RecruitingPhase 4NCT05652374
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Sponsor
Radboud University Medical Center
Enrollment
100 participants
Start Date
Oct 20, 2022
Study Type
INTERVENTIONAL
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).
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria2
- 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)
- 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 Criteria26
- Male
- < 18 years
- Pregnant
- Already on GAG therapy
- Already on prophylactic antibiotics
- Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months
- Had Gentamicin or other antibiotic instillations in the previous 2 months
- Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)
- A urinary fistula
- Urinary stones
- Urogenital cancer
- Bladder Pain Syndrome - Interstitial Cystitis
- Chronic pelvic pain
- Had a STD untreated or treated in the previous 2 months
- A urinary diversion
- An Indwelling catheter
- A suprapubic catheter
- Performing >1/day self-catheterization
- A residue after voiding (PVR) of >200ml
- Unable (also legal) to give informed consent
- Recurrent urosepsis
- Multiresistant bacteria in previous urine cultures
- 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.
- 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
- Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)
- Does not tolerate catheterization
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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)
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05652374