An observational study in Recurrent Urinary Tract Infections, sponsored by Study Group for Urogenital Diseases, Italy. Status unknown at 1 site in Italy. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-02-12.
Sponsored by Study Group for Urogenital Diseases, Italy · Observational
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.
The study will consider women with recurrent urinary tract infections who started their treatments at the Urology Departments at the enrolling centres.
Exclusion criteria:
Intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% once 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.
Device: Ialuril
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.
The treatment is an intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% once 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.
Occurrence of Urinary tract infection recurrence
At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.
Time frame: within 12 months after treatment initiation
Occurrence of symptomatic urinary tract infection recurrence
At least one symptoms based urinary tract infection experienced within 12 months after the treatment initiation.
Time frame: within 12 months after treatment initiation
Mean direct overall costs
Mean overall costs, expressed in euros, comprehensive of costs of each treatment options and other direct medical costs (i.e. visits, additional medical therapies required because of recurrences or adverse events, hospitalization) measured over 12 months after treatment initiation for each cohort of patients.
Time frame: within 12 months after treatment initiation
Number of days absent from work
Number of days of absence from work due to the recurrent urinary tract infections within 12 months since the start of the treatment.
Time frame: within 12 months after treatment initiation
Time-to-recurrence
Time from the start of the treatment until the first occurrence of an objective or symptoms based urinary tract infection
Time frame: 12 months after treatment initiation
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Study Group for Urogenital Diseases, Italy