The Efficacy of Pyridostigmine Therapy After Transurethral Resection of Prostate in Cases with Underactive Urinary Bladder: Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Severity of lower urinary tract symptoms
研究概览
简要总结
The efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder
详细描述
Underactive bladder is a decrease in detrusor contraction and/or shortening of the contraction time, resulting in an incomplete and/or prolongation of the bladder emptying within the normal time frame. Prolonged bladder outlet obstruction due to prostatic enlargment one of the main causes of bladder hypocontractility. To make a diagnosis, it is necessary to perform a pressure-flow study. Decrease in maximum urine flow rate related to bladder outlet obstruction or poor contractility can be distinguished by pressure-flow study.
parasympathomimetics (cholinergic receptor stimulating agents) could be beneficial for patients with underactive bladder. However, no systematic review with meta-analysis addressing potential benefits or adverse effects exists. Pyridostigmine is a medication used to treat myasthenia gravis and underactive bladder as well.
Patients with underactive bladder after transurethral resection of prostate may still complain of recurrent attacks of obstructive lower urinary tract symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who are not younger than 45 or older than 75 years.
- •Patients with benign prostatic hyperplasia who are eligible for transurethral resection of prostate.
- •Patients who has decreased bladder contractility confirmed by urodynamic study (pressure flow study) and plotted on international continence society (ICS) nomogram.
排除标准
- •Patients younger than 45 or older than 75 years.
- •Patients who have diabetes.
- •Patients with a history of neurological diseases.
- •patients with a previous history of pelvic surgery.
研究组 & 干预措施
Pyridostigmine group
this group will receive pyridostigmine 60 mg twice daily.
干预措施: Pyridostigmine oral tablet (Drug)
Control group
This will receive placebo postoperatively.
干预措施: Placebo (Drug)
结局指标
主要结局
Severity of lower urinary tract symptoms
时间窗: 1, 2 , 3 months postoperative
Severity of lower urinary tract symptoms will be assessed by International Prostate Symptom Score (IPSS) and expressed in number. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Maximum urine flow rate
时间窗: 1, 2 , 3 months postoperative
Maximum urine flow rate will be assessed by flowmetry and measured by milliliter per second.
Post-void residual volume
时间窗: 1, 2 , 3 months postoperative
Post-void residual volume will be assessed by ultrasound assessment and measured by centimeter cubic.
Bladder contractility evaluation
时间窗: 1, 2 , 3 months postoperative
Bladder contractility will be assessed by urodynamic study. Contractility index is expressed in numbers as follows: strong \> 150, normal 100-150, and weak \< 100.
Bladder detrusor pressure assessment
时间窗: 1, 2 , 3 months postoperative
Bladder detrusor pressure will be assessed by urodynamic study and detrusor pressure measured by CmH2O.
次要结局
未报告次要终点
研究者
Ammar Fathi Mohamed AlOrabi
Doctor
Menoufia University