SUPPORT Workbook for Urinary Incontinence

(SUPPORT Trial)

Recruiting at 1 trial location

Overseen By Tara Samsel, BS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Must not be taking: UI medications

Disqualifiers: Pelvic prolapse, Recurrent UTIs, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

Yes, if you are currently taking medications for urinary incontinence or lower urinary tract symptoms, you cannot participate in this trial.

What data supports the effectiveness of the SUPPORT treatment for urinary incontinence?

Research shows that a program combining pelvic floor muscle exercises and bladder training can reduce the frequency and severity of urinary incontinence episodes, improve quality of life, and decrease the cost of managing the condition. This suggests that similar structured programs, like the SUPPORT treatment, may also be effective. ^{1 2 3 4 5}

What makes the SUPPORT Workbook for Urinary Incontinence treatment unique?

The SUPPORT Workbook for Urinary Incontinence treatment is unique because it focuses on a comprehensive approach that includes behavioral strategies, lifestyle changes, and supportive care, rather than relying solely on medication or surgery. This program emphasizes prevention and healthy bladder habits, which are not typically the primary focus of standard treatments. ^{2 6 7 8 9}

Research Team

Kimberly Kenton, MD

Principal Investigator

University of Chicago

James Griffith, PhD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

Self-identify as Black or of Hispanic ethnicity

I am 18 years old or older.

I am somewhat bothered by urinary issues.

Exclusion Criteria

I am currently on medication for urinary issues or have had surgery for it.

My pelvic organs have dropped beyond the vaginal opening.

I have a bladder emptying problem and a urinary infection.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week, home-based SUPPORT program combining cognitive behavioral therapy, behavioral modifications, and home physical therapy exercises.

8 weeks

Self-directed with support from research staff

Follow-up

Participants are monitored for changes in urinary symptoms and other outcomes 8 and 16 weeks after SUPPORT program initiation.

8 weeks

2 visits (virtual or in-person)

Long-term Follow-up

Participants' urinary symptoms and program adherence are assessed 16 weeks after SUPPORT program initiation.

8 weeks

Treatment Details

Interventions

• SUPPORT program (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: SUPPORT workbook Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Findings from Research

The implementation of an evidence-based guideline for managing urinary incontinence in older adults successfully improved urinary outcome scores, demonstrating its efficacy in enhancing patient care.

The article highlights the challenges faced during the implementation process and the importance of overcoming barriers to effectively translate evidence into practice for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance improvement in practice: managing urinary incontinence in home health patients with the use of an evidence-based guideline. Egnatios, D., Dupree, L., Williams, C.[2010]

The newly developed incontinence care protocol significantly reduced the severity of incontinence-associated dermatitis (IAD) and the occurrence of pressure ulcers in 120 patients with bowel incontinence in intensive care units.

Patients using the protocol experienced less severe pressure ulcers compared to those receiving conventional care, indicating that this evidence-based approach can effectively manage skin complications related to incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adaptation and Evaluation of the Incontinence Care Protocol]. Park, KH., Choi, H.[2015]

In a study of 154 women with urge-predominant urinary incontinence, 81% adhered to pelvic-floor muscle exercises during a 10-week intervention, but long-term adherence dropped to only 32% after one year.

The main barriers to maintaining exercise included difficulty remembering to exercise and finding time, suggesting that strategies to improve these aspects could enhance long-term adherence to behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. Borello-France, D., Burgio, KL., Goode, PS., et al.[2021]

A standardized protocol for urinary incontinence was tested in 21 women's health care sites with 1474 participants, leading to significant improvements in the frequency and volume of incontinence episodes, as well as reduced self-management costs.

The program also enhanced the quality of life for women by decreasing the discomfort associated with incontinence and allowing them to engage more in activities like shopping and exercising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice. Sampselle, CM., Wyman, JF., Thomas, KK., et al.[2019]

A 4-week behavioral intervention program combining pelvic floor muscle exercises and bladder training significantly reduced urinary incontinence symptoms in 60 middle-aged women, with improvements in leakage frequency, amount, and overall quality of life.

The positive effects of the intervention persisted even after a follow-up period, indicating that the program not only provided immediate relief but also contributed to long-term improvements in psycho-social well-being related to urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a behavioral intervention program for urinary incontinence in a community setting. Oh, HS., Kim, MK., Seo, WS.[2019]

The updated guidelines from the Agency for Health Care Policy and Research (AHCPR) emphasize the management of chronic 'intractable' urinary incontinence (UI) and provide a comprehensive algorithm for selecting appropriate treatments, including behavioral, pharmacologic, and surgical options.

The guidelines introduce the concept of prevention and promote healthy bladder habits, along with specific interventions such as toileting assistance, dietary management, and environmental modifications to improve the quality of life for individuals suffering from UI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's new: the AHCPR guideline update on urinary incontinence. Newman, DK.[2007]

A study involving 1,474 women across 21 healthcare sites showed that a standardized protocol for urinary incontinence significantly reduced the frequency and volume of incontinence episodes, leading to improved quality of life.

The implementation of pelvic floor muscle and bladder training not only decreased the bother associated with incontinence but also encouraged women to engage in activities they previously avoided, supporting the protocol's effectiveness and potential for widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice. Association of Women's Health Obstetric and Neonatal Nurses. Sampselle, CM., Wyman, JF., Thomas, KK., et al.[2019]

This systematic review aims to evaluate the quality of clinical practice guidelines for urinary incontinence in adult women, using a rigorous assessment method (AGREE II) across multiple databases, which will enhance understanding of guideline development.

The findings from this study are expected to inform health professionals and policymakers about high-quality recommendations for managing urinary incontinence, potentially identifying areas needing further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical appraisal of clinical practice guidelines for treatment of urinary incontinence: Protocol for a systematic review. Smiles, FB., Mazzei, LG., Lopes, LC., et al.[2022]

In a preliminary study of 10 noninstitutionalized women with urinary incontinence, common self-care practices included regular toileting, adjusting fluid intake, exercising, weight loss, seeking medical help, and using protective measures.

All participants reported negative feelings about their condition, with half expressing embarrassment, highlighting the emotional impact of urinary incontinence and the need for supportive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care practices of women with urinary incontinence--a preliminary study. Klemm, LW., Creason, NS.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Performance improvement in practice: managing urinary incontinence in home health patients with the use of an evidence-based guideline. [2010]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

[Adaptation and Evaluation of the Incontinence Care Protocol]. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence to behavioral interventions for urge incontinence when combined with drug therapy: adherence rates, barriers, and predictors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of a behavioral intervention program for urinary incontinence in a community setting. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

What's new: the AHCPR guideline update on urinary incontinence. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Continence for women: a test of AWHONN's evidence-based protocol in clinical practice. Association of Women's Health Obstetric and Neonatal Nurses. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Critical appraisal of clinical practice guidelines for treatment of urinary incontinence: Protocol for a systematic review. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Self-care practices of women with urinary incontinence--a preliminary study. [2015]