Safety and Efficacy Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children, a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 70
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Neurogenic or anatomical bladder problems.
- •Patients with contraindications to Beta 3 agonists or anticholinergic drugs.
研究组 & 干预措施
Intervention
This arm will receive standard behavioral therapy plus Mirabegron with adjusted-dose regimen (25-50 mg), patients of 20-40 kg will receive 25-50 mg once a day; patients >40 kg will receive 50 mg once a day, for three months.
干预措施: Beta3-Agonists, Adrenergic (Drug)
Control
This arm will receive will receive standard behavioral therapy plus Solifenacin with a daily dosage of (2.5-10 mg/kg), for three months.
干预措施: Anticholinergic drug, Solifenacin (Drug)
结局指标
主要结局
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.
时间窗: 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.
次要结局
- To evaluate the side effects of the beta 3 agonist drug (Mirabegron) in children.(6 months)
- To evaluate correlation between bladder ultrasound findings and severity of patients' symptoms. (normally it is less than 3 mm)(6 months)
- 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)
研究者
Islam Mansour
Principal invistigator
Mansoura University