NCT06798311 Reducing Disparities in Urinary Control Symptoms for Minority Women
| NCT ID | NCT06798311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Urinary Incontinence (UI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-10-28 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Kimberly Kenton, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT06798311 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Incontinence (UI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06798311 currently recruiting?
Yes, NCT06798311 is actively recruiting participants. Contact the research team at jinxuan.shi@bsd.uchicago.edu for enrollment information.
Where is the NCT06798311 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States.
Who is sponsoring the NCT06798311 clinical trial?
NCT06798311 is sponsored by University of Chicago. The principal investigator is Kimberly Kenton, MD at University of Chicago. The trial plans to enroll 80 participants.