Overactive Bladder, Voiding Disorders
Conditions
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).
Interventions
DRUGBeta3-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.
DRUGAnticholinergic drug, Solifenacin
Anticholinergic drugs are widely used to treat overactive bladder by relaxation of bladder wall smooth muscles.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the side effects of the beta 3 agonist drug (Mirabegron) in children. | 6 months | This is planned to assess side effects and safety profile of the beta 3 agonist (Mirabegron) on children (5-18 years) from Egypt. |
| 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. | 6 months | 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. |
| To evaluate correlation between bladder ultrasound findings and severity of patients' symptoms. (normally it is less than 3 mm) | 6 months | 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. |
Contacts
Primary ContactIslam Mansour, MB ChB
Backup ContactAhmed Elhefnawy, PhD
Outcome results
None listed