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NCT06798311 · ClinicalTrials.gov registry record · NA
Reducing Disparities in Urinary Control Symptoms for Minority Women
A NA study of Lower Urinary Tract Symptoms (LUTS) and Pelvic Floor Disorder, sponsored by University of Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06798311: Recruiting NA study of Lower Urinary Tract Symptoms (LUTS) and Pelvic Floor Disorder, sponsored by University of Chicago.
NCT06798311 is a NA study of Lower Urinary Tract Symptoms (LUTS) and Pelvic Floor Disorder that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06798311, a NA study of Lower Urinary Tract Symptoms (LUTS) and Pelvic Floor Disorder, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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 mu
Conditions Studied
Interventions
- BEHAVIORAL SUPPORT workbook
Study Locations (2)
Illinois
- Northwestern University - Chicago
- The University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT06798311 shows while recruiting
NCT06798311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Lower Urinary Tract Symptoms (LUTS) appearing as the primary indexed condition, and to 1 intervention - of which SUPPORT workbook is the first listed.
NCT06798311 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06798311 about?
NCT06798311 is a clinical study titled "Reducing Disparities in Urinary Control Symptoms for Minority Women". 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 ...
What is the current status of trial NCT06798311?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2024-10-28. Estimated completion is 2026-05.
What conditions does trial NCT06798311 study?
This clinical trial studies the following conditions: Lower Urinary Tract Symptoms (LUTS), Pelvic Floor Disorder, Urinary Incontinence (UI).
What interventions are being tested in trial NCT06798311?
The interventions under investigation include: SUPPORT workbook (BEHAVIORAL).
Who is sponsoring clinical trial NCT06798311?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06798311 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06798311's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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