Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-12-31

Brief Summary

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A randomized clinical study to evaluate the safety and efficacy of using the Beta 3 agonist drug (Mirabegron) combined with standard behavioral therapy in comparison to using the anticholinergic drug (Solifenacin) combined with behavioral therapy, for children with non-neurogenic voiding dysfunction refractory to behavioral therapy alone, using improvement of dysfunctional voiding symptom score as a primary measurement of efficacy.

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Detailed Description

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The study aims to evaluate the beta 3 agonist drug (Mirabegron) as regard its safety and efficacy when used in children with non neurogenic voiding dysfunction, including children suffering from frequency, urgency, urgency incontinence and hesitancy who do not have neurological disease explaining these symptoms and who failed behavioral urotherapy.

The patients will be randomly allocated into two groups, one will receive standard behavioral therapy plus Mirabegron, the other will receive standard behavioral therapy plus the anticholinergic drug Solifenacin for three months. Patients will be assessed initially and after three months using:

* Medical and voiding history (bladder voiding diary, Dysfunctional voiding symptom score (DVSS) , Bristol Stool Scale)
* Dysfunctional voiding symptom score (DVSS) , Bristol Stool Scale
* Urine analysis and mid-stream urine culture.
* Uroflowmetry.
* Pelvic US and post-void residual urine (PVR).

Conditions

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Voiding Disorders Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention

This arm will receive standard behavioral therapy plus Mirabegron with adjusted-dose regimen (25-50 mg), patients of 20-40 kg will receive 25-50 mg once a day; patients \>40 kg will receive 50 mg once a day, for three months.

Group Type EXPERIMENTAL

Beta3-Agonists, Adrenergic

Intervention Type DRUG

The beta 3 agonist ,Mirabegron, has been shown to be effective for the treatment of OAB in adults through relaxation of bladder wall, with few side effects. This intervention aims to evaluate its efficacy and safety for children with non-neurogenic voiding dysfunction.

Control

This arm will receive will receive standard behavioral therapy plus Solifenacin with a daily dosage of (2.5-10 mg/kg), for three months.

Group Type ACTIVE_COMPARATOR

Anticholinergic drug, Solifenacin

Intervention Type DRUG

Anticholinergic drugs are widely used to treat overactive bladder by relaxation of bladder wall smooth muscles.

Interventions

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Beta3-Agonists, Adrenergic

The beta 3 agonist ,Mirabegron, has been shown to be effective for the treatment of OAB in adults through relaxation of bladder wall, with few side effects. This intervention aims to evaluate its efficacy and safety for children with non-neurogenic voiding dysfunction.

Intervention Type DRUG

Anticholinergic drug, Solifenacin

Anticholinergic drugs are widely used to treat overactive bladder by relaxation of bladder wall smooth muscles.

Intervention Type DRUG

Other Intervention Names

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Standard behavioral Urotherapy Standard behavioral Urotherapy

Eligibility Criteria

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Inclusion Criteria

* Children with non-neurogenic voiding dysfunction predominantly filling phase dysfunctions or OAB, refractory to behavioral therapy as a primary monotherapy, with dysfunctional voiding symptom score of ≥6 for females and ≥9 for males, between the age of 5 \& 18 years old.