EHR-integrated rUTI Texting Platform

NCT06035601 | Completed FDA Device

• 1 other identifier: 853917
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Urinary Tract Infection

Keywords

unnecessary antibiotics; self-management; digital platform; texting; implementation science; recurrent UTI; healthcare utilization; patient education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Patient self-efficacy

  3 months

• Patient satisfaction: Patient Global Impression of Improvement score

  3 months

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

  3 months

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

  3 months

• Healthcare utilization

  3 months

Study Arms (2)

Electronic health record (EHR)-integrated texting platform

EXPERIMENTAL

Patients will be enrolled into a texting platform for the management of recurrent UTI.

Device: EHR-integrated texting platform (Urotrust)

Usual care

ACTIVE COMPARATOR

Patients will receive usual care through their providers.

Other: Usual care

Interventions

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

Electronic health record (EHR)-integrated texting platform

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Independence Blue Cross: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Agrawal S, Ikpeama N, Koelper N, Dokras A, Harvie H, Hamm RF, Dutcher L, Arya LA. A Randomized Trial of a Texting Platform for Recurrent Urinary Tract Infections. Urogynecology (Phila). 2026 Feb 2. doi: 10.1097/SPV.0000000000001770. Online ahead of print.

  PMID: 41628883 DERIVED

• Arya LA, Agrawal S, Ikpeama N, Harvie H, Feldman RH, Dutcher L. Implementing a Digital Platform for Recurrent Urinary Tract Infections. Urogynecology (Phila). 2025 Mar 1;31(3):183-193. doi: 10.1097/SPV.0000000000001604. Epub 2024 Nov 11.

  PMID: 39527705 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research assistant extracting data on primary and secondary outcomes will be masked to randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of OBGYN

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: March 7, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)