Urine Alkalinization for UTI in Women: RCT

NCT ID: NCT07202832

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-01-01

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

Conditions

UTI - Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

potassium citrate

Intervention Type: DRUG

Potassium citrate is a medication used to alkalinize the urine, providing symptomatic relief of dysuria in patients with urinary tract infections (UTIs). In this study, participants in Arm 1 will receive potassium citrate for a period of 7 days. The treatment is aimed at reducing discomfort related to UTIs, such as burning sensations during urination and suprapubic pain. In addition to symptomatic relief, the intervention may also enhance bacterial phagocytosis and bacterial killing in the urine. Participants will be monitored for any side effects or adverse events during the treatment period.

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.

Group Type: ACTIVE_COMPARATOR

Nitrofurantoin

Intervention Type: DRUG

Nitrofurantoin is an antibiotic commonly used to treat uncomplicated urinary tract infections (UTIs). In this arm, participants will receive Nitrofurantoin for 7 days to treat their UTI. The primary objective is to evaluate its effectiveness in reducing UTI symptoms, such as dysuria, urgency, frequency, and suprapubic discomfort. This intervention will be compared with the urinary alkalinization therapy used in Arm 1. Researchers will also monitor changes in urine culture and any adverse events related to the antibiotic treatment.

Interventions

potassium citrate

Potassium citrate is a medication used to alkalinize the urine, providing symptomatic relief of dysuria in patients with urinary tract infections (UTIs). In this study, participants in Arm 1 will receive potassium citrate for a period of 7 days. The treatment is aimed at reducing discomfort related to UTIs, such as burning sensations during urination and suprapubic pain. In addition to symptomatic relief, the intervention may also enhance bacterial phagocytosis and bacterial killing in the urine. Participants will be monitored for any side effects or adverse events during the treatment period.

Intervention Type: DRUG

Nitrofurantoin

Nitrofurantoin is an antibiotic commonly used to treat uncomplicated urinary tract infections (UTIs). In this arm, participants will receive Nitrofurantoin for 7 days to treat their UTI. The primary objective is to evaluate its effectiveness in reducing UTI symptoms, such as dysuria, urgency, frequency, and suprapubic discomfort. This intervention will be compared with the urinary alkalinization therapy used in Arm 1. Researchers will also monitor changes in urine culture and any adverse events related to the antibiotic treatment.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amr Esam Saad Mohamed Darwish

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Darwish, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Urology Department, Faculty of Medicine, Assiut University

Locations

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Hamza Elhashamy, MBBCh

Role: CONTACT

Hamza.Ahmed00099@med.aun.edu.eg

+201028635437

Abdelrahman Abdelshafi, MBBCh

Role: CONTACT

abdulrahman.18313572@med.aun.edu.eg

+201123740500

Facility Contacts

Hamza Elhashamy, MBBCh

Role: primary

Hamza.Ahmed00099@med.aun.edu.eg

+201028635437

Abdelrahman Abdelshafi, MBBCh

Role: backup

abdulrahman.18313572@med.aun.edu.eg

+201123740500

Other Identifiers

PreIRB-Assiut-URO002

Identifier Type: -

Identifier Source: org_study_id