Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms
研究概览
简要总结
The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications.
Main objective:
• To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms.
Secondary objectives:
- To assess differences in Body pain, General health, Work performance, Sexual matters, and Additional problems using a questionnaire (USSQ).
- To assess differences in side effects.
After stent placement, subjects will be randomly assigned to one of three groups:
- Terazosin (alpha-blocker) for 14 days
- Tamsulosin (alpha-blocker) for 14 days
- Standard of care (no alpha-blocker). All subjects will be discharged with standard pain-killers and a diary to track usage. Subjects in Terazosin and Tamsulosin groups will receive respective study medications to complete 14 days course of treatment.
Follow-Up:
- Day 7: A phone call will check medication use and any side effects.
- Day 15: Clinic visit for stent removal (standard practice). Subjects will complete the USSQ questionnaire, and medication compliance will be reviewed.
End of study: Final phone call to check for any additional side effects.
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
- •Malaysian age 18 years old and above.
- •Able to provide written informed consent to participate in the trial.
- •Willing to comply with study procedures.
- •Unilateral intracorporeal lithotripsy procedure with ureteral stent placement for uncomplicated ureteric or renal calculi
排除标准
- •Known comorbidity that increase the risk of complication
- •Prostate pathology: Benign prostate hyperplasia, prostatitis, prostatic carcinoma
- •Bladder pathology: Bladder tumor, stone, overactive bladder
- •Ureteral abnormality/ trauma, urethral stricture
- •Concomitant urinary tract infection
- •Orthostatic hypotension
- •Solitary kidney
- •Previous pelvic/ gynaecological surgery
- •Patient is concomitantly receiving treatment from a pain clinic for chronic pain management.
- •Pregnancy (for women of childbearing potential)
- •Known history of allergic reactions to tamsulosin or terazosin
- •Patient is concomitantly taking warfarin or H2 receptor blockers
- •Patients with clinical condition(s) judged by the researcher/ clinician to be unsuitable for participation in the study
研究组 & 干预措施
Terazosin
Terazosin 2mg ON
干预措施: Terazosin (Drug)
Tamsulosin
Tamsulosin 0.4mg ON
干预措施: Tamsulosin (Drug)
结局指标
主要结局
To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting urinary symptoms
时间窗: From randomization to the end of the treatment at 14 days
Ureteral Stent Symptom Questionnaire (USSQ)- "Urinary Symptom score" domain. This domain focuses on issues related to urine storage and voiding, including symptoms such as weak stream, intermittent, incomplete empty, straining to start, frequency of spasm, urgency, nocturia, dysuria, hematuria, urge incontinence and impact quality of life. Each symptom is scored, with higher score indicating more severe symptoms. The total score ranges from 11 ( best outcome) to 56 (worst outcome).
次要结局
- To determine the difference in analgesic requirement(From randomization to the end of the treatment at 14 days)
- To determine the efficacy of Terazosin, Tamsulosin and standard of care in reducing post-stenting: Body pain, General health Work performance, Sexual matters, Additional problems(From randomization to the end of the treatment at 14 days)
- To describe the difference in adverse events(From randomization to the end of the treatment at 14 days)
研究者
Ooi Yeon Wee
Doctor
Penang Hospital, Malaysia