Recurrent Urinary Tract InfectionUrotrustNCT06035601
EHR-integrated rUTI Texting Platform
A study testing EHR-integrated texting platform (Urotrust) in people with Recurrent Urinary Tract Infection, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- EHR-integrated texting platform (Urotrust)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- EHR-integrated texting platform (Urotrust), Usual care
- Keywords
- unnecessary antibiotics, self-management, digital platform, texting, implementation science, recurrent UTI, healthcare utilization, patient education
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 careOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Electronic health record (EHR)-integrated texting platform | Experimental | Patients will be enrolled into a texting platform for the management of recurrent UTI. Receives: Device: EHR-integrated texting platform (Urotrust) |
| Usual care | Active comparator | Patients will receive usual care through their providers. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (7)
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)
Measured: 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).
Measured: 3 months
Healthcare-related Quality of Life: EQ-5D-5L Score
EuroQol 5-Dimension 5-Level (EQ-5D-5L) score which assesses how good or bad their health is on a scale from 0 to 100 with a higher score indicating better health status.
Measured: 3 months
Healthcare-related Quality of Life: Recurrent UTI Impact Questionnaire Score
Recurrent Urinary Tract Infection Impact Questionnaire score. Scores range from 0 to 100, with greater scores indicating greater overall UTI symptom and pain severity.
Measured: 3 months
Healthcare Utilization
Combined number of phone calls, secure messages per UTI episode
Measured: 3 months
Antibiotic Prescriptions
Number of antibiotic prescriptions given for UTI episodes
Measured: 3 months
Patient Medication Compliance
Medication Adherence Self-Report Inventory score (score range 0-100 with 0 indicating no medication usage)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Mar 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Independence Blue Cross
- Responsible party
- Principal investigator, Lily Arya, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035601
- Sponsor's protocol ID
- 853917
- Acronym
- Urotrust
- Status last verified
- Jul 2026
- First submitted
- 6 Sep 2023
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
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 Mar 1;32(3):162-171. doi: 10.1097/SPV.0000000000001770.
PubMed 41628883Arya 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.
PubMed 39527705
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EHR-integrated Texting Platform to Promote Self-management in Women With Recurrent Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT06035601
- Acronym / sponsor ID
- Urotrust / 853917
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- unnecessary antibiotics, self-management, digital platform, texting, implementation science, recurrent UTI, healthcare utilization, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Independence Blue Cross
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic health record (EHR)-integrated texting platform | Experimental | Device: EHR-integrated texting platform (Urotrust)Patients will be enrolled into a texting platform for the management of recurrent UTI. |
| Usual care | Active comparator | Other: Usual carePatients will receive usual care through their providers. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Electronic health record (EHR)-integrated texting platform |
| 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. | Other | Usual care |
Primary outcome
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.
7 secondary outcomes
Patient Self-efficacy
Time frame: 3 months
Patient Satisfaction: Patient Global Impression of Improvement Score
Time frame: 3 months
Healthcare-related Quality of Life: EQ-5D-5L Score
Time frame: 3 months
Healthcare-related Quality of Life: Recurrent UTI Impact Questionnaire Score
Time frame: 3 months
Healthcare Utilization
Time frame: 3 months
Antibiotic Prescriptions
Time frame: 3 months
Patient Medication Compliance
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41628883Agrawal 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 Mar 1;32(3):162-171. doi: 10.1097/SPV.0000000000001770.
- Derived from this study: PubMed 39527705Arya 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.
- Individual participant dataSharing planned: Yes
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Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women
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Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.
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Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR-integrated texting platform (Urotrust) in people with Recurrent Urinary Tract Infection, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Unnecessary Antibiotics (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035601, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.