Using hyaluronic acid and chondroitin sulfate to prevent recurrent urinary tract infections in women
Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study
This study is testing whether a combination of hyaluronic acid and chondroitin sulfate can help women who often get urinary tract infections by reducing the number of infections they experience.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT04095572 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with a documented history of recurrent urinary tract infections, defined as three or more episodes in the past year.
Not a fit: Patients currently undergoing antimicrobial prophylaxis or with significant urogenital abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective non-antibiotic option for preventing recurrent urinary tract infections in women.
How similar studies have performed: While the use of HA and CS has shown positive outcomes in other bladder conditions, this specific approach for recurrent UTIs is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.