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临床试验/NCT03799120
NCT03799120Unknown4 期

The Effect of Daily Versus Twice Per Day Tamsulosin on Ureteral Stent Symptoms Following Ureteroscopy for Nephrolithiasis

Gundersen Lutheran Medical Foundation1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年2月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
80
试验地点
1
主要终点
Ureteric Stent Symptoms Questionnaire

研究概览

简要总结

A single-center prospective, randomized study to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort will be completed.

详细描述

Ureteral stents are commonly used to maintain patency of the ureter and are placed for several common reasons including ureteral obstruction due to nephrolithiasis, cancer, or fibrosis as well as after surgical interventions involving ureteroscopy, ureteral anastomoses or prophylactically prior to extracorporeal shock wave lithotripsy. Ureteral stents have been associated with significant discomfort and dissatisfaction among patients.5 Bosio and colleagues noted that among patients with indwelling stents, 59.1% reported daily urinary frequency ≥ 1 per hour, 90.1% reported ≥ 1 nocturnal micturition episodes, 86.6% reported urinary urgency, and 82.3% reported dysuria. Further, 83.2% complained of pain, mostly in the kidney (67.9%) or in the bladder area (31.3%), particularly during physical activity. Over 90% of patients reported that this pain interfered with their everyday life.

The Ureteric Stent Symptom Questionnaire (USSQ) was developed in 2003 by Joshi and colleagues to quantify patients' discomfort relating specifically to ureteral stents. The USSQ measures several domains relating to stent pain including general health, urinary issues, pain, work performance, sexual matters, and quality of life with stent in situ. The USSQ has been validated and translated and is currently a widely used measure.

While commonly used for treatment of benign prostatic hyperplasia, several studies have evaluated the efficacy of α-blockers for stent pain and have demonstrated a significant improvement in USSQ scores using α-blockers (mean reduction of 8.4 in urinary symptom scores and 7.2 in body pain scores). To date, randomized controlled trials have used one of two types of α-blockers: tamsulosin (0.4mg) vs. alfuzosin (10 mg). In treating benign prostatic hyperplasia, a total maximum dose of 0.8mg tamsulosin is used (either 0.4mg BID or 0.8mg daily), which has shown increased efficacy compared to the 0.4mg QD dose without an increase in adverse effects. Currently, tamsulosin 0.4mg daily is the off-label dosage indicated for lower urinary tract symptoms for patients with an indwelling stent. No study to date, however, has evaluated the clinical impact of a higher daily dose of tamsulosin (0.8mg) on stent-related symptoms. The objective of this study is to assess two different dosing regimens (0.4 mg QD vs. 0.4 mg BID) of tamsulosin for ureteral stent-related discomfort.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 18 and 70 years old.
  • Planning to undergo ureteroscopy with ureteral stent placement at our site.
  • Able to read and understand an English language survey (USSQ).

排除标准

  • Patients who are unable to provide informed consent.
  • Patients who are already taking an alpha-blocker.
  • Patients with hypersensitivity or known adverse side effects of tamsulosin or its ingredients and those who are not candidates for tamsulosin per attending Urologist discretion.
  • Patients with a preexisting bladder condition including UTI within 30 days of the procedure.
  • Patients with hepatitis C on boceprevir.
  • Patients who have medical conditions known to be associated with chronic pain, those taking medications for chronic pain such as gabapentin or a chronic opioid per the judgement of the PI, or those with a pain contract on file.
  • Women who are pregnant or planning to become pregnant.

研究组 & 干预措施

tamsulosin QD + Placebo

Placebo Comparator

0.4 mg tamsulosin QD + Placebo QD

干预措施: Placebo (Other)

tamsulosin BID

Experimental

0.4 mg tamsulosin BID

干预措施: Tamsulosin BID (Drug)

tamsulosin QD + Placebo

Placebo Comparator

0.4 mg tamsulosin QD + Placebo QD

干预措施: Tamsulosin BID (Drug)

结局指标

主要结局

Ureteric Stent Symptoms Questionnaire

时间窗: 1 week post-stent placement

Scales for each question are 1 to 5, with 5 indicated more severe symptoms. Subscale scores are the sum of all questions included in the subscale.

次要结局

未报告次要终点

研究者

发起方
Gundersen Lutheran Medical Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kara Kallies

Academic Researcher / study coordinator

Gundersen Lutheran Medical Foundation

研究点 (1)

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