NCT04095572 Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
| NCT ID | NCT04095572 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Urinary Tract Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-10-27 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2020-10-27 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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 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
Contact & Investigator
Kathrin Bausch, Dr. med
PRINCIPAL INVESTIGATOR
Department of Urology, University Hospital Basel
Frequently Asked Questions
Who can join the NCT04095572 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04095572 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04095572 currently recruiting?
Yes, NCT04095572 is actively recruiting participants. Contact the research team at kathrin.bausch@usb.ch for enrollment information.
Where is the NCT04095572 trial being conducted?
This trial is being conducted at Basel, Switzerland, Basel, Switzerland.
Who is sponsoring the NCT04095572 clinical trial?
NCT04095572 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Kathrin Bausch, Dr. med at Department of Urology, University Hospital Basel. The trial plans to enroll 50 participants.