Comparing GAG therapy to antibiotics for preventing recurrent urinary tract infections
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
This study is testing whether a new bladder treatment using hyaluronic acid and chondroitin sulfate can help women with recurrent urinary tract infections just as well as antibiotics.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 3 sites (Nijmegen, Gelderland and 2 other locations) |
| Trial ID | NCT05652374 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of hyaluronic acid-chondroitin sulfate (HA-CS) bladder installations compared to the standard antibiotic treatment for preventing recurrent urinary tract infections (rUTI) in women. It is designed as a non-inferiority, parallel group crossover randomized controlled trial, where participants will receive both treatments in a randomized order over a total period of 12 months. The primary endpoint is the number of UTIs per patient-year, while secondary endpoints include quality of life assessments and patterns of antibiotic resistance. A total of 100 female patients over 18 years with a history of rUTIs will be enrolled.
Who should consider this trial
Good fit: Ideal candidates are adult females over 18 years who have experienced at least three symptomatic UTIs in the past year and have no adequate curable therapeutic options.
Not a fit: Patients who are male, under 18 years, pregnant, or have specific urinary tract conditions such as urinary stones or cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-antibiotic alternative for preventing recurrent urinary tract infections, potentially reducing antibiotic resistance.
How similar studies have performed: While the use of GAG therapy is gaining interest, this specific comparison to the gold standard antibiotic treatment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen, Gelderland and 2 other locations
- Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
- Rijnstate ziekenhuis — Arnhem, Netherlands (Recruiting)
- Canisius wilhelmina ziekenhuis — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dick Janssen, MD, PhD — Radboud University Medical Center
- Study coordinator: Dick Janssen, MD, PhD
- Email: dick.janssen@radboudumc.nl
- Phone: +31 6 41856516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.