Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections
Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections
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).
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.

 Our primary clinical outcome will be the occurrence of objective (bacteriologically
 confirmed) recurrence within 12 months after the start of the treatment. Other outcomes will
 be the occurrence of clinical or symptoms based recurrence; the time to objective or symptoms
 based recurrence, evaluated from the start of the treatment until the first occurrence of an
 objective or symptoms based urinary tract infection, and the overall number of objective or
 symptoms based urinary tract infections experienced within 12 months after treatment
 initiation for RUTI.

 Information about health related quality of life at baseline and 12 months will be recorded
 if available.

 In terms of resource utilization, we will record the number of medical visits, number and
 types of laboratory, imaging and instrumental exams, hospitalization, consumption of
 pharmaceuticals or instrumental therapies (other than intervention and comparator) used
 within 12 months since treatment initiation. Number of days absent from work due to RUTI will
 be recorded when available. Costs will be attributed according to the perspective of the
 National Healthcare System searching for relevant data sources in each country.

 Standard descriptive statistics, such as mean, median, range, and proportions, will be used
 to summarize patient characteristics and other collected variables. The Chi-Square test will
 be used to compare differences in proportions and the Mann-Whitney U test to compare
 continuous variables, with or without logarithmic transformation. The Kaplan-Meier method
 will be used to estimate time to recurrence outcomes.
Inclusion Criteria:

 -  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.