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
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | December 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Mansoura University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To evaluate the side effects of the beta 3 agonist drug (Mirabegron) in children. | This is planned to assess side effects and safety profile of the beta 3 agonist (Mirabegron) on children (5-18 years) from Egypt. | 6 months | |
Secondary | 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. | The investigators are planning to translate an Arabic version of the Dysfunctional Voiding Scoring System to use it to assess improvement of symptoms and patient recorded outcomes for Egyptian children before and after receiving Mirabegron. | 6 months | |
Secondary | To evaluate correlation between bladder ultrasound findings and severity of patients' symptoms. (normally it is less than 3 mm) | The investigators are planning to assess Ultrasound measurement of bladder wall thickness as an indicator of severity of patients' symptoms and whether there is bladder wall hypertrophy corresponding to severity of symptoms and whether the bladder wall thickness decreases with treatment. | 6 months |
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