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临床试验/CTRI/2025/08/092492
CTRI/2025/08/092492尚未招募2 期

A comparative study on the effect of Tamsulosin versus Silodosin in post operative urine retention

Dr Vigneshwaran B1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2025年8月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
334
试验地点
1
主要终点
To evaluate the effect of prophylactic Tamsulosin versus Silodosin in post operative retention of urine

研究概览

简要总结

Those fulfilling the above inclusion and are not in the exclusion criteria will be participants of the study. The participants will be alternatively divided into two groups. The following investigations were carried out in all patients participating in this study i.e. complete blood count, blood urea and serum creatinine, total serum bilirubin, ALP, SGOT, SGPT, ECG, Chest X Ray-PA view, Urine routine, Ultrasound abdomen and pelvis. Patients of General Surgery undergoing abdominal, pelvic, perineal surgeries are given drug prophylaxis either Silodosin in the form 8 mg tablet or Tamsulosin 0.4 mg 12 hours before the procedure to patients. Group A will be given Silodosin . Group B is Tamsulosin. All patients were closely followed for 24 hours post operatively and any voiding difficulties or urinary retention were recorded. Acute urinary retention was diagnosed when a patient was unable to pass urine, feels pain, has a palpable mass in suprapubic region and encouraging the patient to stand up and walk were unsuccessful and urethral catheterization seemed inevitable. The functional outcome will be evaluated based on VAS score in case of Postoperative urine retention, need for urethral catheterization.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients above 40 years of both sexes
  • Patients undergoing abdomen, pelvic, perineal surgeries
  • Patients anaesthetized by general and spinal anaesthesia.

排除标准

  • Patients with symptomatic benign prostate hypertrophy
  • Renal impairment, hepatic impairment
  • Previous neurological disease
  • Urethral stricture, urinary incontinency
  • Patients with indwelling catheter
  • Patients with serum creatinine greater than 1.6mg/dl
  • Prostate cancer, bladder cancer
  • Cardiac related ill patients.

结局指标

主要结局

To evaluate the effect of prophylactic Tamsulosin versus Silodosin in post operative retention of urine

时间窗: Till postoperative period of 24 hours

次要结局

  • To assess the incidence of catheterisation following surgeries with prophylactic Tamsulosin versus Silodosin under general and spinal anesthesia(Till postoperative period of 24 hours)

研究者

发起方
Dr Vigneshwaran B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vigneshwaran B

Sri Manakula Vinayagar Medical College and Hospital, Puducherry

研究点 (1)

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