drugset / Trial / NCT04095572

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

NCT04095572

RandomizedParallel-groupTriple-blindTreatment

Summary

Urological pathogens are effected by rising antimicrobial resistance rates due to the frequent use of antimicrobials for treatment and prophylaxis. Intravesical instillation with hyaluronic acid (HA) and chondroitin sulphate (CS) obtained positive outcomes in the treatment of overactive bladder, radiation cystitis and interstitial cystitis by replenishment of the glycosaminoglycan layer of the bladder. This study is to investigate whether intravesical instillation with HA-CS in patients with recurrent urinary tract infections (rUTI) is superior to a placebo instillation in terms of reduction of rate of symptomatic urinary tract infections (UTIs) (based on clinical diagnosis) needing treatment with antimicrobials within 12 months after randomisation.

Timeline

Start
2020-10-27
Primary completion
2025-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chondroitin sulphate Unknown 1 g Other
Comparator Hyaluronic Acid Other / unclassified 800 mg Other