NCT05240456

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Voiding Disorders
• Overactive Bladder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2022-02-15
• Last updated: 2022-02-15