Clinical trial NCT06798311: Reducing Disparities in Urinary Control Symptoms for Minority Women
Official title: Reducing Disparities in Urinary Control Symptoms for Minority Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence (UI)
Lower Urinary Tract Symptoms (LUTS)
Pelvic Floor Disorder
Keywords: cognitive behavioral therapy
self-directed
physical therapy
behavioral modifications
pelvic floor
home-based
health disparities
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Northwestern University
First posted: 2025-01-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Several recent large, population-based studies report that the prevalence of bothersome urinary incontinence (UI) and lower urinary tract symptoms (LUTS) ranges from 55-73%, and a woman's lifetime risk of surgery for pelvic floor disorders is 20%. In other words, one in every five women can expect to undergo surgery for UI or prolapse by age 80, underscoring the public health impact of these conditions. For perspective, a woman's lifetime risk of breast and lung cancer are 15% and 6%, respectively. Although the lifetime risk of UI/LUTS is significantly higher than that of breast cancer or lung cancer, UI/LUTS have not received the same level of attention by the public or the healthcare community, despite the severe consequences on quality of life. Women are often embarrassed to seek treatment and lack knowledge about how to manage these bothersome conditions. These barriers lead to reduced healthcare-seeking for these disorders, which further exacerbates the detrimental consequences for quality of life. Similarly, the study team recently found in a geographically diverse, population-based study that housing insecurity, unreliable transportation, housing insecurity, not having enough money to make ends meet, and percent federal poverty levels of 300% or less were associated with more LUTS and lower perceived bladder health.

Additionally, there are disparities in access to treatment for PFDs and inclusion in PFD research for racially minoritized women. One important disparity is the lack of access to evidence-based non-surgical options (e.g., diet and weight loss counseling, behavioral modification, physical therapy (PT), and cognitive behavioral therapy (CBT)) that should be recommended to most women because these treatments can treat multiple PFDs and restore quality of life without the need for more invasive approaches. These conservative interventions are often not offered to racially minoritized women due to poor access and coverage. Improving non-surgical treatment of bladder symptoms is crucial because treatments are complex and multidimensional; treating one symptom surgically can sometimes exacerbate other symptoms. Up to 6% of women who have surgery for stress urinary incontinence (SUI) will undergo a second surgery within 9 years. Women are also at increased risk for de novo urinary symptoms (urinary incontinence and urinary tract infection) after surgical interventions. Likewise, bladder symptoms lead to emotional distress (i.e., anxiety and depression), and in turn, emotional distress can exacerbate UI/LUTS. In order to prevent this cycle of cumulative symptoms and distress, environmental barriers to LUTS must be reduced, and publicly-insured women of low socio-economic status should be able to have the same access to non-surgical interventions as privately insured women.

Pelvic floor physical therapy (PFPT) is a well-established first-line treatment for UI/LUTS. A 2014 Cochrane Review, which included 21 trials with 1281 incontinent women, compared pelvic floor muscle exercises to sham or control treatments. Patients who performed pelvic floor muscle exercises were 17 times more likely to be cured or improved. Standard pelvic floor physical therapy, which combines behavioral retraining and manual muscle therapy, takes 8-12 sessions and requires insurance coverage, copays, travel, a significant time commitment, and effective communication with the therapist. Although some hospitals employ pelvic floor physical therapists, most operate within private practices and do not work with Medicaid or Medicare payers. Likely as a result of these disparities, prior studies have found that racially minoritized women are more likely to assume that surgery is the only treatment option for PFDs.

This study is designed to address the disparity in available conservative/behavioral treatments for UI/LUTS. The investigators 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 exercises. The program was developed by experts from urogynecology, psychology, and physical therapy, and then modified based on focus group feedback from racially minoritized women. The inclusion of women from all races and ethnicities in the study will allow for comparisons across groups, providing the fullest understanding of how to deliver effective self-management for pelvic floor disorders. Progression through the home-based program is supported by research staff. The aim of this prospective interventional study is to assess the feasibility and acceptability of the SUPPORT program and its impact on patient-centered treatment outcomes.

The SUPPORT workbook follows 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. The educational topics were chosen by consensus among the clinical experts as the most common and important clinical contributors to UI/LUTS symptoms and common areas of patient misinformation.

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.

Recognizing the limited time that patients have to engage with this intervention and mimicking the time commitment of standard pelvic floor PT, the investigators aimed to have the program take no more than 2 hours per week. This time commitment is split between time dedicated to reading the chapter, time spent completing the physical therapy or cognitive behavioral therapy exercises on a daily basis, and the time spent engaging in physical activity of the patient's choosing. Patients are counseled that exercise is important to the program as it improves core strength, pelvic floor mobility, bowel motility, and behavioral activation while reducing anxiety.

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.

Recent advances in artificial intelligence, particularly in the development of large language models (LLMs), have opened new possibilities in healthcare. The investigators also aim to explore the use of a customized LLM-based health coach to assist women participating in the SUPPORT program. By providing real-time support and guidance, the AI health coach could help overcome barriers to care and keep patients engaged in the treatment. This approach has the potential to enhance the effectiveness of self-management programs for pelvic floor disorders, making care more accessible and helping more women achieve better health outcomes.

Major goals of the study include:

Aim 1. To use a human-centered, iterative approach with qualitative interviews to create and adapt a self-managed CBT (SM-CBT) intervention along with a self-directed behavioral modification/PT (Home PT) program for women with UI/LUTS from all races and ethnicities, including those who are minority, low-income, and publicly insured.

Aim 2. To determine the efficacy of the SUPPORT intervention on UI/LUTS outcomes as well as patient acceptability and adherence.

Aim 3. To evaluate a large language model-based digital coach's ability to be integrated into a self-managed pelvic floor program.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary Symptom Changes (UDI Subscale)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Urinary symptoms - UDI-6 (16 Weeks)
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Urinary symptoms - LURN SI-10 (16 Weeks)
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Pelvic Organ prolapse Distress Inventory and Colorectal-Anal distress Inventory subscales
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Adherence
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Patient Satisfaction with the SUPPORT Program
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: PROMIS-57 - Patient Reported Outcomes Measurement Information System
timeFrame: From enrollment to 16 weeks after SUPPORT program initiation
measure: Large Language Model usability (SUS - the System Usability Scale)
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Attitudes toward Large Language Model Use (WAI-TECH-SF - Working Alliance Inventory for Online Interventions-Short Form)
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Kimberly Kenton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: James Griffith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zoorob D, Higgins M, Swan K, Cummings J, Dominguez S, Carey E. Barriers to Pelvic Floor Physical Therapy Regarding Treatment of High-Tone Pelvic Floor Dysfunction. Female Pelvic Med Reconstr Surg. 2017 Nov/Dec;23(6):444-448. doi: 10.1097/SPV.0000000000000401.
citation: Clason C, Sterner-Stein K, Hirschman KB, Barg FK, Riegel B. Developing effective health coaches: Experience gained in a clinical trial of a health coach intervention. Patient Educ Couns. 2023 Mar;108:107592. doi: 10.1016/j.pec.2022.107592. Epub 2022 Dec 9.
citation: Al-Anezi FM. Exploring the use of ChatGPT as a virtual health coach for chronic disease management. Learn Health Syst. 2024 Jan 11;8(3):e10406. doi: 10.1002/lrh2.10406. eCollection 2024 Jul.
citation: Hegde N, Vardhan M, Nathani D, Rosenzweig E, Speed C, Karthikesalingam A, Seneviratne M. Infusing behavior science into large language models for activity coaching. PLOS Digit Health. 2024 Apr 2;3(4):e0000431. doi: 10.1371/journal.pdig.0000431. eCollection 2024 Apr.
citation: Stade EC, Stirman SW, Ungar LH, Boland CL, Schwartz HA, Yaden DB, Sedoc J, DeRubeis RJ, Willer R, Eichstaedt JC. Large language models could change the future of behavioral healthcare: a proposal for responsible development and evaluation. Npj Ment Health Res. 2024 Apr 2;3(1):12. doi: 10.1038/s44184-024-00056-z.
citation: Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
citation: Yazdany T, Jakus-Waldman S, Jeppson PC, Schimpf MO, Yurteri-Kaplan LA, Ferzandi TR, Weber-LeBrun E, Knoepp L, Mamik M, Viswanathan M, Ward RM; American Urogynecologic Society. American Urogynecologic Society Systematic Review: The Impact of Weight Loss Intervention on Lower Urinary Tract Symptoms and Urinary Incontinence in Overweight and Obese Women. Female Pelvic Med Reconstr Surg. 2020 Jan/Feb;26(1):16-29. doi: 10.1097/SPV.0000000000000802.
citation: Woodburn KL, Tran MC, Casas-Puig V, Ninivaggio CS, Ferrando CA. Compliance With Pelvic Floor Physical Therapy in Patients Diagnosed With High-Tone Pelvic Floor Disorders. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):94-97. doi: 10.1097/SPV.0000000000000732.
citation: Sigurdardottir T, Steingrimsdottir T, Geirsson RT, Halldorsson TI, Aspelund T, Bo K. Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial. Am J Obstet Gynecol. 2020 Mar;222(3):247.e1-247.e8. doi: 10.1016/j.ajog.2019.09.011. Epub 2019 Sep 14.
citation: Siddiqui NY, Ammarell N, Wu JM, Sandoval JS, Bosworth HB. Urinary Incontinence and Health-Seeking Behavior Among White, Black, and Latina Women. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):340-5. doi: 10.1097/SPV.0000000000000286.
citation: Segal JL, Vassallo B, Kleeman S, Silva WA, Karram MM. Prevalence of persistent and de novo overactive bladder symptoms after the tension-free vaginal tape. Obstet Gynecol. 2004 Dec;104(6):1263-9. doi: 10.1097/01.AOG.0000147596.44421.72.
citation: Rhodes RE, Fiala B. Building motivation and sustainability into the prescription and recommendations for physical activity and exercise therapy: the evidence. Physiother Theory Pract. 2009 Jul;25(5-6):424-41. doi: 10.1080/09593980902835344.
citation: Markland AD, Richter HE, Fwu CW, Eggers P, Kusek JW. Prevalence and trends of urinary incontinence in adults in the United States, 2001 to 2008. J Urol. 2011 Aug;186(2):589-93. doi: 10.1016/j.juro.2011.03.114.
citation: Mandimika CL, Murk W, Mcpencow AM, Lake AG, Miller D, Connell KA, Guess MK. Racial Disparities in Knowledge of Pelvic Floor Disorders Among Community-Dwelling Women. Female Pelvic Med Reconstr Surg. 2015 Sep-Oct;21(5):287-92. doi: 10.1097/SPV.0000000000000182.
citation: Kotarinos RK. Pelvic floor physical therapy in urogynecologic disorders. Curr Womens Health Rep. 2003 Aug;3(4):334-9.
citation: Kiyosaki K, Ackerman AL, Histed S, Sevilla C, Eilber K, Maliski S, Rogers RG, Anger J. Patients' understanding of pelvic floor disorders: what women want to know. Female Pelvic Med Reconstr Surg. 2012 May-Jun;18(3):137-42. doi: 10.1097/SPV.0b013e318254f09c.
citation: Hatchett L, Hebert-Beirne J, Tenfelde S, Lavender MD, Brubaker L. Knowledge and perceptions of pelvic floor disorders among african american and latina women. Female Pelvic Med Reconstr Surg. 2011 Jul;17(4):190-4. doi: 10.1097/SPV.0b013e318229dd5c.
citation: Harlow BL, Bavendam TG, Palmer MH, Brubaker L, Burgio KL, Lukacz ES, Miller JM, Mueller ER, Newman DK, Rickey LM, Sutcliffe S, Simons-Morton D. The Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium: A Transdisciplinary Approach Toward Promoting Bladder Health and Preventing Lower Urinary Tract Symptoms in Women Across the Life Course. J Womens Health (Larchmt). 2018 Mar;27(3):283-289. doi: 10.1089/jwh.2017.6566. Epub 2017 Sep 15.
citation: FitzGerald MP, Kotarinos R. Rehabilitation of the short pelvic floor. II: Treatment of the patient with the short pelvic floor. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Oct;14(4):269-75; discussion 275. doi: 10.1007/s00192-003-1050-7. Epub 2003 Aug 7.
citation: Felde G, Bjelland I, Hunskaar S. Anxiety and depression associated with incontinence in middle-aged women: a large Norwegian cross-sectional study. Int Urogynecol J. 2012 Mar;23(3):299-306. doi: 10.1007/s00192-011-1564-3. Epub 2011 Nov 9.
citation: Dumoulin C, Hay-Smith EJ, Mac Habee-Seguin G. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database Syst Rev. 2014 May 14;(5):CD005654. doi: 10.1002/14651858.CD005654.pub3.
citation: Berger AA, Tan-Kim J, Menefee SA. Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence. Obstet Gynecol. 2019 Nov;134(5):1047-1055. doi: 10.1097/AOG.0000000000003526.
citation: Alewijnse D, Mesters I, Metsemakers J, van den Borne B. Predictors of long-term adherence to pelvic floor muscle exercise therapy among women with urinary incontinence. Health Educ Res. 2003 Oct;18(5):511-24. doi: 10.1093/her/cyf043.
citation: Barber MD, Spino C, Janz NK, Brubaker L, Nygaard I, Nager CW, Wheeler TL; Pelvic Floor Disorders Network. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009 May;200(5):580.e1-7. doi: 10.1016/j.ajog.2009.02.007.
citation: Alas AN, Dunivan GC, Wieslander CK, Sevilla C, Barrera B, Rashid R, Maliski S, Eilber K, Rogers RG, Anger JT. Health Care Disparities Among English-Speaking and Spanish-Speaking Women With Pelvic Organ Prolapse at Public and Private Hospitals: What Are the Barriers? Female Pelvic Med Reconstr Surg. 2016 Nov/Dec;22(6):460-466. doi: 10.1097/SPV.0000000000000315.