Actively Recruiting
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Led by Radboud University Medical Center · Updated on 2024-11-18
100
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
I
IBSA Institut Biochimique SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of hyaluronic acid-chondroitin sulphate (HA-CS) bladder installations compared to the standard antibiotic treatment with nitrofurantoin in preventing recurrent urinary tract infections (rUTI) in adult women. This study is a randomized, non-inferiority, parallel group crossover trial involving female participants over 18 years who have experienced at least three symptomatic UTIs in the past year without adequate curable options. Participants receive two treatments consecutively: 50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks followed by monthly maintenance for 6 months, and oral nitrofurantoin 100mg daily (or trimethoprim if nitrofurantoin is not suitable) for 6 months. The order of treatments is randomized, with a 4-week washout period between therapies. A total of 100 women are enrolled in the study. During the study, participants complete questionnaires about symptoms, quality of life, and healthcare usage. Urine samples are collected at set times to monitor infections and antibiotic resistance. The main measure is the number of UTIs per patient per year. Secondary measures include time to first UTI, global response assessment, antibiotic resistance patterns, cost-effectiveness, patient-reported outcomes, and general quality of life. The study duration covers 13 months of monitoring per participant.
CONDITIONS
Brief Title
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients over 18 years old
- At least 3 symptomatic urinary tract infections in the previous year
- At least one UTI confirmed by positive culture and antibiogram
- Other UTIs confirmed by urine sediment with positive nitrite or positive culture
- No adequate curable therapeutic options such as bladder stones
You will not qualify if you...
- Male
- Under 18 years old
- Pregnant
- Already receiving GAG therapy
- Currently on prophylactic antibiotics
- Started or stopped cranberry, d-mannose therapy, or vaginal estrogenic cream in the last two months
- Received gentamicin or other antibiotic instillations in the previous 2 months
- Allergic to more than 3 commonly used antibiotics in Dutch guidelines
- Presence of urinary fistula or urinary stones
- Urogenital cancer
- Bladder Pain Syndrome or Interstitial Cystitis
- Chronic pelvic pain
- Untreated or recently treated sexually transmitted disease within 2 months
- Urinary diversion
- Indwelling or suprapubic catheter
- Performing self-catheterization more than once per day
- Post-void residual volume over 200ml
- Unable to give informed consent
- Recurrent urosepsis
- Multiresistant bacteria in previous urine cultures
- Contraindications to nitrofurantoin or trimethoprim due to kidney, liver, lung, blood, or neurological conditions
- Severe lung or respiratory dysfunction
- Does not tolerate catheterization
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 - 6 months for each therapy
Participants receive weekly bladder instillations of sterile Ialuril for 6 weeks, followed by monthly maintenance therapy for 6 months, or take oral nitrofurantoin daily for 6 months. The order of treatments is randomized and participants receive both treatments consecutively with a 4-week wash-out period in between.
Weekly visits for 6 weeks, then monthly visits for 6 months; or daily oral medication for 6 months
Duration - 4 weeks
Participants undergo a 4-week wash-out period without treatment between the two therapy phases.
No visits specified
Duration - 6 months for each therapy
Participants receive the alternate therapy (either Ialuril bladder instillations or oral nitrofurantoin daily) for 6 months following the wash-out period.
Weekly visits for 6 weeks, then monthly visits for 6 months; or daily oral medication for 6 months
Trial Site Locations
Total: 3 locations
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
2
Rijnstate ziekenhuis
Arnhem, Netherlands
Actively Recruiting
3
Canisius wilhelmina ziekenhuis
Nijmegen, Netherlands
Actively Recruiting
Research Team
D
Dick Janssen, MD, PhD
C
Cléo Baars, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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