Recurrent Urinary Tract Infection
Conditions
Keywords
GAG therapy, Prophylactic antibiotics
Brief summary
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).
Detailed 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 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.
Interventions
DEVICEIaluril 50ml Prefill
50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months
DRUGNitrofurantoin
nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)
Sponsors
IBSA Institut Biochimique SA
Goodlife Pharma B.V.
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cross-over randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. 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
1. Male 2. \< 18 years 3. Pregnant 4. Already on GAG therapy 5. Already on prophylactic antibiotics 6. Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months 7. Had Gentamicin or other antibiotic instillations in the previous 2 months 8. Allergic to \>3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin) 9. A urinary fistula 10. Urinary stones 11. Urogenital cancer 12. Bladder Pain Syndrome - Interstitial Cystitis 13. Chronic pelvic pain 14. Had a STD untreated or treated in the previous 2 months 15. A urinary diversion 16. An Indwelling catheter 17. A suprapubic catheter 18. Performing \>1/day self-catheterization 19. A residue after voiding (PVR) of \>200ml 20. Unable (also legal) to give informed consent 21. Recurrent urosepsis 22. Multiresistant bacteria in previous urine cultures 23. 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. 24. 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 25. Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD) 26. Does not tolerate catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of urinary tract infections | 13 months | Number of urinary tract infections per patient-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of Improvement | 7 weeks, 3 months, 6 months after start of each therapy | Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best) |
| Antibiotics resistance | Baseline, 6 months after start of each therapy | Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups |
| Cost-effectiveness: medical consumption questionnaire | Baseline, 6 months after start of each therapy | Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire' |
| Time to first urinary tract infection | 13 months | Time to first urinary tract infection |
| Therapy specific patient reported outcomes (symptoms & bother) | baseline, 7 weeks, 3 months, 6 months after start of each therapy | 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) |
| General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression) | baseline, 7 weeks, 3 months, 6 months after start of each therapy | Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire |
| Cost-effectiveness: productivity cost questionnaire | Baseline, 6 months after start of each therapy | Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire' |
Countries
Netherlands
Contacts
Primary ContactDick Janssen, MD, PhD
Backup ContactCléo Baars, MD
Outcome results
None listed