Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Ureteral Stent Symptom Questionnaire Score
研究概览
简要总结
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.
详细描述
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.
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
- •Patients must be 18 years of age or older
- •Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma
- •Patient must agree to abstain from other clinical studies during the study period
排除标准
- •Patients younger than 18 years of age
- •Patients with chronic or pre-existing indwelling stents
- •Patients currently receiving anticholinergic or alpha blocker therapy
- •Patients with chronic opioid or analgesic usage
- •Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia
- •Patients with an active untreated urinary tract infection
- •Patients who are currently pregnant or nursing
- •Patients with allergies or contraindication to either tamsulosin or hyoscyamine
- •Patients on active chemotherapy
- •Patients currently receiving other investigational therapy
- •Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages)
- •Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal,
- •Any stents placed that will stay in for longer than 2 weeks
研究组 & 干预措施
Hyoscyamine
Hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort
干预措施: Hyoscyamine (Drug)
Tamsulosin
0.4 mg tab orally daily
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Ureteral Stent Symptom Questionnaire Score
时间窗: Three Years
To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated Ureteral Stent Symptom Questionnaire (USSQ).
次要结局
- Additional Medication Needed(Three Years)
- Factors That Determine if Additional Medication Needed(Three Years)
研究者
David Duchene, MD
Associate Professor
University of Kansas Medical Center