Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

The main objective of the study is to compare efficacy between hyaluronic acid ‐chondroitin sulphate (HA‐CS) treatment and gold standard treatment (AB prophylaxis).Study is set‐up as non‐inferiority, parallel group cross‐over RCT, with a 1:1randomization.Study population: Female (>18rs) with at least 3 symptomatic urinary tract infections(UTI's) in the previous year with no adequate curable therapeutic options.Intervention: 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed bymonthly maintenance therapy for 6 months.Control : oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. In case ofresistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg dailywill be given.All patients recieve both treatments (ialuril and nitrofurantoin) consecutively, for 6months each. The order of the therapies is determined by randomisation. Between therapiesthere is a 4 weeks 'wash‐out' period. A total of 100 patients will be included.During the study patients will fill‐out questionnaires regarding symptoms, quality oflife and use of healthcare. Furthermore urine will be collected at set timepoints.Main study parameters/endpoints: The main study parameter is the number of UTI perpatient‐year. Secondary parameters are time to rUTI (wks.), outcome on the globalresponce assessment (GRA) scale, pattern of antibiotic resistance, outcome on the patientreported outcome questionnaire, cost effectiveness and Quality‐of‐life.