Reducing Disparities in Urinary Control Symptoms for Minority Women

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06798311
Status
Recruiting
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Conditions

  • Lower Urinary Tract Symptoms (LUTS)
  • Pelvic Floor Disorder
  • Urinary Incontinence (UI)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SUPPORT workbook — BEHAVIORAL
    The SUPPORT workbook contains a template for how pelvic floor physical therapy is delivered in the typical in-person setting with a combination of education, bladder re-training exercises, pelvic floor stretching and core strengthening. To aid in the demonstration of physical therapy exercises, the workbook includes QR-coded links to videos of a physical therapist performing the exercises in an ideal form. The videos include audio instruction to ensure that patients can learn the concepts in either visual, auditory or written form. The cognitive behavioral therapy (CBT) portion of the workbook is adapted from the standardized CBT protocol and includes short introductions and exercises pertaining to cognitive flexibility, behavioral activation and social support. The total time commitment for the program is 2-hours per week. Patients also will be given access to a custom programmed GPT trained on the SUPPORT workbook and given instructions on empathetic communication techniques.

Study Details

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 Dates

Start date
Oct 28, 2024
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SUPPORT workbook
    All enrolled patients will be given access to the SUPPORT workbook (hard copy and PDF). The SUPPORT workbook contains a template for how pelvic floor physical therapy is delivered in the typical in-person setting with a combination of education, bladder re-training exercises, pelvic floor stretching and core strengthening. Patients also will 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.

Primary Outcome Measure

Urinary Symptom Changes (UDI Subscale) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Julia Geynisman-Tan, MD
[email protected]
312-695-4623
Oluwateniola Brown, MD (SUB_INVESTIGATOR)
Julia Geynisman-Tan, MD (SUB_INVESTIGATOR)
Melissa Simon, MD (PRINCIPAL_INVESTIGATOR)
The University of ChicagoChicagoIllinois60637
Jinxuan Shi, MS
[email protected]
773-795-2731
Tara Samsel, BS
[email protected]
7737952729
Kimberly Kenton, MD (PRINCIPAL_INVESTIGATOR)
James Griffith, PhD (SUB_INVESTIGATOR)
Margaret Mueller, MD (SUB_INVESTIGATOR)
Sarah Collins, MD (SUB_INVESTIGATOR)
Christina Lewicky-Gaupp, MD (SUB_INVESTIGATOR)
Juraj Letko, MD (SUB_INVESTIGATOR)

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