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临床试验/NCT07637903
NCT07637903已完成不适用

Treatment and Prevention of Catheter Related Urinary Tract Infection Use D-mannose

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年5月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1

研究概览

简要总结

Purpose of study To find out whether D-mannose use can prevent urinary tract infection in patients need long-term catheterization.

详细描述

Study Design Inclusion criteria Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year. Exclusion criteria The above patients who unwilling to join this study, patients under 18 years old, women with pregnancy or breastfeeding plans, urological interventions in the past 3 months. Withdraw criteria and rescue medication Severe allergy or side effects occur, or the patient does not want to continue taking medication at any time. Sample Size and Study Duration The estimated patient number: 120. Study duration: 3 years 3. Please specify objectives of study when collecting extra specimen from participants There will be no extra specimen. 4. Expected Endpoints of Treatment Primary outcome: symptomatic UTI episode. Secondary outcome: non-symptomatic UTI, positive urine culture, catheter obstruction, patient report satisfaction

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients visit the Urology clinic in Tzu Chi hospital due to long-term catheterization monthly and diagnosed as recurrent UTI last year.

排除标准

  • The above patients who unwilling to join this study, patients under 18 years old, women with pregnancy or breastfeeding plans, urological interventions in the past 3 months.

研究组 & 干预措施

Standard Care followed by D-mannose

Active Comparator

Participants receive standard catheter care for the first year. After one year, participants receive D-mannose (one tablet, twice daily) for the second year. Follow-up and urine specimen collection occur monthly during scheduled outpatient catheter replacements.

干预措施: D-mannose (Dietary Supplement)

D-mannose followed by Standard Care

Experimental

Participants receive D-mannose (one tablet, twice daily) for the first year. After one year, D-mannose is suspended, and participants receive standard catheter care for the second year. Follow-up and urine specimen collection occur monthly during scheduled outpatient catheter replacements.

干预措施: D-mannose (Dietary Supplement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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