Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Sep 17, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for women who frequently suffer from urinary tract infections (UTIs). The study will test whether a special solution made of hyaluronic acid and chondroitin sulfate, which has shown promise in treating other bladder conditions, can help reduce the number of symptomatic UTIs compared to a placebo (a treatment that has no active ingredients). Researchers will follow participants for 12 months to see if this treatment lowers the need for antibiotic medications.

To be eligible for this trial, participants must be women aged between 18 and 90 who have a history of recurrent UTIs—defined as having three or more infections in the last year or two infections in the last six months confirmed by urine tests. Participants will receive either the treatment or a placebo and will be monitored for any changes in their UTI symptoms. It's important to know that women with certain health conditions or those currently taking specific medications may not be able to participate. If you're interested in learning more or possibly joining the study, it's a good idea to discuss it with your healthcare provider.

Gender

FEMALE

Eligibility 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