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RECRUITING
NCT04095572
PHASE4

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2020-10-27

Completion Date

2026-06

Last Updated

2025-02-19

Healthy Volunteers

No

Interventions

DRUG

intravesical instillation with HA-CS

intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)

DRUG

intravesical instillation of sterile purified water

intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)

Locations (2)

Department of Gynecology, University Hospital Basel

Basel, Switzerland

Department of Urology, University Hospital Basel

Basel, Switzerland