Program to help minority women manage urinary control symptoms
Reducing Disparities in Urinary Control Symptoms for Minority Women
This study is trying out a new home program to help minority women manage urinary control issues and see if it works well for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06798311 on ClinicalTrials.gov |
What this trial studies
This program aims to reduce disparities in treatment for urinary incontinence and lower urinary tract symptoms among minority women. Developed by experts in urogynecology, psychology, and physical therapy, it features a culturally adapted, self-directed, 8-week home-based module. The SUPPORT program combines cognitive behavioral therapy, behavioral modifications, and physical therapy exercises, with support from research staff to guide participants. The study evaluates the feasibility and acceptability of this program and its impact on treatment outcomes across different racial and ethnic groups.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who experience bothersome urinary incontinence or lower urinary tract symptoms and are willing to engage in conservative treatment.
Not a fit: Patients with severe pelvic organ prolapse, those currently on medications for urinary issues, or individuals with certain mobility or neurological disorders may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for minority women suffering from urinary control issues.
How similar studies have performed: Other studies have shown success with culturally adapted interventions for similar conditions, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Not_yet_recruiting)
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Kenton, MD — University of Chicago
- Study coordinator: Jinxuan (Rowena) Shi, MA
- Email: jinxuan.shi@bsd.uchicago.edu
- Phone: 773-795-2731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.