Texting Platform for Recurrent UTIs

(Urotrust Trial)

Overseen By Lily Arya, MD, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must not be taking: Suppressive antibiotics, Immunosuppressive

Disqualifiers: Multidrug resistant UTIs, Interstitial cystitis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a texting platform can manage recurrent urinary tract infections (UTIs) more effectively than usual care. The EHR-integrated rUTI Texting Platform offers guidance on symptoms and educational videos to help prevent UTIs. The study aims to determine if this approach reduces unnecessary antibiotic use and boosts confidence in managing UTIs. Ideal participants are women with recurring UTIs who can receive text messages on their phones. As an unphased trial, this study allows participants to contribute to innovative research that could enhance UTI management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on continuous suppressive antibiotics, you cannot participate.

What prior data suggests that this texting platform is safe for managing recurrent UTIs?

Research has shown that digital health tools, such as the texting platform under study for managing recurring urinary tract infections (UTIs), are generally safe for users. This platform provides advice and information to help manage UTI symptoms and prevent future infections. Since the study examines a texting platform rather than medication or surgery, safety concerns are typically fewer.

No specific negative effects have been reported for this type of platform. The goal is to help people manage their symptoms better and reduce unnecessary antibiotic use. As a digital tool, it presents much lower safety concerns compared to traditional medical treatments. Participants can feel confident that using the platform is unlikely to pose significant health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EHR-integrated rUTI Texting Platform because it offers a unique approach to managing recurrent urinary tract infections (rUTIs). Unlike traditional treatments that typically rely on antibiotics, this platform leverages technology to improve patient engagement and monitoring. By integrating with electronic health records, it allows for real-time communication and personalized care, potentially reducing the frequency of infections and improving overall patient outcomes. This tech-savvy method aims to enhance the management of rUTIs, offering a modern twist to standard care practices.

What evidence suggests that this texting platform is effective for managing recurrent UTIs?

Research has shown that digital health tools can help manage conditions like recurring urinary tract infections (UTIs). In this trial, participants may use an EHR-integrated texting platform designed for managing recurrent UTIs. Studies have found that such a texting system can offer reliable advice and educate patients about symptoms and prevention. Early results suggest this method might reduce unnecessary antibiotic use by helping people better understand and manage UTI symptoms. By providing timely advice and prevention tips, these tools aim to empower patients to take charge of their health, potentially leading to better health outcomes and fewer UTIs. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for women over 18 with recurrent UTIs who can give informed consent, follow the study procedures, and have a mobile device that can text. They must be able to read/write English but cannot join if they have urinary system anomalies, certain bladder conditions, recent pregnancy, uncontrolled diabetes or are on specific medications.

Inclusion Criteria

Ability to read and write English

Owns a mobile device with text messaging capability

Provision of signed and dated informed consent form

Exclusion Criteria

I have had cancer in my urinary tract, with or without radiation treatment.

My diabetes is not well-controlled (HbA1c > 9).

I have been using self-catheterization for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive evidence-based clinical guidance and educational videos for managing recurrent UTIs via a texting platform

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EHR-integrated rUTI Texting Platform

Trial Overview Researchers are testing whether an EHR-integrated texting platform offering guidance and education on managing recurrent UTIs improves patients' confidence in handling their condition compared to usual care. The effectiveness will be measured by changes in self-efficacy scores after using the platform.

How Is the Trial Designed?

Group I: Electronic health record (EHR)-integrated texting platform Experimental Treatment 1 Intervention

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

Group II: Usual care Active Control 1 Intervention

Patients will receive usual care through their providers.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Independence Blue Cross

Collaborator

Trials

7

Recruited

126,000+

Published Research Related to This Trial

Women with recurrent urinary tract infections (rUTIs) experience significant chronic impacts on their lives, highlighting the need for better management strategies and support.

Both patients and healthcare professionals express concerns about antibiotic use for rUTIs, indicating a need for more research into non-antibiotic treatment options and improved communication regarding treatment expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' and Healthcare Professionals' Experiences and Views of Recurrent Urinary Tract Infections in Women: Qualitative Evidence Synthesis and Meta-Ethnography. Sanyaolu, LN., Hayes, CV., Lecky, DM., et al.[2023]

A study of 9990 patients with urinary tract infections (UTIs) revealed that 63.1% had infections caused by antibiotic-resistant microorganisms, highlighting the prevalence of resistance in this population.

Models developed from electronic health records (EHR) showed moderate effectiveness in predicting antibiotic resistance, which can assist healthcare providers in making informed decisions about empiric therapy and ordering urine cultures for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Prediction Model for Antibiotic-Resistant Urinary Tract Infections Using Integrated Electronic Health Records from Multiple Clinics in North-Central Florida. Rich, SN., Jun, I., Bian, J., et al.[2023]

A review of 34 mobile apps for urinary tract infections (UTIs) found that only 11 met the criteria for evaluation, with an average adherence to European Association of Urology (EAU) guidelines of just 31.36%.

Despite high user ratings (average 4.04) and a significant number of downloads, the apps performed poorly in providing effective management strategies for recurrent UTIs, indicating a need for improvement in guideline compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Content Analysis of Mobile Phone Applications for the Diagnosis, Treatment, and Prevention of Urinary Tract Infections, and Their Compliance with European Association of Urology Guidelines on Urological Infections. Vaggers, S., Puri, P., Wagenlehner, F., et al.[2022]

A video-based m-health system significantly improved quality of life and disease severity in 30 patients with Interstitial cystitis/bladder pain syndrome (IC/BPS) over an 8-week intervention, compared to a control group that received standard treatment.

The video intervention was more effective than a previous text-based intervention, demonstrating that multimedia approaches can enhance patient education and symptom management in a short timeframe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Education and Symptom Flare Management Using a Video-based m-Health System for Caring Women With IC/BPS. Lee, MH., Wu, HC., Tseng, CM., et al.[2019]

The computer module for managing uncomplicated urinary tract infections (UTIs) accurately identified 26% of women as eligible for computer-directed therapy (CDT), with a high agreement with clinician diagnoses and positive urine cultures in 67% of cases.

After implementation, 98% of users found the module easy to use, and 95% would recommend it, with only 4% of treated women returning for UTI-related issues within two weeks, indicating both high patient satisfaction and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interactive computer kiosk module for the treatment of recurrent uncomplicated cystitis in women. Aagaard, EM., Nadler, P., Adler, J., et al.[2019]

Recent guidelines emphasize the importance of accurate diagnosis and urine cultures for recurrent urinary tract infections (rUTIs) before starting treatment, moving away from unnecessary antibiotic use.

First-line treatments like trimethoprim-sulfamethoxazole, nitrofurantoin, and fosfomycin are recommended, while non-antibiotic regimens are being explored as effective alternatives to reduce antibiotic resistance and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New paradigms in the management of recurrent urinary tract infections. Taich, L., Zhao, H., Cordero, C., et al.[2021]

The myRUTIcoach eHealth system was well-received by 25 women with recurrent urinary tract infections (rUTI), achieving a high satisfaction rating of 8.0 out of 10, and 89% of participants would recommend it to others.

While myRUTIcoach improved patient knowledge and communication with healthcare professionals, barriers to adoption included the need for better integration with electronic health records, highlighting the complexity of implementing such self-management tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and feasibility of a telemedicine tool for patients with recurrent urinary tract infection: myRUTIcoach. Pat, JJ., Pape, CCET., Steffens, MG., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06035601

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 ...

2. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06035601?keyword=%22Urinary%20Tract%20Infection%22

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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39527705/

Implementing a Digital Platform for Recurrent Urinary Tract ... The proposed model can be used to implement and test a patient-centered evidence-based digital platform for the management of recurrent UTI.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10682280/

Development and feasibility of a telemedicine tool for ... We aimed to develop and test the feasibility of an eHealth system for women with rUTI, named myRUTIcoach, and explored the facilitators and barriers related to ...

5. pfdweek24.eventscribe.net pfdweek24.eventscribe.net/ajaxcalls/PresentationInfo.asp?efp=SEJFVkpKU1kxOTE3MQ&PresentationID=1450682&rnd=0.544014

Evidence-based Texting Platform for Recurrent Urinary ... Our aim was to develop an evidence-based conceptual framework for a digital platform for the management of acute UTI symptoms and the prevention of future ...