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临床试验/NCT03077711
NCT03077711已完成4 期

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

NorthShore University HealthSystem1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
92
试验地点
1
主要终点
Recurrent UTI

研究概览

简要总结

Several methods are available for use in the prevention of recurrent urinary tract infections (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs. However, this data is now about 10 years old. Increasing use of antibiotics over the years has lead to increased resistance of bacteria. In addition, long-term antibiotic use has several adverse effects, some life-threatening. There is recent literature evaluating the use of several of the alternatives to suppressive antibiotics with mixed results. A comparative study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the current literature. Several early partly-randomized trials done with methenamine hippurate have shown promising results, but are only as recent as 1987. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics. The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a given 1 year time period. The long-term goals of this study are to find an alternative to using suppressive antibiotics, potentially with a lower adverse effect profile and less of the dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would also tackle the issue of antibiotic resistance.

详细描述

Hypothesis:

The hypothesis of this study is that the group taking trimethoprim will have a lower recurrence rate than those taking methenamine hippurate based on the literature. The investigators aim to identify to what degree that difference is and whether or not it is an acceptable difference given the greater degree of an antibiotic resistance.

Objectives:

The primary objective of this prospective, randomized study is to determine whether there is a significant difference in the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive antibiotics independent of vaginal estrogen use.

The secondary objective of this study is to determine how well patients are able to tolerate each of these medications and what adverse effects are observed in a 1 year time period.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • recurrent UTI: at least 2 in the past 6 months or 3 in past year (culture positive)
  • must have been symptomatic with dysuria, urgency, frequency, suprapubic pain, hematuria, malodorous urine
  • treated for last UTI and negative urine culture on entry into study
  • English speaking

排除标准

  • pregnancy
  • urinary tract abnormalities (eg kidney stones)
  • acute pyelonephritis
  • renal insufficiency or failure
  • known allergy to medications
  • prophylaxis for post-coital recurrent UTIs

研究组 & 干预措施

Patients with recurrent UTIs arm 1

Active Comparator

Patients are randomized to receive methenamine hippurate in one arm if they are diagnosed with recurrent urinary tract infections.

干预措施: Methenamine hippurate (Drug)

Patients with recurrent UTIs arm 2

Active Comparator

Patients are randomized to receive trimethoprim in the other arm if they are diagnosed with recurrent urinary tract infections.

干预措施: Trimethoprim (Drug)

结局指标

主要结局

Recurrent UTI

时间窗: up to 12 months

The number of patient who had a recurrence of UTI within 12 months

Number of Infections

时间窗: up to 12 months

The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture.

Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI

时间窗: up to 12 months

Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.

次要结局

  • Morisky Medication Adherence Survey(up to 12 months)
  • Adverse Effects(up to 12 months)
  • Bacterial Infection Prevalence and Types(up to 12 months)

研究者

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

Carolyn Botros

Female Pelvic Medicine and Reconstructive Surgery

NorthShore University HealthSystem

研究点 (1)

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