline measurements.

The participant’s ability to swallow the study medication will be evaluated.

3 medication administration

The participant will receive one of the following treatments: solifenacin, mirabegron, or a combination of both.

Solifenacin is provided as a film-coated tablet, and mirabegron as a prolonged-release tablet, both taken orally.

The treatment period lasts for 12 weeks, during which the participant’s response to the medication will be monitored.

4 monitoring and evaluation

The primary outcome is the reduction in the number of wet days per week, assessed every 7 days using a tool called DryPie.

Secondary outcomes include changes in incontinence severity, urge severity, and other bladder function metrics over an 18-week period.

Regular monitoring for any adverse events or unexpected reactions will occur throughout the study.

5 final assessment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall treatment response.

The participant’s progress will be compared to baseline measurements to determine the effectiveness of the treatment.

Who Can Join the Study?

The person responsible for the child must willingly sign a form agreeing to participate in the study before any study-related activities begin.
The child must be between the ages of 5 and 14 years old when the consent form is signed.
The child must have an overactive bladder, which means the bladder muscles contract too often, causing a sudden need to urinate.
The child must have at least 2 episodes of daytime urinary incontinence per week. This means the child has trouble controlling their bladder during the day.
The child must have tried urotherapy for at least 4 weeks without enough improvement. Urotherapy is a non-drug treatment that includes exercises and lifestyle changes to help with bladder control.
The child must not have been treated before with solifenacin, mirabegron, or injections of botulinum toxin into the bladder muscle.
The child must not currently have constipation, which is difficulty in having bowel movements, according to specific medical guidelines called ROME IV, or fecal incontinence, which is trouble controlling bowel movements. However, using laxatives to help with bowel movements is allowed.
The child must be able to swallow or be able to learn how to swallow the study medication, according to the doctor’s opinion.

Who Cannot Join the Study?

Children younger than 5 years old cannot participate.
Children older than 14 years old cannot participate.
Children who do not have daytime urinary incontinence or an overactive bladder cannot participate. Daytime urinary incontinence means having trouble controlling the bladder during the day. Overactive bladder means feeling a sudden urge to urinate that is hard to control.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Lillebaelt Hospital	Kolding	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	11.04.2024

Trial locations

Investigated drugs:

Solifenacin is a medication used to help control an overactive bladder. It works by relaxing the bladder muscles, which can help reduce the urge to urinate frequently and prevent accidents.

Mirabegron is another medication that helps manage an overactive bladder. It works differently from solifenacin by activating certain receptors in the bladder, which helps the bladder hold more urine and reduces the need to urinate urgently.

The combination therapy of Solifenacin and Mirabegron involves using both medications together. This approach aims to provide a more effective treatment for children with overactive bladder and daytime urinary incontinence by combining the benefits of both medications.

Daytime Urinary Incontinence – This condition involves the involuntary leakage of urine during the day. It can occur due to various reasons, including an overactive bladder, which causes a sudden and intense urge to urinate. The bladder muscles may contract involuntarily, leading to urine leakage. This condition is more common in children and can affect their daily activities and social interactions. It may be associated with frequent urination and the inability to hold urine for long periods. Over time, it can impact a child’s confidence and quality of life if not managed properly.

Overactive Bladder – This condition is characterized by a frequent and sudden urge to urinate that is difficult to control. It may lead to involuntary loss of urine, known as urge incontinence. The bladder muscles contract more often than normal, even when the bladder is not full. This can result in frequent trips to the bathroom, both during the day and at night. The condition can affect people of all ages but is more common in older adults. It can significantly impact daily life and activities due to the constant need to find a restroom.

Trial ID:

2023-510187-13-00

Protocol code:

BeDry-2023

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Solifenacin, Mirabegron, and Their Combination for Treating Overactive Bladder and Daytime Urinary Incontinence in Children Aged 5 to 14 Years

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?