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).
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 1:1 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: 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 6 months. Control : oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given. All patients recieve both treatments (ialuril and nitrofurantoin) consecutively, for 6 months each. The order of the therapies is determined by randomisation. Between therapies there 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months
nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)
Radboudumc
Nijmegen, Gelderland, Netherlands
RECRUITINGRijnstate ziekenhuis
Arnhem, Netherlands
RECRUITINGCanisius wilhelmina ziekenhuis
Nijmegen, Netherlands
RECRUITINGNumber of urinary tract infections
Number of urinary tract infections per patient-year
Time frame: 13 months
Time to first urinary tract infection
Time to first urinary tract infection
Time frame: 13 months
Global Assessment of Improvement
Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)
Time frame: 7 weeks, 3 months, 6 months after start of each therapy
Antibiotics resistance
Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups
Time frame: Baseline, 6 months after start of each therapy
Cost-effectiveness: medical consumption questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'
Time frame: Baseline, 6 months after start of each therapy
Cost-effectiveness: productivity cost questionnaire
Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire'
Time frame: Baseline, 6 months after start of each therapy
Therapy specific patient reported outcomes (symptoms & bother)
Differences in therapy specific patient reported outcomes between both patient groups (measured in Therapy Specific Patient Reported Outcome (PRO) Questionnaire on Symptom \& Bother rUTI \& GAG therapy)
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Time frame: baseline, 7 weeks, 3 months, 6 months after start of each therapy
General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)
Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire
Time frame: baseline, 7 weeks, 3 months, 6 months after start of each therapy