EHR-integrated rUTI Texting Platform

Recurrent Urinary Tract Infection Clinical Trial

— Urotrust  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035601
• Other study ID #: 853917
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Surbhi Agrawal, MD
• Phone: 2676244438
• Email: surbhi.agrawal[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Recurrent Urinary Tract Infection
• Urinary Tract Infections

Intervention

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

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Independence Blue Cross

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of unnecessary antibiotics	Antibiotics prescribed for patients with negative urine culture or for patients with asymptomatic bacteriuria (positive urine culture but no symptoms suggestive of UTI)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Healthcare utilization	Combined number of phone calls, secure messages, telehealth, and/or in-person visits per UTI episode	3 months
Secondary	Antibiotic prescriptions	Number of antibiotic prescriptions given for UTI episodes	3 months
Secondary	Patient medication compliance	Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)	3 months