Phase
Condition
Urinary Tract Infections
Treatment
Ialuril 50ml Prefill
Nitrofurantoin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult female patients (>18 years) who had at least 3 symptomatic UTI's in theprevious 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 apositive culture.
Exclusion
Exclusion Criteria:
Male
< 18 years
Pregnant
Already on GAG therapy
Already on prophylactic antibiotics
Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in thelast 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 ofnitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesiumtrisilicate.
Contra-indications and interactions for trimethoprim: severe kidney or liverdysfunction, blood count abnormality, use of vitamin K antagonists, use of folicacid antagonists, use of ace inhibitors
Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis,COPD)
Does not tolerate catheterization
Study Design
Study Description
Connect with a study center
Radboudumc
Nijmegen, Gelderland 6525 GA
NetherlandsActive - Recruiting
Rijnstate ziekenhuis
Arnhem,
NetherlandsActive - Recruiting
Canisius wilhelmina ziekenhuis
Nijmegen,
NetherlandsActive - Recruiting
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