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

Overactive Bladder Clinical Trial

Official title:
Safety and Efficacy Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children, a Randomized Clinical Trial

Clinical Trial 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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05240456
Study type Interventional
Source Mansoura University
Contact Islam Mansour, MB ChB
Phone +201147800607
Email islamreda2205@gmail.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date February 2022
Completion date December 2022
View Details
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