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

NCT05240456 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-02-15

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Anticholinergic drug, Solifenacin

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Islam Mansour, Mb ChB · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-07-31
Completion
2022-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240456 on ClinicalTrials.gov