Reducing Disparities in Urinary Control Symptoms for Minority Women

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence (UI), Lower Urinary Tract Symptoms (LUTS), Pelvic Floor Disorder

In brief

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.

Key facts

Study ID

NCT06798311

Run by

University of Chicago

People needed

80

Starts

2024-10-28

Expected to finish

2027-05-01

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• History of mobility or neurologic disorders that would prevent ability to complete at home physical therapy
• Planning to start PT within the next 16 weeks

Where it is running

• The University of Chicago — Chicago, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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