Non-antimicrobial Alternative in Prophylaxis of Recurrent Urinary Tract Infections: a Prospective, Randomised-controlled, Double-blinded, Multicentre Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
intervention group A
50 ml of a sterile sodium HA (800 mg)- CS (1g) solution (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi, Italy) weekly for four weeks, then every second week in the second month and four weeks later
干预措施: intravesical instillation with HA-CS (Drug)
control group B
50 ml sterile purified water weekly for four weeks, then every second week in the second month and four weeks later
干预措施: intravesical instillation of sterile purified water (Drug)
结局指标
主要结局
Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials
时间窗: within 12 months after randomisation
Rate of symptomatic UTIs (based on clinical diagnosis) needing treatment with antimicrobials (cumulative number)
次要结局
- Change in Pelvic Pain and Urinary/Frequency (PUF) Symptom Scale(prior to randomisation and at 1 month, 3 months, 6 months, 9 months, 12 months)
- Asymptomatic bacteriuria of ≥105 cfu/ml(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)
- Time to UTI recurrence (as days between randomisation and the first recurring UTI)(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))
- Change in QoL Short Form (SF)-36 score(prior to randomisation and at 12 months)
- Symptomatic UTI (based on clinical diagnosis supported by measured bacteriuria of ≥103 cfu/ml) treated with antimicrobials(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)(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))
- Detection of multidrug-resistant bacteria in urine culture (3Multiresistant gram negatives (MRGN), 4MRGN)(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)(from randomisation to 12 months)