Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 4INTERVENTIONAL

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - No willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

intravesical instillation with HA-CS

intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)

DRUG

intravesical instillation of sterile purified water

intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)

Locations (2)

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