The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 主要终点
- As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
研究概览
简要总结
The researchers investigated the effectiveness and safety of BoNT/A injected into the detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity unresponsive to conventional medical therapy.
详细描述
Patients included will have overactive bladder symptoms refractory to medical therapy. Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. None of the patients will be under anticoagulant therapy or drugs interfering with neuromuscular transmission. The study was approved by the local ethical committee and patients gave their informed consent. Patients will be informed about the possible need for intermittent catheterization after BoNT/A treatment.
As outcome measures we assessed clinical and urodynamic variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with overactive bladder symptoms refractory to medical therapy.
排除标准
- •Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded.
- •Concomitant anticoagulant therapy or drugs interfering with neuromuscular transmission.
- •Neuromuscular disease like Lambert-Eaton syndrome.
研究组 & 干预措施
Botulinum A toxin
Botulinum A toxin intravesical injection
干预措施: Intravesical injection of Botulinum A toxin (Drug)
结局指标
主要结局
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
时间窗: One, three and five months after intravesical treatment
次要结局
- Urodynamic assessment, and samples were obtained for urinalysis and culture.(One, three and five months follow up)