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
Sponsors and collaborators
University of Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Northwestern University
Collaborator