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

ConditionRecurrent Urinary Tract Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRadboud University Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Male

< 18 years

Pregnant

Already on GAG therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ialuril 50ml Prefill

    Device

    50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months

  • Nitrofurantoin

    Drug

    nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group AOther 2 interventions
Group B: Group BOther 2 interventions

Trial outcomes

Primary outcomes

1

Number of urinary tract infections

Number of urinary tract infections per patient-year

Time frame
13 months

Secondary outcomes

1

Time to first urinary tract infection

Time to first urinary tract infection

Time frame
13 months
2

Global Assessment of Improvement

Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best)

Time frame
7 weeks, 3 months, 6 months after start of each therapy
3

Antibiotics resistance

Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups

Time frame
Baseline, 6 months after start of each therapy
4

Cost-effectiveness: medical consumption questionnaire

Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire'

Time frame
Baseline, 6 months after start of each therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

IBSA Institut Biochimique SA

Collaborator

Goodlife Pharma B.V.

Collaborator

Source ClinicalTrials.gov
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