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临床试验/NCT01884467
NCT01884467Unknown4 期

Randomized Placebo-Controlled Trial of Gentamicin Bladder Instillation for the Prevention of Urinary Tract Infection in Adults at High Risk for Cystitis Due to Intermittent Catheterization

Gillette Children's Specialty Healthcare1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
24
试验地点
1
主要终点
Symptomatic UTI

研究概览

简要总结

Recurrent UTIs are common among patients on IC. These create significant patient morbidity and healthcare burden. In desperation, many physicians prescribe prophylactic oral or intravesical antibiotics. This practice is common among our Gillette clinic patients. However, the benefit is unclear and the risks are not insignificant. As such, practice variation is significant. In order to better define the evidence for or against gentamicin bladder irrigation and thus inform clinical practice both locally at our Gillette urology clinic and for practitioners at large we will pursue the following specific aims:

  1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among a population of Gillette patients on IC with and without gentamicin bladder instillation.
  2. Compare antibiotic resistance rates among a population of Gillette patients on IC with and without gentamicin bladder instillation.

详细描述

In the Gillette Lifetime Urology clinic, gentamicin bladder instillation (GBI) for UTI prophylaxis is common practice among our neurogenic bladder patients in IC. However, as previously shown, the evidence supporting this practice is mixed. Potential risks of this practice include wasted costs, wasted materials, wasted time and growing antibiotic resistance. Potential benefits include reduced use of systemic antibiotics, a reduction in symptomatic UTIs and fewer hospitalizations for febrile UTIs. We seek to define the evidence for or against this practice by completing a double-blind randomized controlled trial of GBI vs. NS instillation. Such a trial would benefit our Gillette patients and the community of patients on IC worldwide.

Recurrent UTIs are common among patients on IC. These create significant patient morbidity and healthcare burden. In desperation, many physicians prescribe prophylactic oral or intravesical antibiotics. This practice is common among our Gillette clinic patients. However, the benefit is unclear and the risks are not insignificant. As such, practice variation is significant. In order to better define the evidence for or against gentamicin bladder irrigation and thus inform clinical practice both locally at our Gillette urology clinic and for practitioners at large we will pursue the following specific aims:

  1. Compare rates of symptomatic urinary tract infection and asymptomatic bacteriuria among a population of Gillette patients on IC with and without gentamicin bladder instillation.
  2. Compare antibiotic resistance rates among a population of Gillette patients on IC with and without gentamicin bladder instillation.

研究设计

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

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (>=16 years of age) with any diagnosis on IC of the bladder.
  • Patients may catheterize either thru the urethra or a stoma (e.g. Mitrofanoff).
  • A history of recurrent symptomatic UTI's (at least 3 per year).
  • Patient must be able to travel to Gillette's Lifetime clinic for quarterly urine cultures
  • Patient must have an "informed other" that can supplement any missing study information (incident UTI, treatment information, etc.)

排除标准

  • Patients currently on oral or intravesical antibiotic prophylaxis refusing to or not able to discontinue prophylaxis.
  • Patients colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy.

研究组 & 干预措施

Gentamicin

Experimental

Intervention: Gentamicin; Dosage form: 120mg reconstituted in 250cc of normal saline; Dosage: 30mL; Frequency: nightly instillation into bladder (to remain overnight until draining it out in morning); Duration: 1 year

干预措施: Gentamicin (Drug)

Placebo

Placebo Comparator

Drug: Normal saline; Dosage form: N/A; Dosage: 30 mL; Frequency: nightly bladder instillation; Duration: 1 year

干预措施: Placebo (Drug)

结局指标

主要结局

Symptomatic UTI

时间窗: one year

Our primary outcome will be febrile or symptomatic UTI, defined as fever or abdominal pain or new bladder symptoms such as pain, urinary incontinence, hematuria or more frequent bladder spasms plus urine culture demonstrating \>103 CFUs of a single dominant bacteria or \>105 of multiple bacteria.

次要结局

  • Asymptomatic UTI(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean P. Elliott, M.D., M.S.

Associate Professor and Vice Chair, Director of Reconstructive Urology, University of Minnesota

Gillette Children's Specialty Healthcare

研究点 (1)

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