EHR-integrated rUTI Texting Platform (Urotrust)

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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Urinary Tract Infection
• Intervention / Treatment: Device: EHR-integrated texting platform (Urotrust); Other: Usual care

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electronic health record (EHR)-integrated texting platform; Patients will be enrolled into a texting platform for the management of recurrent UTI.	Device: EHR-integrated texting platform (Urotrust); 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
Active Comparator: Usual care; Patients will receive usual care through their providers.	Other: Usual care; • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of unnecessary antibiotics	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient self-efficacy	Stanford self-efficacy for managing chronic disease 6-item score (mean score range 1-10 with mean 1 indicating less self-efficacy)	3 months
Patient satisfaction: Patient Global Impression of Improvement score	Patient Global Impression of Improvement score (score range 1-7 with 1 indicating very much better)	3 months
Healthcare-related quality of life: EQ-5D-5L score	EQ-5D-5L score (score range 1-5 for each subscale with 1 indicating no problems)	3 months
Healthcare-related quality of life: Recurrent UTI Impact Questionnaire score	Recurrent UTI Impact Questionnaire score (score range 0-10 for each subscale with 0 indicating strongly disagree)	3 months
Healthcare utilization	Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode	3 months
Antibiotic prescriptions	Number of antibiotic prescriptions given for UTI episodes	3 months
Patient medication compliance	Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)	3 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Independence Blue Cross

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: self-management; patient education; implementation science; digital platform; healthcare utilization; texting; recurrent UTI; unnecessary antibiotics
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Recurrence; Infections; Urinary Tract Infections
• Other Study ID Numbers: 853917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No