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| ID | Type | Description | Link |
|---|---|---|---|
| NL76892.091.21 | Other Identifier | algemeen beoordelings- en registratie |
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| Name | Class |
|---|---|
| IBSA Institut Biochimique SA | INDUSTRY |
| Goodlife Pharma B.V. | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | 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. |
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| Group B | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of urinary tract infections | Number of urinary tract infections per patient-year | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first urinary tract infection | Time to first urinary tract infection | 13 months |
| Global Assessment of Improvement | Changes on Global Assessment of Improvement, Likert scale: -3 (worst) to +3(best) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dick Janssen, MD, PhD | Contact | +31 6 41856516 | dick.janssen@radboudumc.nl | |
| Cléo Baars, MD | Contact | +31 6 15400527 | cleo.baars@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Dick Janssen, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
only anonymous patient data will be shared
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Cross-over randomized controlled trial. Study is set-up as non-inferiority, parallel group trial, with a 1:1 randomization.
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| Nitrofurantoin | Drug | nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily) |
|
| 7 weeks, 3 months, 6 months after start of each therapy |
| Antibiotics resistance | Difference in acquired AB resistance (increase in resistance to different antibiotic treatments) between both patients groups | Baseline, 6 months after start of each therapy |
| Cost-effectiveness: medical consumption questionnaire | Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'medical consumption questionnaire' | Baseline, 6 months after start of each therapy |
| Cost-effectiveness: productivity cost questionnaire | Difference in cost-effectiveness between the 2 therapies. This is assessed with the 'productivity cost questionnaire' | Baseline, 6 months after start of each therapy |
| Therapy specific patient reported outcomes (symptoms & bother) | Differences in therapy specific patient reported outcomes between both patient groups (measured in Therapy Specific Patient Reported Outcome (PRO) Questionnaire on Symptom & Bother rUTI & GAG therapy) | 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) | Is there a difference in the Quality-of-life between the 2 therapies during follow-up using ED-5D 5L questionnaire | baseline, 7 weeks, 3 months, 6 months after start of each therapy |
| Rijnstate ziekenhuis | Recruiting | Arnhem | Netherlands |
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| Canisius wilhelmina ziekenhuis | Recruiting | Nijmegen | Netherlands |
|
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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