Reducing Disparities in Urinary Control Symptoms for Minority Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
SUPPORT workbook
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: SUPPORT workbookExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urinary Symptom Changes (UDI Subscale)
To compare changes in urinary symptoms using the validated Urinary Distress Inventory (UDI) subscale of the Pelvic Floor Distress Inventory (PFDI) between baseline and 8-weeks (program completion) in patients undergoing the SUPPORT program. The Urinary Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women. The UDI-6 score is calculated by averaging the responses to each question (possible value 0 to 4), then multiplying that average by 25 to scale the score from 0 to 100. A higher score indicates greater distress.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Urinary symptoms - UDI-6 (16 Weeks)
To compare changes in urinary symptoms using the UDI between baseline and 16 weeks (2 months after program completion) after SUPPORT program initiation. The Urinary Distress Inventory (UDI-6) is a validated 6-item questionnaire that assesses lower urinary tract symptoms, including incontinence, in women. The UDI-6 score is calculated by averaging the responses to each question (possible value 0 to 4), then multiplying that average by 25 to scale the score from 0 to 100. A higher score indicates greater distress.
Time frame
From enrollment to 16 weeks after SUPPORT program initiation2
Urinary symptoms - LURN SI-10 (16 Weeks)
To compare changes in urinary symptoms using the LURN SI-10 between baseline and 16 weeks (2 months after program completion) after SUPPORT program initiation. LURN Symptom Index-10 (LURN SI-10) were developed as patient-reported outcome measures to assess urinary symptoms in adult men and women. Higher scores indicate greater severity of LUTS. Scores on the LURN SI-10 range from 0 (least severe) to 38 (most severe).
Time frame
From enrollment to 16 weeks after SUPPORT program initiation3
Patient Global Impression of Improvement (PGI-I)
To describe self-reported Patient Global Impression of Improvement (PGI-I) scores at 8 and 16 weeks after SUPPORT program initiation. The Patient global impression of improvement scale (PGI-I) is a single-item global rating of change scale that ask an individual patient to rate the severity of a specific condition. There are seven possible responses (scored 1-7): very much better, much better, a little better, no change, a little worse, much worse, and very much worse.
Time frame
From enrollment to 16 weeks after SUPPORT program initiation4
Pelvic Organ prolapse Distress Inventory and Colorectal-Anal distress Inventory subscales
To compare changes in prolapse and bowel symptoms using the Pelvic Organ prolapse Distress Inventory 6 (POPDI-6) and Colorectal-Anal distress Inventory 8 (CRAD-8) at 8 and 16 weeks after SUPPORT program initiation. Both are subscales within the validated PFDI-20 questionnaire, used to assess the severity of symptoms related to pelvic organ prolapse and bowel dysfunction, respectively. Each subscale is calculated by obtaining the mean value of all of the answered items within the corresponding scale (possible value 0 to 4) and then multiplying by 25 to obtain the scale score (range 0 to 100).
Time frame
From enrollment to 16 weeks after SUPPORT program initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chicago
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Northwestern University
Collaborator
Source ClinicalTrials.gov