Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Last updated: February 18, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

intravesical instillation with HA-CS

intravesical instillation of sterile purified water

Clinical Study ID

NCT04095572
2019-01377; me19Bausch
  • Ages 18-70
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented history of rUTI, defined as ≥ 3 episodes of (un)complicated UTIdocumented by urine culture with the isolation of ≥103 cfu/ml of an identifiedpathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month

Exclusion

Exclusion Criteria:

  • No informed consent

  • Concomitant UTI (< 7 days prior to randomisation)

  • Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason likeendocarditis, transplanted patients under immunosuppression)

  • Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)

  • Documented underlying urogenital abnormality (e.g. significant post voiding residualvolume (>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux,urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomaticpelvic floor disorder (e.g. genital prolapse stage ≥ II)

  • Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroiduse)

  • Urogenital urological or gynecological surgery < 6 weeks

  • Known allergy to the study medication

  • Use of spermicides or intrauterine device

  • Pregnancy

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: intravesical instillation with HA-CS
Phase: 4
Study Start date:
October 27, 2020
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Department of Gynecology, University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Department of Urology, University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

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