Reducing Disparities in Urinary Control Symptoms for Minority Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago

About this trial

The study is designed to address the disparity in available conservative/behavioral treatments for UI/LUTS. The program was developed by experts from urogynecology, psychology, and physical therapy then modified based on focus group feedback from racially minoritized women. The study team created a patient-centered, culturally adapted, self-directed, 8-week, home-based module for women with LUTS/UI. The SUPPORT program combines multiple evidence-based conservative treatments for LUTS/UI including cognitive behavioral therapy, behavioral modifications, and home physical therapy exercise. Progression through the home-based program is supported by research staff. This prospective interventional study aims to evaluate the feasibility and acceptability of the SUPPORT program and its impact on patient-centered treatment outcomes, while enabling comparisons across race and ethnicity. This approach will provide a comprehensive understanding of how to effectively deliver self-management strategies for pelvic floor disorders.

At the start of the 8 week SUPPORT course participants will also be given access to a custom programmed GPT trained on the SUPPORT workbook and given instructions on empathetic communication techniques and assisting patients in performing the SUPPORT exercises as outlined in the program. At the end of 8 weeks patients will fill out a survey assessing the frequency of use and interactions with the LLM.

Eligibility criteria

Qualifiers

Age 18 years or older

Able to converse in English

A response of at least "somewhat bothered" by urinary incontinence, urinary frequency or urgency on the UDI

Willing to engage in conservative treatment of their UI/LUTS for 16 weeks

Disqualifiers

Anterior or posterior pelvic organ prolapse beyond the hymen or apical prolapse to the hymen

Currently taking medications for their UI/LUTS or history of surgical intervention for UI

Patients with abnormal PVR and positive urine culture at time of study entry

History of recurrent UTIs

Trial design

Treatments tested in this trial

  • SUPPORT workbook

Treatment groups

80 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Chicago

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Northwestern University

Collaborator