Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Number of urinary tract infections
Study Overview
Brief Summary
The GT RACING is a study comparing the efficacy of HA-CS bladder installations with prophylactic antibiotics in the prevention of recurrent urinary tract infections (rUTI).
Detailed Description
The main objective of the study is to compare efficacy between hyaluronic acid - chondroitin sulphate (HA-CS) treatment and gold standard treatment (AB prophylaxis). Study is set-up as non-inferiority, parallel group cross-over RCT, with a 1:1 randomization.
Study population: Female (>18rs) with at least 3 symptomatic urinary tract infections (UTI's) in the previous year with no adequate curable therapeutic options.
Intervention: 50ml of sterile Ialuril (HA 1.6% CS 2%) weekly for 6 weeks, followed by monthly maintenance therapy for 6 months.
Control : oral nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily will be given.
All patients recieve both treatments (ialuril and nitrofurantoin) consecutively, for 6 months each. The order of the therapies is determined by randomisation. Between therapies there is a 4 weeks 'wash-out' period. A total of 100 patients will be included.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult female patients (>18 years) who had at least 3 symptomatic UTI's in the previous year with no adequate curable therapeutic options (e.g. bladder stones)
- •At least one UTI's must be confirmed with a positive culture and antibiogram, further UTI's must be confirmed with a urine sediment with positive nitrite or a positive culture.
Exclusion Criteria
- •< 18 years
- •Already on GAG therapy
- •Already on prophylactic antibiotics
- •Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in the last two months
- •Had Gentamicin or other antibiotic instillations in the previous 2 months
- •Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin, trimethoprim, Fosfomycin)
- •A urinary fistula
- •Urinary stones
- •Urogenital cancer
- •Bladder Pain Syndrome - Interstitial Cystitis
- •Chronic pelvic pain
- •Had a STD untreated or treated in the previous 2 months
- •A urinary diversion
- •An Indwelling catheter
- •A suprapubic catheter
- •Performing >1/day self-catheterization
- •A residue after voiding (PVR) of >200ml
- •Unable (also legal) to give informed consent
- •Recurrent urosepsis
- •Multiresistant bacteria in previous urine cultures
- •Contra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR < 30), lung- or liver problems or neuropathy after previous use of nitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesium trisilicate.
- •Contra-indications and interactions for trimethoprim: severe kidney or liver dysfunction, blood count abnormality, use of vitamin K antagonists, use of folic acid antagonists, use of ace inhibitors
- •Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis, COPD)
- •Does not tolerate catheterization
Arms & Interventions
Group A
Ialuril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period.
Intervention: Ialuril 50ml Prefill (Device)
Group A
Ialuril therapy for 6 months followed by nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months. In between therapies there is a 4 week wash-out period.
Intervention: Nitrofurantoin (Drug)
Group B
Nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period.
Intervention: Ialuril 50ml Prefill (Device)
Group B
Nitrofuranoïne (or trimethoprim) prophylactic therapy for 6 months followed by Ialuril therapy for 6 months. In between therapies there is a 4 week wash-out period.
Intervention: Nitrofurantoin (Drug)
Outcomes
Primary Outcomes
Number of urinary tract infections
Time Frame: 13 months
Number of urinary tract infections per patient-year
Secondary Outcomes
- Time to first urinary tract infection(13 months)
- Global Assessment of Improvement(7 weeks, 3 months, 6 months after start of each therapy)
- Antibiotics resistance(Baseline, 6 months after start of each therapy)
- Cost-effectiveness: medical consumption questionnaire(Baseline, 6 months after start of each therapy)
- Cost-effectiveness: productivity cost questionnaire(Baseline, 6 months after start of each therapy)
- Therapy specific patient reported outcomes (symptoms & bother)(baseline, 7 weeks, 3 months, 6 months after start of each therapy)
- General quality of life questionnaire (mobility, self-care, daily activities, pain/discomfort, anxiety/depression)(baseline, 7 weeks, 3 months, 6 months after start of each therapy)