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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство Ialuril 50ml Prefill
  50ml of sterile Ialuril (HA 1.6% CS 2%) bladder instillations weekly for 6 weeks, followed by monthly maintenance therapy for 6 months
• Препарат Nitrofurantoin
  nitrofurantoin 100mg daily (1dd100mg or 2dd50mg) for 6 months. ( In case of resistance/intolerance/allergy for nitrofurantoin alternatively trimethoprim 100mg daily)

Первичные конечные точки

• Number of urinary tract infections [Срок оценки: 13 months]

Вторичные конечные точки (7)

• Time to first urinary tract infection [Срок оценки: 13 months]
• Global Assessment of Improvement [Срок оценки: 7 weeks, 3 months, 6 months after start of each therapy]
• Antibiotics resistance [Срок оценки: Baseline, 6 months after start of each therapy]
• Cost-effectiveness: medical consumption questionnaire [Срок оценки: Baseline, 6 months after start of each therapy]
• Cost-effectiveness: productivity cost questionnaire [Срок оценки: Baseline, 6 months after start of each therapy]
• Therapy specific patient reported outcomes (symptoms & bother) [Срок оценки: 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) [Срок оценки: baseline, 7 weeks, 3 months, 6 months after start of each therapy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Male
• < 18 years
• Pregnant
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Нидерланды · 3 центра

• Radboudumc — Nijmegen
• Rijnstate ziekenhuis — Arnhem
• Canisius wilhelmina ziekenhuis — Nijmegen

Идентификаторы

NCT: NCT05652374 · 111802 · NL76892.091.21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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