Urine Alkalinization for UTI in Women: RCT

Not Applicable

Not yet recruiting

• Conditions: UTI - Urinary Tract Infection
• Interventions: Drug: potassium citrate; Drug: Nitrofurantoin

• Registration Number: NCT07202832
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-10-15
• Primary Completion: 2026-08-20
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Women aged ≥ 18 and ≤ 50.
• Symptoms of uncomplicated UTI or cystitis; including urinary frequency, urgency and dysuria.
• Positive urine culture of mid-urine urine.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Potassium Citrate Treatment for UTI Symptom Relief	potassium citrate	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.
Nitrofurantoin Antibiotic Treatment for UTI	Nitrofurantoin	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.

Primary Outcome Measures

Name	Time	Method
Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin	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.

Trial Locations

Locations (1)

Urology Department, Faculty of Medicine, Assiut University; 🇪🇬 Asyut, Asyut Governorate, Egypt