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Phase 4
Age: 18Years - 70Years
FEMALE
ID04095572

Study of Intravesical Hyaluronic Acid and Chondroitin Sulphate to Prevent Recurrent Urinary Tract Infections in Women Aged 18 to 70

Led by University Hospital, Basel, Switzerland · Updated on 2025-02-19

50

Participants Needed

2

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a non-antimicrobial alternative treatment for women with recurrent urinary tract infections rUTI. The study aims to find out if intravesical instillation with hyaluronic acid and chondroitin sulphate HA-CS reduces the rate of symptomatic UTIs requiring antimicrobial treatment within 12 months, compared to a placebo instillation. This research addresses rising antimicrobial resistance linked to frequent use of antibiotics in urinary infections. Participants will be randomly assigned to receive either 50 ml of a sterile HA-CS solution or 50 ml of sterile purified water. The treatment is given weekly for four weeks, then every two weeks in the second month, followed by one more instillation four weeks later. Both groups receive the instillations under a triple-blinded, randomized controlled setup to ensure unbiased results. During the study, participants will attend regular visits for treatment and follow-up over 12 months. Researchers will assess the number of symptomatic UTIs, measure bacteriuria, record symptoms using the Acute Cystitis Symptom Score, and monitor time to UTI recurrence. Additional evaluations include urine cultures for resistant bacteria, antibiotic use, pain and urinary symptom scales, and quality of life assessments. Safety and effectiveness will be closely monitored throughout the study period.

CONDITIONS

Brief Title

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Research Team

K

Kathrin Bausch, Dr. med

H

Hans-Helge Seifert, Prof. Dr. MD

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