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Behavioural Intervention

SUPPORT Workbook for Urinary Incontinence (SUPPORT Trial)

Chicago, IL

N/A

Recruiting

Led By Kimberly Kenton, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Anterior or posterior pelvic organ prolapse beyond the hymen or apical prolapse to the hymen

Patients with abnormal PVR and positive urine culture at time of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of treatment at 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to create a program called SUPPORT to help racially minoritized women with urinary incontinence and lower urinary tract symptoms. The program combines various evidence-based treatments like cognitive behavioral therapy and physical therapy

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Who is the study for?

This trial is for racially minoritized women experiencing urinary control symptoms or infections. Participants should be interested in a home-based, self-directed treatment program and willing to engage with the SUPPORT workbook and exercises over an 8-week period.Check my eligibility

What is being tested?

The study tests the SUPPORT program, which includes cognitive behavioral therapy, lifestyle changes, and physical exercises for treating urinary issues. It's culturally tailored for minority women and supported by research staff. The impact of this 8-week home module on patient outcomes will be evaluated.See study design

What are the potential side effects?

Since the intervention involves non-invasive treatments like education, behavior modification, and physical therapy exercises rather than medication or surgery, significant side effects are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My pelvic organs have dropped beyond the vaginal opening.

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I have a bladder emptying problem and a urinary infection.

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I have had multiple urinary tract infections.

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I do not have any conditions that stop me from doing physical therapy at home.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of treatment at 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of treatment at 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of treatment at 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urinary Symptom Changes (UDI Subscale)

Secondary study objectives

Adherence

Attitudes toward Large Language Model Use (WAI-TECH-SF - Working Alliance Inventory for Online Interventions-Short Form)

Large Language Model usability (SUS - the System Usability Scale)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SUPPORT workbookExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met