Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study (GT RACING)
Recurrent Urinary Tract Infection
About this trial
This is an interventional prevention trial for Recurrent Urinary Tract Infection focused on measuring GAG therapy, Prophylactic antibiotics
Eligibility Criteria
Inclusion Criteria: Adult female patients (>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g. bladder stones) At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture. Exclusion Criteria: Male < 18 years Pregnant Already on GAG therapy Already on prophylactic antibiotics Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months Had Gentamicin or other antibiotic instillations in the previous 2 months Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin) A urinary fistula Urinary stones Urogenital cancer Bladder Pain Syndrome - Interstitial Cystitis Chronic pelvic pain Had a STD untreated or treated in the previous 2 months A urinary diversion An Indwelling catheter A suprapubic catheter Performing >1/day self-catheterization A residue after voiding (PVR) of >200ml Unable (also legal) to give informed consent Recurrent urosepsis Multiresistant bacteria in previous urine cultures Contra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR < 30), lung- or liver problems or neuropathy after previous use of nitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesium trisilicate. Contra-indications and interactions for trimethoprim: severe kidney or liver dysfunction, blood count abnormality, use of vitamin K antagonists, use of folic acid antagonists, use of ace inhibitors Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD) Does not tolerate catheterization
Sites / Locations
- RadboudumcRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention group
Control group
50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 1 year
nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.