Actively Recruiting
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-19
50
Participants Needed
2
Research Sites
291 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
I
IBSA Institut Biochimique SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years
- History of recurrent urinary tract infections defined as 3 or more episodes with positive urine cultures in the past year or 2 or more episodes in the last 6 months
- Clinical symptoms present during documented infections
You will not qualify if you...
- No informed consent given
- Current urinary tract infection within 7 days before randomization
- Ongoing antimicrobial prophylaxis for any reason
- Current use of other prophylactic strategies such as immunoactive prophylaxis
- Known urogenital abnormalities like significant post-void residual volume over 50 ml, urethral stricture, diverticula, urinary stones, reflux, or neoplasia
- Presence of urological devices such as catheters or stents
- Symptomatic pelvic floor disorders including genital prolapse stage II or higher
- Concomitant diseases such as renal insufficiency, diabetes mellitus, or corticosteroid use
- Urological or gynecological surgery within 6 weeks prior to study
- Known allergy to study medications
- Use of spermicides or intrauterine devices
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Gynecology, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
2
Department of Urology, University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
K
Kathrin Bausch, Dr. med
CONTACT
H
Hans-Helge Seifert, Prof. Dr. MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here