The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire.
Matthew D Barber, Cathie Spino, Nancy K Janz...
https://pubmed.ncbi.nlm.nih.gov/19375574/Actively Recruiting
Led by University of Chicago · Updated on 2026-04-07
80
Participants Needed
2
Research Sites
N/A
Total Duration
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
Reducing Disparities in Urinary Control Symptoms for Minority Women
J
Jinxuan (Rowena) Shi, MA
T
Tara Samsel, BS
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University of Chicago
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | SUPPORT Workbook (At-Home Digital Program) | Standard In-Person Pelvic Floor Physical Therapy (PFPT) |
|---|---|---|
| What it is | A structured, self-guided workbook-based program that teaches pelvic floor physical therapy techniques (bladder retraining, stretching, core strengthening), offers cognitive behavioral therapy exercises for coping and motivation, and provides digital support via QR-coded instructional videos and access to a dedicated virtual health coach (large language model). | A clinician-supervised therapy program in which a specialized pelvic health physical therapist teaches and monitors pelvic floor muscle exercises, provides education, and tailors behavioral strategies to the patient in scheduled in-person visits. |
| Role in trial | All enrolled participants receive the SUPPORT program as the investigational intervention. No concurrent comparator or randomization. | Not tested within the trial; provided here as the best established current-care option for women with urinary incontinence who might otherwise seek in-person structured PFPT. |
| Primary use | Designed to reduce urinary incontinence symptoms and improve bladder health and quality of life for women, with particular focus on addressing disparities among Hispanic and Black women. | First-line, guideline-recommended non-surgical treatment to decrease urinary incontinence, urgency, frequency, and associated distress in women. |
| How it is given or performed | Participants use the SUPPORT workbook at home for 16 weeks, following educational modules, guided video exercise demonstrations, CBT exercises, and digital health coach instructions. Recommended time commitment is about 2 hours per week. | Pelvic floor muscle training and bladder retraining are conducted during in-person appointments, initially with hands-on assessment and exercise instruction, followed by periodic follow-up and progression. Most programs involve 6–12 supervised sessions over several weeks, with daily practice required between visits. |
| Evidence status | Currently under clinical investigation. Results for efficacy or superiority are not yet available from completed trials. | Multiple randomized trials and systematic reviews show that supervised pelvic floor muscle training significantly reduces the frequency and distress of urinary incontinence compared to no treatment or inactive controls. |
| Important limitations | Long-term effectiveness and comparative benefit versus supervised PFPT remain unproven; intervention depends on participant motivation and self-guidance at home. Results may not apply to all women or those with complicating pelvic floor conditions. | Requires regular visits to a clinic and access to a trained pelvic floor physical therapist; adherence to prescribed exercises between appointments can impact outcomes. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/29634445/University of Chicago
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor