Actively Recruiting
Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-19
50
Participants Needed
2
Research Sites
52 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
Researchers are evaluating a non-antimicrobial alternative treatment for women with recurrent urinary tract infections (rUTI). The study aims to find out if intravesical instillation with hyaluronic acid and chondroitin sulphate (HA-CS) reduces the rate of symptomatic UTIs requiring antimicrobial treatment within 12 months, compared to a placebo instillation. This research addresses rising antimicrobial resistance linked to frequent use of antibiotics in urinary infections. Participants will be randomly assigned to receive either 50 ml of a sterile HA-CS solution or 50 ml of sterile purified water. The treatment is given weekly for four weeks, then every two weeks in the second month, followed by one more instillation four weeks later. Both groups receive the instillations under a triple-blinded, randomized controlled setup to ensure unbiased results. During the study, participants will attend regular visits for treatment and follow-up over 12 months. Researchers will assess the number of symptomatic UTIs, measure bacteriuria, record symptoms using the Acute Cystitis Symptom Score, and monitor time to UTI recurrence. Additional evaluations include urine cultures for resistant bacteria, antibiotic use, pain and urinary symptom scales, and quality of life assessments. Safety and effectiveness will be closely monitored throughout the study period.
CONDITIONS
Brief Title
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 70 years
- Documented history of recurrent urinary tract infections with at least 3 episodes in the last year confirmed by urine culture with 103 cfu/ml of pathogen and clinical symptoms, OR 2 episodes in the last 6 months
- Ability to give informed consent
You will not qualify if you...
- No informed consent given
- Current urinary tract infection within 7 days before randomisation
- Ongoing antimicrobial prophylaxis or immunoactive prophylaxis
- Underlying urogenital abnormalities such as significant post void residual volume (>50 ml), urethral stricture, diverticula, urinary stone, reflux, urinary neoplasia
- Presence of urological devices like catheter or ureteral stent
- Symptomatic pelvic floor disorders including genital prolapse stage 6 II
- Renal insufficiency, diabetes mellitus, or corticosteroid use
- Urogenital or gynecological surgery within 6 weeks
- Known allergy to the study medication
- Use of spermicides or intrauterine device
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive weekly intravesical instillations for four weeks, then every second week in the second month, and one additional instillation four weeks later.
7 instillation visits (in-person) over 12 weeks
Duration - Up to 12 months
Participants are monitored for recurrence of urinary tract infections and other health outcomes after treatment ends.
3 follow-up visits at 6, 9, and 12 months (in-person)
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
H
Hans-Helge Seifert, Prof. Dr. MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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