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Urine Alkalinization for UTI in Women: RCT

NCT07202832 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Amr Darwish, Lecturer · Urology Department, Faculty of Medicine, Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-08-20
Completion
2027-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07202832 on ClinicalTrials.gov