Urine Alkalinization for UTI in Women: RCT

NCT07202832 | Not Yet Recruiting

• 1 other identifier: PreIRB-Assiut-URO002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Potassium Citrate Treatment for UTI Symptom Relief

ACTIVE COMPARATOR

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

Nitrofurantoin Antibiotic Treatment for UTI

ACTIVE COMPARATOR

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

Interventions

potassium citrate 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.

Potassium Citrate Treatment for UTI Symptom Relief

Nitrofurantoin 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.

Nitrofurantoin Antibiotic Treatment for UTI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Urology Department, Faculty of Medicine, Assiut University

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Potassium Citrate; Nitrofurantoin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrofurans; Nitro Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amr Darwish, Lecturer

  Urology Department, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamza Elhashamy, MBBCh

CONTACT

+201028635437; Hamza.Ahmed00099@med.aun.edu.eg

Abdelrahman Abdelshafi, MBBCh

CONTACT

+201123740500; abdulrahman.18313572@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)