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OpenTrials
Completed

NCT Number: NCT06035601

EHR-integrated rUTI Texting Platform

The goal of this clinical trial is to compare a texting platform to usual care for managing recurrent urinary tract infections (UTI).

The main question it aims to answer is:

• can a texting platform that integrates symptom triage and prevention education reduce the rate of unnecessary antibiotics for recurrent UTIs as compared to usual care?

Participants enrolled onto the texting platform will:

• receive evidence-based clinical guidance for the management of symptoms of UTI and receive educational videos on how to prevent UTIs. An important secondary outcome is to determine if the texting platform improves self-efficacy for the management of recurrent UTI.

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Key information

Conditions

Recurrent 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–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Females who currently meet the criteria for recurrent UTIs
  • Age 18 years or older
  • Owns a mobile device with text messaging capability
  • Ability to read and write English
  • Currently receiving care from a provider in Penn Urogynecology or Penn Urology

Exclusion criteria

  • History of known multidrug resistant UTIs
  • History of interstitial cystitis/bladder pain syndrome or current diagnosis of chronic pelvic pain
  • On continuous suppressive antibiotics currently
  • Currently pregnant or within 6 weeks of pregnancy
  • Transplant patient on immunosuppressive medication currently
  • Practice of chronic self-catheterization

Treatment and study plan

EHR-integrated texting platform (Urotrust)

Device
  • An evidence-based algorithm that provides symptom triage and clinical guidance during an episode of acute UTI
  • Evidence-based prevention education material on recurrent UTIs
  • 5 standing orders for urinalysis and urine culture in the EHR upon enrollment
  • Standard-of-care management for recurrent UTI

Usual Care

Other
  • Standard-of-care management of recurrent UTI (phone calls and/or secure EHR messages for acute symptoms) and follow up visits as determined by patients and their providers.

Primary outcomes

  1. Rate of unnecessary antibiotics

    Time frame: 3 months

    Antibiotics prescribed for patients when 1) urine culture is negative and/or urine microscopy has pyuria < 10 WBC/HPF, 2) asymptomatic bacteriuria is present, or 3) there is no urine testing and no urinary symptoms.

Secondary outcomes

  1. Patient self-efficacy

    Time frame: 3 months

    Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)

  2. Patient satisfaction: Patient Global Impression of Improvement score

    Time frame: 3 months

    Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)

  3. Healthcare-related quality of life: EQ-5D-5L score

    Time frame: 3 months

    EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)

  4. Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score

    Time frame: 3 months

    Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)

  5. Healthcare utilization

    Time frame: 3 months

    Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode

  6. Antibiotic prescriptions

    Time frame: 3 months

    Number of antibiotic prescriptions given for UTI episodes

  7. Patient medication compliance

    Time frame: 3 months

    Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Independence Blue Cross

Registry information

Official study title

An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections

Acronym: Urotrust

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Aug 17, 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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