Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study

Last updated: November 14, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

Ialuril 50ml Prefill

Nitrofurantoin

Clinical Study ID

NCT05652374
111802
NL76892.091.21
  • Ages > 18
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult female patients (>18 years) who had at least 3 symptomatic UTI's in theprevious year with no adequate curable therapeutic options (e.g. bladder stones)

  2. 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 apositive culture.

Exclusion

Exclusion Criteria:

  1. Male

  2. < 18 years

  3. Pregnant

  4. Already on GAG therapy

  5. Already on prophylactic antibiotics

  6. Started or stopped cranberry/d-mannose therapy or vaginal estrogenic creme in thelast two months

  7. Had Gentamicin or other antibiotic instillations in the previous 2 months

  8. Allergic to >3 regular used antibiotics in Dutch guidelines (ed. Nitrofurantoin,trimethoprim, Fosfomycin)

  9. A urinary fistula

  10. Urinary stones

  11. Urogenital cancer

  12. Bladder Pain Syndrome - Interstitial Cystitis

  13. Chronic pelvic pain

  14. Had a STD untreated or treated in the previous 2 months

  15. A urinary diversion

  16. An Indwelling catheter

  17. A suprapubic catheter

  18. Performing >1/day self-catheterization

  19. A residue after voiding (PVR) of >200ml

  20. Unable (also legal) to give informed consent

  21. Recurrent urosepsis

  22. Multiresistant bacteria in previous urine cultures

  23. Contra-indications and interactions for Nitrofurantoin: severe kidney disfunction (GFR < 30), lung- or liver problems or neuropathy after previous use ofnitrofurantoin, acute porphyria, known G6PD deficiency, use of magnesiumtrisilicate.

  24. Contra-indications and interactions for trimethoprim: severe kidney or liverdysfunction, blood count abnormality, use of vitamin K antagonists, use of folicacid antagonists, use of ace inhibitors

  25. Severe lung/respiratory disfunction (reduced lung capacity, lung cancer, fibrosis,COPD)

  26. Does not tolerate catheterization

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Ialuril 50ml Prefill
Phase: 4
Study Start date:
October 20, 2022
Estimated Completion Date:
October 31, 2027

Study 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.

During the study patients will fill-out questionnaires regarding symptoms, quality of life and use of healthcare. Furthermore urine will be collected at set timepoints.

Main study parameters/endpoints: The main study parameter is the number of UTI per patient-year. Secondary parameters are time to rUTI (wks.), outcome on the global responce assessment (GRA) scale, pattern of antibiotic resistance, outcome on the patient reported outcome questionnaire, cost effectiveness and Quality-of-life.

Connect with a study center

  • Radboudumc

    Nijmegen, Gelderland 6525 GA
    Netherlands

    Active - Recruiting

  • Rijnstate ziekenhuis

    Arnhem,
    Netherlands

    Active - Recruiting

  • Canisius wilhelmina ziekenhuis

    Nijmegen,
    Netherlands

    Active - Recruiting

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