The Effect of Different Injection Site Maps on Intravesical Botulinum Toxin of Bladder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Overactive bladder-V8 questionnaire will be used for efficacy of treatment.
研究概览
简要总结
Botulinum toxin injection into the bladder is used in current practice in urological diseases such as overactive bladder or interstitial cystitis. As far as is known, botulinum toxin injection sites have not been clearly defined. In this study, investigators are planning to compare botulinum toxin effectiveness with different injection site maps.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Interstitial cystitis patients
- •Overactive bladder
排除标准
- •younger than 18 years
研究组 & 干预措施
MAP 1 (Posterior wall only)
Type 1 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal only posterior wall of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
干预措施: Intravesical Botulinum Toxin (Other)
MAP 2 (Posterior wall + bilateral side walls)
Type 2 map injection will be used to bladder in one session. In this arm, Botulinum toxin type A injection will be apply to non-trigonal posterior wall + bilateral side walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
干预措施: Intravesical Botulinum Toxin (Other)
MAP 3 (Non-trigonal all walls)
Type 3 map injection will be used to bladder in one session In this arm, Botulinum toxin type A injection will be apply to non-trigonal all walls of bladder. The application will be done with cystoscopy and, 20 different point will be aimed. Totally 100 IU Botulinum toxin type A will be applied.
干预措施: Intravesical Botulinum Toxin (Other)
结局指标
主要结局
Overactive bladder-V8 questionnaire will be used for efficacy of treatment.
时间窗: Estimated 1 month for every patient after treatment.
The questionnaire contains 8 questions and every question may be scored between 0 and 5. Additionally, male gender get 2 points more. Therefore, a patient may be get between 0 and 42 points. More score means worse complaint.
Urodynamics test will be assessed for efficacy of treatment.
时间窗: Estimated 1 month for every patient after treatment.
Possible bladder contractions and residual volume will be measured in urodynamic testing to demonstrate effectiveness after treatment. The lack of pathological bladder contractions and normal residual urine mean better for patient and, show improving.
次要结局
未报告次要终点