Clinical trial NCT05240456: Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children
Official title: Safety and Efficacy Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Voiding Disorders
Overactive Bladder
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 6 months.
Secondary outcomes:
measure: To evaluate the side effects of the beta 3 agonist drug (Mirabegron) in children.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
measure: To evaluate correlation between bladder ultrasound findings and severity of patients' symptoms. (normally it is less than 3 mm)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University
name: Islam Mansour, Mb ChB
role: PRINCIPAL_INVESTIGATOR
References: