Urine Alkalinization for UTI in Women: RCT (UTI)

September 24, 2025 updated by: Amr Esam Saad Mohamed Darwish, Assiut University

Efficacy and Safety of Urine Alkalinization in Treatment of Uncomplicated Urinary Tract Infection in Women: A Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin
Time Frame: 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.
7 days (Participants will be assessed at baseline, day 3, and day 7).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amr Darwish, Lecturer, Urology Department, Faculty of Medicine, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PreIRB-Assiut-URO002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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