A Prospective and Randomized Study of Efficacy and Safety of Transdermal Oxybutynin Versus Oral Oxybutynin in The Management of Children With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
研究概览
简要总结
This is a prospective, randomized controlled clinical trial designed to compare the efficacy and safety of transdermal versus oral oxybutynin in children diagnosed with overactive bladder (OAB) who remain symptomatic despite conservative management. A total of 90 children were planned to be enrolled and randomized to receive either oral oxybutynin suspension or a transdermal oxybutynin patch. The primary outcome was defined as the change in Dysfunctional Voiding and Incontinence Symptom Score (DVISS) from baseline to the end of the treatment period. Secondary outcomes included changes in urinary frequency, voided volume, maximum flow rate (Qmax), and the incidence of adverse events. The study aimed to assess whether the transdermal route of administration provides an alternative therapeutic option with favorable tolerability in pediatric OAB patients.
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
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent symptoms of overactive bladder (OAB) despite at least 3 months of conservative treatment (e.g., behavioral therapy, planned fluid intake, and voiding schedules)
- •No prior medical or surgical treatment for OAB
- •Ability to attend follow-up visits with family/guardian
- •Written informed consent obtained from a legal guardian
排除标准
- •History of febrile or recurrent urinary tract infections
- •Presence of urethral stricture
- •Known or suspected neurogenic bladder dysfunction
- •Previous bladder surgery
- •History of urolithiasis (kidney stones)
- •Contraindications to oxybutynin therapy
研究组 & 干预措施
Oral Oxybutynin
Participants received oral oxybutynin suspension (5 mg, 2-3 times daily depending on body weight) for 3 months.
干预措施: Oral Oxybutynin (Drug)
Transdermal oxybutynin
Participants received transdermal oxybutynin patch (3.9 mg/day) applied twice weekly for 3 months.
干预措施: transdermal oxybutinin (Drug)
结局指标
主要结局
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
时间窗: From enrollment to the end of treatment at three months
The primary outcome was the change in DVISS score, a validated questionnaire assessing lower urinary tract symptoms in children. Scores range from 0 to 35, with higher scores indicating more severe symptoms.
次要结局
未报告次要终点
研究者
Ahmet Halil Sevinc
MD - Urology Specialist
Dr. Lutfi Kirdar Kartal Training and Research Hospital