Urine Alkalinization for UTI in Women: RCT (UTI)

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: Not yet recruiting
• Conditions: UTI - Urinary Tract Infection
• Intervention / Treatment: Drug: potassium citrate; Drug: Nitrofurantoin

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamza Elhashamy, MBBCh; Phone Number: +201028635437; Email: Hamza.Ahmed00099@med.aun.edu.eg
• Study Contact Backup: Name: Abdelrahman Abdelshafi, MBBCh; Phone Number: +201123740500; Email: abdulrahman.18313572@med.aun.edu.eg

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Urology Department, Faculty of Medicine, Assiut University
      • Contact: Hamza Elhashamy, MBBCh; Phone Number: +201028635437; Email: Hamza.Ahmed00099@med.aun.edu.eg
      • Contact: Abdelrahman Abdelshafi, MBBCh; Phone Number: +201123740500; Email: abdulrahman.18313572@med.aun.edu.eg
      • Principal Investigator: Amr Darwish, Lecturer

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Symptom Relief (Dysuria, Urgency, and Frequency) in UTI Patients Treated with Potassium Citrate vs. Nitrofurantoin	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

• Sponsor: Assiut University
• Investigators: Principal Investigator: Amr Darwish, Lecturer, Urology Department, Faculty of Medicine, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Estimated): October 2, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Nitro Compounds; Furans; Nitrofurans; Citrates; Tricarboxylic Acids; Citric Acid; Potassium Citrate; Nitrofurantoin
• Other Study ID 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