Clinical trial to compare the efficacy of two therapies (hyaluronic acid/chondroitin sulphate vs. fosfomycin trometamol) in recurrent cystitis prevention.
- Conditions
- Recurrent urinary tract infectionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2014-000906-36-ES
- Lead Sponsor
- aboratorios Gebro Pharma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- Any active infection at the beggining of the study.
- Infection history by fosfomycin trometamol resistant pathogens.
- Antibiotic prophylactic treatment at the moment of the inclusion.
- Treatment with HA-CS 1.6%/2.0% in the last 12 months.
- Increased postvoid residual (>100cc measured by suprapubic ecography)
- Demonstrated organic bladder pathology (bladder cancer, bladder lithiasis,?)
- Neurogenic bladder
- Urinary tract malformation.
- Pregnancy or breastfeeding.
- Use of diaphragm
- Use of spermicides
- Immunosuppression (corticoids, immunosuppressive therapy, immunosuppressive disease)
- Chronic renal failure, stage ?4.
- Allergy or intolerance to any of the studied drugs.
- Active vaginitis
- Patient with hormonal substitutive therapy and/or genital topic hormonal treatment.
- Recent urological intervention (in the last three months)
- Active neoplasic disease.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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.<br>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.;Primary end point(s): Time to recurrence of the infection (defined as time from the beginning of the treatment to the first recurrent infection);Timepoint(s) of evaluation of this end point: At the end of the study (treatment + follow-up)
- Secondary Outcome Measures
Name Time Method 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)