Randomized, parallel, multicenter, phase IV clinical trial to assess the efficacy of hyaluronic acid/chondroitin sulfate versus fosfomycin trometamol in recurrent urinary tract infection prevention.

INTERVENTION: Trade Name: Fosfomicina Kern Pharma 3g granulado para solución oral EFG Pharmaceutical Form: Granules for oral solution INN or Proposed INN: FOSFOMYCIN TROMETAMOL CAS Number: 78964‐85‐9 Other descriptive name: Fosfomycin trometamol Concentration unit: g gram(s) Concentration type: not less then Concentration number: 3‐ Trade Name: Ialuril Prefill Pharmaceutical Form: Concentrate for intravesical solution INN or Proposed INN: Hyaluronic acid CAS Number: 9004‐61‐9 Other descriptive name: HYALURONIC ACID Concentration unit: % (W/V) percent weight/volume Concentration type: not less then Concentration number: 1.6‐ INN or Proposed INN: CHONDROITIN SULPHATE SODIUM CAS Number: 9082‐07‐9 Other descriptive name: CHONDROITIN SULFATE Concentration unit: % (W/V) percent weight/volume Concentration type: not less then Concentration number: 2‐ CONDITION: Recurrent urinary tract infections Therapeutic area: Diseases [C] ‐ Female diseases of the urinary and reproductive systems and pregancy complications [C13] PRIMARY OUTCOME: Main Objective: To assess the efficacy of instillations of Hyaluronic Acid in combination with Chondroitin sulfate in the presence of Calcium Chloride as excipient vs oral fosfomicyn trometamol in recurrent urinary tract infection prevention. Primary end point(s): Time to recurrence of the infection (defined as time from the beginning of the treatment to the first recurrent infection) Secondary Objective: To assess the quality of life of patients under treatment with hyaluronic acid in combination with chondroitin sulfate in presence of calcium chloride as excipient vs oral fosfomicyn trometamol in recurrent urinary tract infection prevention.; To assess the tolerability of instillations of hyaluronic acid in combination with chondroitin sulfate in presence of calcium chloride as excipient vs oral fosfomycin in recurrent urinary tract infection prevention. Timepoint(s) of evaluation of this end point: At the end of the study (treatment + follow‐up) SECONDARY OUTCOME: Secondary end point(s): Number of UTI per patient, infection/patient/year rate, time to recurrence of the infection from completion of treatment (defined as time from the last dose of treatment taken by the patient to the first recurrent infection)changes in volume and frequency of urination (measured with the bladder diary of 3 days), impact of the treatment in the quality of life (number of sexual relationships, FSFI questionnaire) and subjective evaluation of the urinary symptoms (PUF questionnaire). Control and register of the adverse events. Timepoint(s) of evaluation of this end point: At the end of the study (treatment + follow‐up) INCLUSION CRITERIA: ‐ Females ? 18 years old ‐ At least 3 uncomplicated urinary infections documented by urine culture (>103 UFM/ml) in the last year ‐ Negative urine culture at the beginning of the trial. ‐ Fertile patient that agrees with abstinence or with the use of one contraceptive methods allowed during the trial. The allowed contraceptive methods are: intrauterine device (IUD), condoms, vasectomy and hormonal contraceptives. ‐ Females that give her written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20