Comparing GAG therapy to antibiotics for preventing recurrent urinary tract infections
Official title: Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Run by Radboud University Medical Center · NCT05652374 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 3 sites (Nijmegen, Gelderland and 2 other locations) |
| Status | Recruiting |
| Started | October 20, 2022 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 18, 2024 |
| Trial ID | NCT05652374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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D-mannose to prevent recurrent urinary tract infections in post-menopausal women.
This trial will test whether taking 2 g of D-mannose daily prevents recurrent urinary tract infections in post‑menopausal women.
-
Using fecal microbiota transplantation to prevent recurrent urinary tract infections
This study is testing if a treatment using gut bacteria from healthy donors can help women who often get urinary tract infections to have fewer of them.
-
Effect of ASTARTE™ Probiotic on Recurrent Urinary Tract Infections
This study is testing if a special probiotic can help women aged 18-40 who keep getting urinary tract infections feel better and have fewer symptoms.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.