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โ† Trials
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Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

RecruitingPhase 4Ages 18 Years - 70 YearsFemaleUniversity Hospital, Basel, Switzerland
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Documented history of rUTI, defined as โ‰ฅ 3 episodes of (un)complicated UTI documented by urine culture with the isolation of โ‰ฅ103 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 โ‰ฅ 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
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What it tests

  • intravesical instillation with HA-CS
  • intravesical instillation of sterile purified water
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Where

2 sites
Department of Gynecology, University Hospital Basel
Basel, Switzerland
Department of Urology, University Hospital Basel
Basel, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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