Using hyaluronic acid and chondroitin sulfate to prevent recurrent urinary tract infections in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of intravesical instillation of hyaluronic acid (HA) and chondroitin sulfate (CS) in reducing the incidence of symptomatic urinary tract infections (UTIs) in women with a history of recurrent UTIs. Participants will be randomly assigned to receive either the HA-CS treatment or a placebo, with the primary outcome being the rate of UTIs requiring antimicrobial treatment within 12 months. The study aims to address the growing issue of antimicrobial resistance by exploring a non-antibiotic prophylactic approach. The trial is conducted at the University Hospital Basel, focusing on patients with documented recurrent UTIs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* No informed consent
* Concomitant UTI (\< 7 days prior to randomisation)
* Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason like endocarditis, transplanted patients under immunosuppression)
* Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)
* Documented underlying urogenital abnormality (e.g. significant post voiding residual volume (\>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux, urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic pelvic floor disorder (e.g. genital prolapse stage ≥ II)
* Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use)
* Urogenital urological or gynecological surgery \< 6 weeks
* Known allergy to the study medication
* Use of spermicides or intrauterine device
* Pregnancy

Where it's running

• Department of Gynecology, University Hospital Basel
  Basel, Switzerland Recruiting
• Department of Urology, University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Kathrin Bausch, Dr. med — Department of Urology, University Hospital Basel
• Study coordinator: Kathrin Bausch, Dr. med
• Email: kathrin.bausch@usb.ch
• Phone: +41 61 265 72 80

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.