Urine Alkalinization for UTI in Women: RCT

Assiut University

Status: Not yet enrolling

Conditions: UTI - Urinary Tract Infection

Treatments: Drug: Nitrofurantoin; Drug: potassium citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT07202832

PreIRB-Assiut-URO002

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Potassium Citrate Treatment for UTI Symptom Relief

Active Comparator group

Description:

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.

Treatment:

Drug: potassium citrate

Nitrofurantoin Antibiotic Treatment for UTI

Active Comparator group

Description:

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.

Treatment:

Drug: Nitrofurantoin