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NCT Number: NCT07202832

Urine Alkalinization for UTI in Women: RCT

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

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Key information

Conditions

UTI - Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Abdelshafi, MBBCh

CONTACT

[email protected]

+201123740500

Hamza Elhashamy, MBBCh

CONTACT

[email protected]

+201028635437

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: UTI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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