Status:
RECRUITING
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
IBSA Institut Biochimique SA
Conditions:
Urinary Tract Infections
Urinary Tract Infection (UTI)
Eligibility:
FEMALE
18-70 years
Phase:
PHASE4
Brief 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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04095572
Start Date
October 27 2020
End Date
June 1 2026
Last Update
February 19 2025
Active Locations (2)
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1
Department of Gynecology, University Hospital Basel
Basel, Switzerland, 4031
2
Department of Urology, University Hospital Basel
Basel, Switzerland, 4031