Overview
The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).
Description
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 trial, with a 1:1 randomization.
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: Intervention group (n=50): 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 1 year. Control group (n=50): oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 1 year. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.
During the study patients will fill-out questionnaires regarding symptoms, quality of life 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 per patient-year. Secondary parameters are time to rUTI (wks.), outcome on the global responce assessment (GRA) scale, pattern of antibiotic resistance, outcome on the patient reported outcome questionnaire, cost effectiveness and Quality-of-life.
Eligibility
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