Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06035601
Other study ID # 853917
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02357758 - Effects of Antibiotic Prophylaxis on Recurrent UTI in Children Phase 4
Completed NCT04306731 - Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections. N/A
Recruiting NCT05553652 - The Effect of ASTARTE™ on Recurrent Urinary Tract Infection N/A
Completed NCT01958073 - Vaginal Estrogen for the Prevention of Recurrent Urinary Tract Infection in Postmenopausal Women Phase 4
Recruiting NCT05652374 - Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study Phase 4
Recruiting NCT06124820 - RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections N/A
Recruiting NCT04807894 - Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo Phase 4
Enrolling by invitation NCT04077580 - The Effect of Methenamine Hippurate to Reduce Antibiotic Prescribing in Elderly Women With Recurrent UTI Phase 4
Terminated NCT03143920 - Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder Early Phase 1
Recruiting NCT04859621 - Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections Phase 2
Terminated NCT04831840 - Recurrent Urinary Tract Infections and the Microbiome
Withdrawn NCT03854396 - Clinical Trial on the Preventive Effect of Intravaginal Prasterone on Recurrent Urinary Tract Infections in Postmenopausal Women Phase 3
Completed NCT02705495 - Acupuncture for Prevention of Recurrent Urinary Tract Infections. N/A
Active, not recruiting NCT05537519 - Phage Therapy for the Treatment of Urinary Tract Infection Phase 1/Phase 2
Not yet recruiting NCT04285320 - Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections Phase 4
Recruiting NCT03142295 - Controlled Human Urine Transfusion for UTI N/A
Recruiting NCT05895578 - Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection. N/A
Completed NCT00214045 - Rigid Versus Flexible Cystoscopy in Women N/A
Enrolling by invitation NCT05551949 - Preventing Recurrent UTI With Vaginal Estrogen Phase 4
Recruiting NCT05472779 - Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections Phase 2