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临床试验/NCT01808755
NCT01808755已完成3 期

Recurrent Urinary Tract Infections in Adult Women: a Pilot Study With Oral D Mannose

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Days

研究概览

简要总结

Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic regimes do not change the long term risk of recurrence.

Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.

Design, setting and participants- : In this crossover trial female patient were eligible for the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12 months. Suitable patients were randomly assigned to antibiotic treatment with trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received the other intervention in the second phase of the study.

Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and number of voidings between treatment. Data analysis was performed with STATA statistical package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).

详细描述

INTRODUCTION Urinary tract infections (UTIs) are among the most common infectious diseases, with a substantial financial burden to society. In Europe data on the presence of various types of UTIs indicate a high impact on quality of life of people affected, it is important the impact of urinary tract infections on the economy in general and on the health system in particular. In the U.S. urinary tract infections account for more than 7 million doctor visits each year, including more than 2 million visits for cystitis. The bacterium E. coli, which is the source of 90% of urinary tract infections, shows an incredible ability to survive in the human body, and is able to change rapidly to survive antibiotics. An infection of the urinary tract must be stopped before it begins to migrate to the kidneys, where it can cause serious infections. Women with frequent reinfections have a rate of 0.13 to 0.22 UTIs per month (1.6 to 2.6 infections per year). For premenopausal, healthy, and active females, recurrent UTIs are a major healthcare concern. Recurrent urinary tract infection (RUTI) is defined as three episodes of urinary tract infection (UTI) with 3 positive urine cultures in the previous 12 months or two episodes in the last six months. The usual present strategies employing a prophylactic antibiotic regime to prevent recurrent UTIs include long-term low-dose prophylactic antimicrobial treatment or postcoital antibiotic treatment. However, it seems that these strategies do not alter the long-term risk of recurrence. Patients with frequent UTIs who take prophylactic antimicrobial agents for extended periods decrease their infections during prophylaxis, but the rate of infection returns to pre-treatment rates when prophylaxis is stopped . Long-term antibiotics do not appear to positively affect the patient's basic susceptibility to infections. The cell wall of E. coli bacteria has tiny finger-like projections that contain complex molecules called lectins on their surface. These lectins act as a cellular glue that binds the bacteria to the bladder wall so they cannot be easily rinsed out by urination . In this pilot study the aim was to evaluate if oral D Mannose could be used as a safe and effective treatment and as a prophylactic measure for recurrent UTIs in adult women.

PATIENTS AND METHODS Suitable female patients with recurrent urinary tract infections who were visited at the outpatient Clinic of our Urology Department were eligible for study. The work has been conducted in accordance with the principles of the Declaration of Helsinki of World Medical Association. Patients were enrolled in the study after treatment for the most recent urinary tract infection if they had positive urinary cultures at that time.

Each participant entering the trial was assigned to one of the following treatments in a random sequence:

  1. A regimen of five-day antibiotic therapy with trimethoprim/sulfamethoxazole 160 mg/800 mg twice a day. Then 1 week of antibiotic every 4 weeks for the following 23 weeks
  2. A regimen of oral D Mannose 1 gr. 3 times a day, every 8 hours for 2 weeks, and subsequently 1 gr. twice a day for 22 weeks. D-Mannose has the best activity when urine has neutral pH, therefore patients were instructed to measure urinary pH using dipsticks and use oral sodium bicarbonate 250 mg b.i.d.or potassium citrate 1 gr. b.i.d. as alkalinizing agents if pH was <7.

Patients were randomly assigned to antibiotic treatment with trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received the other intervention in the second phase of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients 18 years old or older
  • 3 or more culture documented urinary tract infections in the preceding 12 months
  • Patients who had not taken antimicrobials within 4 weeks and were not pregnant or contemplating pregnancy.

排除标准

  • Patients with evidence of upper urinary tract infection, such as temperature higher than 38 °C, flank/lumbar pain or tenderness.

研究组 & 干预措施

D Mannose

Experimental

1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks

干预措施: D Mannose (Dietary Supplement)

D Mannose

Experimental

1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks

干预措施: trimethoprim/sulfamethoxazole (Drug)

trimethoprim/sulfamethoxazole

Active Comparator

intervention was a 5-days course of trimethoprim/sulfamethoxazole cp 160 mg/800 mg twice a day. Then one week of antibiotic every 4 weeks for the following 23 weeks

干预措施: D Mannose (Dietary Supplement)

trimethoprim/sulfamethoxazole

Active Comparator

intervention was a 5-days course of trimethoprim/sulfamethoxazole cp 160 mg/800 mg twice a day. Then one week of antibiotic every 4 weeks for the following 23 weeks

干预措施: trimethoprim/sulfamethoxazole (Drug)

结局指标

主要结局

Days

时间窗: 168

time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniele Porru

Consultant Urologist, Principal investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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