Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06798311

Reducing Disparities in Urinary Control Symptoms for Minority Women Using a Self-Directed Support Program Combining Behavioral Therapy and Physical Therapy Exercises

Led by University of Chicago · Updated on 2026-04-07

80

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a self-directed, culturally adapted home-based program called SUPPORT designed for women with urinary incontinence (UI) and lower urinary tract symptoms (LUTS). This program addresses disparities in access to conservative treatments by combining cognitive behavioral therapy, behavioral changes, and pelvic floor physical therapy exercises. The study focuses on racially minoritized women and aims to assess the feasibility, acceptability, and impact of the SUPPORT program on patient-centered outcomes across different races and ethnicities. Participants receive an 8-week SUPPORT workbook that includes education, bladder retraining, pelvic floor stretching, and core strengthening exercises. The workbook also features QR codes linking to videos demonstrating exercises with audio guidance. Additionally, participants have access to a custom programmed GPT-based digital coach trained to assist them empathetically throughout the program. The total time commitment is about 2 hours per week. During the study, participants progress through the home-based program with research staff support and complete surveys evaluating urinary symptom changes from enrollment to 8 weeks and up to 16 weeks after starting. Researchers measure adherence, patient satisfaction, symptom improvement, and the usability and attitudes toward the digital coach. The study helps understand how self-management strategies can be effectively delivered for pelvic floor disorders over about four months.

CONDITIONS

Brief Title

Reducing Disparities in Urinary Control Symptoms for Minority Women

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able to converse in English
  • At least somewhat bothered by urinary incontinence, urinary frequency, or urgency
  • Willing to engage in conservative treatment for urinary symptoms for 16 weeks
Not Eligible

You will not qualify if you...

  • Pelvic organ prolapse beyond the hymen
  • Currently taking medications for urinary symptoms or history of surgery for urinary incontinence
  • Abnormal post-void residual and positive urine culture at study entry
  • History of recurrent urinary tract infections
  • Mobility or neurologic disorders preventing home physical therapy
  • Planning to start physical therapy within the next 16 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants engage in the SUPPORT program, a self-directed, home-based behavioral therapy and physical therapy exercise program for urinary symptoms. The program includes education, bladder re-training exercises, pelvic floor stretching, core strengthening, and cognitive behavioral therapy, supported by a digital health coach.

Weekly remote check-ins with research staff

Follow-up

Duration - 8 weeks

Participants are monitored for continued urinary symptom changes, adherence, satisfaction, and outcomes after completing the SUPPORT program.

1 to 2 remote assessments

Trial Site Locations

Total: 2 locations

1

Northwestern University

Chicago, Illinois, United States, 60611

Not Yet Recruiting

2

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

J

Jinxuan (Rowena) Shi, MA

T

Tara Samsel, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Elizabeth C Stade, Shannon Wiltsey Stirman, Lyle H Ungar...

https://pubmed.ncbi.nlm.nih.gov/38609507

American Urogynecologic Society Systematic Review: The Impact of Weight Loss Intervention on Lower Urinary Tract Symptoms and Urinary Incontinence in Overweight and Obese Women.

Tajnoos Yazdany, Sharon Jakus-Waldman, Peter C Jeppson...

https://pubmed.ncbi.nlm.nih.gov/31860569

Compliance With Pelvic Floor Physical Therapy in Patients Diagnosed With High-Tone Pelvic Floor Disorders.

Katherine L Woodburn, Misha C Tran, Viviana Casas-Puig...

https://pubmed.ncbi.nlm.nih.gov/31045618

Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial.

Thorgerdur Sigurdardottir, Thora Steingrimsdottir, Reynir T Geirsson...

https://pubmed.ncbi.nlm.nih.gov/31526791