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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Dec 14, 2022

Keywords

ClinConnect Summary

The Gag Therapy for Recurrent Urinary Tract Infection (GT RACING) study is looking at a new treatment method to help prevent repeated urinary tract infections (UTIs) in women. This study compares a special treatment called HA-CS bladder installations to traditional preventive antibiotics, like nitrofurantoin, which is commonly used for UTIs. The goal is to see if the new treatment can be just as effective as these antibiotics in reducing the number of UTIs.

To be eligible for this study, participants must be adult women over 18 years old who have experienced at least three UTIs in the past year and have not had successful treatment options. Participants will need to provide urine samples to confirm their UTIs. If you decide to join the study, you will receive care and monitoring throughout the trial. It’s important to note that there are specific health conditions and treatments that may exclude someone from participating, such as being male, being pregnant, or having certain urinary issues. Overall, this study aims to find better ways to manage recurrent UTIs and improve the quality of life for women affected by this condition.

Gender

FEMALE

Eligibility criteria

• 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

Trial Officials