Urine pH and Urinary Tract Infection (PHURINE)

Consequences of UTI on Urine pH

Urinary tract infections (UTI) affect the urine pH and may lead to salt precipitation such as struvite. Bacteria with urease activity are known to alkalinise urine, but not much is known on how pH is changing over time during UTI.

This study aims at following urine pH progression at the time of diagnosis of UTI and during the treatment phase.

Description of the change in urine pH over time will help understanding the risk of struvite formation and potential timing of intervention.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infections; Urinary Stone

Detailed Description

Adults presenting with UTI symptoms will be screened for infection and instructed to monitor urine pH during the course of treatment and 1 week after. Urine pH will be measured by the patients using calibrated pH-stix. Type of bacteria, antibiotics, and the type of diet will be monitored during the study.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Charlotte Desponds, BM; Phone Number: +41795561934; Email: Charlotte.Desponds@unil.ch
• Study Contact Backup: Name: Alexandre Gouveia, MD; Email: Alexandre.Gouveia@unisante.ch

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Recruiting
      • Unisanté
      • Contact: Alexandre Gouveia, MD; Phone Number: +41213144905; Email: Alexandre.Gouveia@unisant.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient consulting the primary care unit of the medical outpatient clinic UniSanté in Lausanne will be asked to participate.

Description

Group 1. Cystitis

Inclusion Criteria:

• Symptoms of dysuria, pollakiuria, no fever AND
• urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)

Group 2. Pyelonephritis

Inclusion Criteria:

• Unilateral flank pain, pollakiuria, dysuria, fever (>38.5°C) AND
• urine-stix positive for leucocytes OR positive culture (>10E5 cfu/ml)

Exclusion Criteria (both groups):

• known urinary tract anatomic abnormalities
• Presence of a urine catheter
• Sepsis - septic shock
• Patient taking drug interfering with urine pH (diuretics, citrate, acetazolamide, topiramate,...)
• Patients with UTI diagnosed in the preceding month
• Patients having received antibiotics during the preceding month
• Male patient with a diagnosis of prostatitis
• Presence of infected kidney cyst
• Patient with diabetes
• Pregnant female
• Patient with obstructive pyelonephritis

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cystitis; Patients with lower UTI will be included in this group
Pyelonephritis; Patients with higher UTI will be included in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine pH	Urine pH is monitored by the patient every morning during the treatment phase and 7 days after the end of treatment	21 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Olivier Bonny, MD-PhD, CHUV-Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 13, 2021

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: urine pH
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Infections; Urinary Tract Infections; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 2020-00779

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
• product manufactured in and exported from the U.S.: No