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Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections (RAISC-RUTI)

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ClinicalTrials.gov Identifier: NCT02016118
Recruitment Status : Unknown
Verified February 2014 by Massimo Lazzeri, Study Group for Urogenital Diseases, Italy.
Recruitment status was:  Recruiting
First Posted : December 19, 2013
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Massimo Lazzeri, Study Group for Urogenital Diseases, Italy

Tracking Information
First Submitted Date October 7, 2013
First Posted Date December 19, 2013
Last Update Posted Date February 12, 2014
Study Start Date January 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2013)
Occurrence of Urinary tract infection recurrence [ Time Frame: within 12 months after treatment initiation ]
At least one bacteriologically confirmed urinary tract infection experienced within 12 months after the treatment initiation.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02016118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2013)
Occurrence of symptomatic urinary tract infection recurrence [ Time Frame: within 12 months after treatment initiation ]
At least one symptoms based urinary tract infection experienced within 12 months after the treatment initiation.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 14, 2013)
  • Mean direct overall costs [ Time Frame: within 12 months after treatment initiation ]
    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.
  • Number of days absent from work [ Time Frame: within 12 months after treatment initiation ]
    Number of days of absence from work due to the recurrent urinary tract infections within 12 months since the start of the treatment.
  • Time-to-recurrence [ Time Frame: 12 months after treatment initiation ]
    Time from the start of the treatment until the first occurrence of an objective or symptoms based urinary tract infection
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Retrospective Analysis of Ialuril vs. Standard of Care in Recurrent Urinary Tract Infections
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)
Brief Summary 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).
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study will consider women with recurrent urinary tract infections who started their treatments at the Urology Departments at the enrolling centres.
Condition Recurrent Urinary Tract Infections
Intervention Device: Ialuril
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.
Study Groups/Cohorts
  • Ialuril
    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.
    Intervention: Device: Ialuril
  • Standard of care
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 14, 2013)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02016118
Other Study ID Numbers RAISC-RUTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Massimo Lazzeri, Study Group for Urogenital Diseases, Italy
Study Sponsor Study Group for Urogenital Diseases, Italy
Collaborators Not Provided
Investigators
Principal Investigator: Massimo Lazzeri, PhD Università Vita-Salute San Raffaele
PRS Account Study Group for Urogenital Diseases, Italy
Verification Date February 2014