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临床试验/NCT02016118
NCT02016118Unknown不适用

INTRAVESICAL ADMINISTRATION OF COMBINED HYALURONIC ACID (HA) AND CHONDROITIN SULPHATE (CS) vs. STANDARD OF CARE FOR THE TREATMENT OF RECURRENT URINARY TRACT INFECTIONS (RUTIs)

Study Group for Urogenital Diseases, Italy1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Occurrence of Urinary tract infection recurrence

研究概览

简要总结

The purpose of this study is to assess the effectiveness and costs associated with the intravesical administration of combined hyaluronic acid (HA) and chondroitin sulphate (CS) compared to the current standard management of recurrent urinary tract infections in adult women diagnosed with recurrent urinary tract infections (RUTI).

详细描述

RUTI is defined as at least three episodes of uncomplicated urinary tract infections accompanied by clinical symptoms and documented by urine culture with the isolation of >103 colony forming units (CFU)/ml of an identified pathogen in the last year (M. Grabe, T.E. Bjerklund-Johansen, H. Botto, B. Wullt, M. Çek, K.G. Naber, R.S. Pickard, P. Tenke, F. Wagenlehner. Guidelines on Urological Infections. European Association of Urology 2012).

In order to do so, we will perform a retrospective analysis on prospectively collected patient data in nine European centres.

The treatment schedule for the intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% is one instillation per week for the first month, followed by one instillation every two weeks for the second month and one instillation per month until stable remission of the symptoms.

The current standard management of RUTI in Europe is represented by the antimicrobial prophylaxis (continuous or postcoital), as described in the Guidelines on Urological Infections of the European Association of Urology or Immunoactive prophylaxis or Prophylaxis with probiotics or Prophylaxis with cranberry, or combination of these.

We will collect patient characteristics as age, BMI, sexual activity, employment status, severity of the disease, comorbidities.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-75 years old.
  • Women diagnosed with recurrent urinary tract infections, defined as at least three episodes of uncomplicated urinary tract infections accompanied by clinical symptoms and documented by urine culture with the isolation of >103 CFU/ml of an identified pathogen in the last year. Uncomplicated or 'simple' UTI is defined as an infection in a person with normal urinary tract and function.
  • Exclusion criteria:
  • Women with complicated urinary tract infections. Complicated urinary tract infection occurs in individuals with functional or structural abnormalities of the genitourinary tract.

排除标准

  • 未提供

结局指标

主要结局

Occurrence of Urinary tract infection recurrence

时间窗: within 12 months after treatment initiation

At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.

次要结局

  • Occurrence of symptomatic urinary tract infection recurrence(within 12 months after treatment initiation)

研究者

发起方
Study Group for Urogenital Diseases, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Lazzeri

MD, PhD Consultant

Study Group for Urogenital Diseases, Italy

研究点 (1)

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