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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University Medical Center
• Collaborators: Goodlife Pharma B.V.; IBSA Institut Biochimique SA
• Treatments: Nitrofurantoin

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