Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06798311

Conditions

Urinary Incontinence (UI)

Lower Urinary Tract Symptoms (LUTS)

Pelvic Floor Disorder

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SUPPORT workbook

Study Details

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.

Conditions

Urinary Incontinence (UI)

Lower Urinary Tract Symptoms (LUTS)

Pelvic Floor Disorder

Study ID

NCT06798311

Start date

Oct 28, 2024

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SUPPORT workbook

All enrolled patients will be given access to the SUPPORT workbook (hard copy and PDF). 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. Patients also will 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.

Interventions

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 measure

  • Urinary Symptom Changes (UDI Subscale) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Jinxuan (Rowena) Shi, MA

773-795-2731jinxuan.shi@bsd.uchicago.edu

Tara Samsel, BS

773-795-2729tara.samsel@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jinxuan Shi, MS

773-795-2731jinxuan.shi@bsd.uchicago.edu

Tara Samsel, BS

7737952729tara.samsel@bsd.uchicago.edu

Principal Investigator:

Kimberly Kenton, MD

More Information

Sponsor

University of Chicago

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • cognitive behavioral therapy
  • self-directed
  • physical therapy
  • behavioral modifications
  • pelvic floor
  • home-based
  • health disparities

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-07.