Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study
Who is this study for? Adult female patients with Urinary Tract Infection
What treatments are being studied? Hyaluronic Acid
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Documented history of rUTI, defined as ≥ 3 episodes of (un)complicated UTI documented by urine culture with the isolation of ≥103 cfu/ml of an identified pathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month
Locations
Other Locations
Switzerland
Department of Gynecology, University Hospital Basel
RECRUITING
Basel
Department of Urology, University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Kathrin Bausch, Dr. med
kathrin.bausch@usb.ch
+41 61 265 72 80
Backup
Hans-Helge Seifert, Prof. Dr. MD
helge.seifert@usb.ch
+41 61 265 72 80
Time Frame
Start Date:2020-10-27
Estimated Completion Date:2026-06
Participants
Target number of participants:50
Treatments
Active_comparator: intervention group A
50 ml of a sterile sodium HA (800 mg)- CS (1g) solution (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy) weekly for four weeks, then every second week in the second month and four weeks later
Placebo_comparator: control group B
50 ml sterile purified water weekly for four weeks, then every second week in the second month and four weeks later