Recurrent Urinary Tract Infections Clinical Trial
Official title:
INTRAVESICAL ADMINISTRATION OF COMBINED HYALURONIC ACID (HA) AND CHONDROITIN SULPHATE (CS) vs. STANDARD OF CARE FOR THE TREATMENT OF RECURRENT URINARY TRACT INFECTIONS (RUTIs)
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.
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Observational Model: Case Control, Time Perspective: Retrospective
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