Reducing Disparities in Urinary Control Symptoms for Minority Women

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

SUPPORT workbook

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.

Sponsors & Collaborators

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

  collaborator NIH

• Northwestern University

  collaborator OTHER

• University of Chicago

  lead OTHER

Principal Investigators

• Kimberly Kenton, MD · University of Chicago

• James Griffith, PhD · University of Chicago

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-28

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• United States

Study Locations