NCT06798311 · University of Chicago
Reducing Disparities in Urinary Control Symptoms for Minority Women
(SUPPORT)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Urinary Symptom Changes (UDI Subscale)
Time frame: From enrollment to the end of treatment at 8 weeks
To compare changes in urinary symptoms using the validated Urinary Distress Inventory (UDI) subscale of the Pelvic Floor Distress Inventory (PFDI) between baseline and 8-weeks (program completion) in patients undergoing the SUPPORT program. The Urinary Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women. The UDI-6 score is calculated by averaging the responses to each question (possible value 0 to 4), then multiplying that average by 25 to scale the score from 0 to 100. A higher score indicates greater distress.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Chicago, Illinois
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations