Effect of oral flavoxate on postoperative catheter related bladder dysfunction in adult males undergoing transurethral resection of bladder tumors- A randomized controlled trial vs solifenacin and placebo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Incidence of postoperative catheter related bladder dysfunction
研究概览
简要总结
Catheter related bladder dysfunction (CRBD) is common in male patients after bladder surgery, and involves symptoms of overactive bladder (OAB) including urgency, hesitancy, and pain. Various mechanisms have been postulated for development of CRBD including contraction of the detrusor muscle secondary to acetylcholine release. CRBD is distressing to patients. Several treatment options are available like anti-muscarinics, anti-spasmodics, analgesics, etc. However, no drugs are free from side-effects. Oral flavoxate, an anti-spasmodic has been found to be useful in controlling symptoms of OAB. No previous studies have explored the role of oral flavoxate in managing symptoms of CRBD. Thus, this study aims to evaluate the effect of oral flavoxate vs oral solifenacin on CRBD symptom control, and also to study the side-effect profile of flavoxate vs solifenacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Adult males ASA 2 & 3, posted for elective transurethral resection of bladder tumor surgeries for non-invasive bladder tumors.
排除标准
- •Patient refusal
- •Psychosis
- •Patients on preoperative anti-muscarinic drugs
- •Arrhythmias
- •Patients with pre-operative catheters.
结局指标
主要结局
Incidence of postoperative catheter related bladder dysfunction
时间窗: At 6 hours postoperatively
次要结局
- Incidence of postoperative catheter related bladder dysfunction(At 0 hours, 1 hour, and 2 hours postoperatively)
- Incidence of severe CRBD(At 0, 1, 2, and 6 hours postoperatively)
- Incidence of side effects of the flavoxate and solifenacin like dry mouth, constipation, headache, and dizziness(Until 6 hours postoperatively)
- Visual analog score(Until 6 hours postoperatively)
- Patient satisfaction with the interventions for decreasing catheter related bladder discomfort(At 6 hours)
研究者
Dr Nandyala Tejeswar
AIIMS Bhubaneswar