Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Официальное название

Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study

Обзор

Urological pathogens are effected by rising antimicrobial resistance rates due to the frequent use of antimicrobials for treatment and prophylaxis. Intravesical instillation with hyaluronic acid (HA) and chondroitin sulphate (CS) obtained positive outcomes in the treatment of overactive bladder, radiation cystitis and interstitial cystitis by replenishment of the glycosaminoglycan layer of the bladder. This study is to investigate whether intravesical instillation with HA-CS in patients with recurrent urinary tract infections (rUTI) is superior to a placebo instillation in terms of reduction of rate of symptomatic urinary tract infections (UTIs) (based on clinical diagnosis) needing treatment with antimicrobials within 12 months after randomisation.

Вмешательства

• Препарат intravesical instillation with HA-CS
  intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)
• Препарат intravesical instillation of sterile purified water
  intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)

Первичные конечные точки

• Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials [Срок оценки: within 12 months after randomisation]

Вторичные конечные точки (8)

• Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials [Срок оценки: at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)]
• Symptoms of UTI according to the Acute Cystitis Symptom Score (ACSS) (cumulative number of each symptom) [Срок оценки: at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)]
• Time to UTI recurrence (as days between randomisation and the first recurring UTI) [Срок оценки: at screening and at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)]
• Asymptomatic bacteriuria of ≥105 cfu/ml [Срок оценки: at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8) if the urine dipstick is suspicious, at the 7th instillation (= week 12 )and at 12 month follow-up]
• Detection of multidrug-resistant bacteria in urine culture (3Multiresistant gram negatives (MRGN), 4MRGN) [Срок оценки: at screening and at at each instillation visit (week 1 = Randomization, week 2, week 3, week 4, week 6, week 8, week 12) and at follow-up visits after randomization (month 6, month 9, month 12)]
• Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) [Срок оценки: from randomisation to 12 months]
• Change in Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale [Срок оценки: prior to randomisation and at 1 month, 3 months, 6 months, 9 months, 12 months]
• Change in QoL Short Form (SF)-36 score [Срок оценки: prior to randomisation and at 12 months]

Критерии участия

Критерии включения

• Documented history of rUTI, defined as ≥ 3 episodes of (un)complicated UTI documented by urine culture with the isolation of ≥103 cfu/ml of an identified pathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month

Критерии исключения

• No informed consent
• Concomitant UTI (< 7 days prior to randomisation)
• Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason like endocarditis, transplanted patients under immunosuppression)
• Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)
• Documented underlying urogenital abnormality (e.g. significant post voiding residual volume (>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux, urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic pelvic floor disorder (e.g. genital prolapse stage ≥ II)
• Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use)
• Urogenital urological or gynecological surgery < 6 weeks
• Known allergy to the study medication
• Use of spermicides or intrauterine device
• Pregnancy

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• Department of Gynecology, University Hospital Basel — Basel
• Department of Urology, University Hospital Basel — Basel

Идентификаторы

NCT: NCT04095572 · 2019-01377; me19Bausch

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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