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

NCT05240456 | Unknown Phase 1 DMC

• 1 other identifier: MS.21.09.1680
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Voiding Disorders; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Beta 3 agonist drug (Mirabegron) in improving symptoms of children with voiding dysfunction using dysfunctional voiding scoring system as a primary measure.

  To evaluate the 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. This score consists of 10 voiding dysfunction parameters that are assigned scores of 0 to 3 according to prevalence, and possible total scores ranging from 0 to 30. The higher the score, the more severe the symptoms of voiding dysfunction. The documented cutoff score for voiding dysfunction is 6 and 9 for females and males respectively.

  6 months.

Secondary Outcomes (3)

• To evaluate the side effects of the beta 3 agonist drug (Mirabegron) in children.

  6 months

• To validate an Arabic version of the Dysfunctional Voiding Scoring System as the documented cutoff score for voiding dysfunction is 6 and 9 for females and males respectively.

  6 months

• To evaluate correlation between bladder ultrasound findings and severity of patients' symptoms. (normally it is less than 3 mm)

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Drug: Beta3-Agonists, Adrenergic

Control

ACTIVE COMPARATOR

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

Drug: Anticholinergic drug, Solifenacin

Interventions

Beta3-Agonists, Adrenergic 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.

Also known as: Standard behavioral Urotherapy

Intervention

Anticholinergic drug, Solifenacin DRUG

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

Also known as: Standard behavioral Urotherapy

Control

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Neurogenic or anatomical bladder problems.
• Patients with contraindications to Beta 3 agonists or anticholinergic drugs.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Adrenergic beta-3 Receptor Agonists; Cholinergic Antagonists; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Cholinergic Agents; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Islam Mansour, Mb ChB

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Islam Mansour, MB ChB

CONTACT

+201147800607; islamreda2205@gmail.com

Ahmed Elhefnawy, PhD

CONTACT

+201224285870; a_s_elhefnawy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invistigator

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: February 15, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share