Efficacy and Safety of Urine Alkalinization in Treatment of Uncomplicated Urinary Tract Infection in Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin
研究概览
简要总结
The goal of this clinical trial is to evaluate whether urinary alkalinization using potassium citrate can relieve symptoms and improve urine culture results in women aged 18 to 50 years with uncomplicated urinary tract infections (UTIs). The main questions it aims to answer are:
Does urinary alkalinization reduce UTI symptom scores by Day 7?
Does it lead to better urine culture results compared to antibiotic?
Researchers will compare urinary alkalinization with potassium citrate to antibiotic to see if it provides more symptom relief and better microbiological outcomes.
Participants will:
Take either potassium citrate or antibiotic
Be assessed for symptoms and adverse events on Day 7
Provide a urine sample for culture before and after treatment
Report any return visits due to worsening symptoms or medication side effects
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 and ≤
- •Symptoms of uncomplicated UTI or cystitis; including urinary frequency, urgency and dysuria.
- •Positive urine culture of mid-urine urine.
排除标准
- •Post menopausal women.
- •Pregnancy.
- •Complicated UTIs, such as those requiring hospital admission, infections associated with fevers, those with urinary tract abnormalities, urinary tract calculi or urinary tract obstruction.
- •History of recurrent UTI.
- •Recent antibiotic use.
- •Acute pyelonephritis.
- •Immunocompromising conditions.
- •Chronic conditions such as interstitial cystitis, painful bladder syndrome, chronic pelvic pain syndrome.
- •Patients with CKD.
- •Patients with allergy to potassium citrate.
研究组 & 干预措施
Potassium Citrate Treatment for UTI Symptom Relief
Participants in this arm will receive potassium citrate oral sachets twice daily for 7 days. The aim is to assess the effectiveness of potassium citrate in alleviating UTI symptoms such as dysuria and urgency in women with uncomplicated urinary tract infections. Participants will be monitored for symptom improvement, side effects, and any changes in urine culture.
干预措施: potassium citrate (Drug)
Nitrofurantoin Antibiotic Treatment for UTI
Participants in this group will receive the antibiotic "Nitrofurantoin" for 7 days. This group serves as a control to compare the effectiveness of antibiotics against urinary alkalinization in treating symptoms of uncomplicated urinary tract infections (UTIs). The primary outcomes include symptom relief, changes in urine culture, and the occurrence of any side effects. This group's results will be compared with Arm 1 to determine if urinary alkalinization is equally or more effective than antibiotics in managing UTI symptoms.
干预措施: Nitrofurantoin (Drug)
结局指标
主要结局
Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin
时间窗: 7 days (Participants will be assessed at baseline, day 3, and day 7).
The primary outcome of this study is the reduction in urinary tract infection (UTI) symptoms, specifically dysuria (painful urination), urgency, and frequency, after 7 days of treatment with either Potassium Citrate or Nitrofurantoin. The severity of these symptoms will be measured using a standardized symptom questionnaire, where participants will rate the intensity of their symptoms at baseline (pre-treatment), day 3, and day 7. A reduction of ≥50% in symptom severity will be considered clinically significant. The results will be compared between the Potassium Citrate and Nitrofurantoin groups to determine which treatment is more effective in relieving UTI symptoms.
次要结局
未报告次要终点
研究者
Amr Esam Saad Mohamed Darwish
Lecturer
Assiut University