SUPPORT Workbook for Urinary Incontinence

(SUPPORT Trial)

Recruiting at 1 trial location

Overseen By Tara Samsel, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: UI medications

Disqualifiers: Pelvic prolapse, Recurrent UTIs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based program designed to help women manage urinary incontinence (UI) and lower urinary tract symptoms (LUTS) through education, exercises, and behavioral changes. Participants will use a workbook to guide them through therapy exercises and receive support from a specially trained computer program. The trial aims to evaluate the effectiveness and ease of use of the SUPPORT program for different women at home. Women who feel bothered by their UI symptoms and are willing to try a non-medical treatment for 16 weeks may be a good fit for this trial. As an unphased trial, this study offers women the opportunity to explore a new, non-medical approach to managing their symptoms in the comfort of their homes.

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 prior data suggests that the SUPPORT program is safe for women with LUTS/UI?

Research shows that conservative treatments for urinary incontinence, such as the SUPPORT program, are generally safe. A study on a similar digital care program for women with urinary incontinence found it practical and safe. Programs that combine education, exercises, and behavior techniques are usually well-received. The SUPPORT program includes self-guided exercises and cognitive behavioral therapy, which are non-invasive and carry a low risk of side effects. Although specific safety data for the SUPPORT program itself is not available, these types of treatments typically maintain a good safety record. Participants can feel confident about the general safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SUPPORT workbook for urinary incontinence because it combines traditional pelvic floor therapy techniques with innovative technology. Unlike standard treatments that typically involve in-person physical therapy sessions, the SUPPORT program provides patients with a workbook and access to a custom-trained GPT (a type of AI) that guides and supports them in performing exercises at home. This approach not only empowers patients with more flexibility and privacy in managing their condition but also incorporates empathetic communication techniques to enhance patient engagement. This hybrid method could revolutionize how patients receive care, making it more accessible and personalized.

What evidence suggests that the SUPPORT program is effective for urinary incontinence?

Research has shown that the SUPPORT program, which participants in this trial will receive, might help with urinary incontinence (UI). One study found that people experienced fewer urine leaks and improved quality of life even six months after treatment. Real-world evidence also supports the effectiveness and safety of digital health treatments for women with UI. Additionally, pelvic floor muscle exercises, included in the SUPPORT program, work equally well in groups and one-on-one sessions. These findings suggest that the SUPPORT program could effectively manage UI. ^{4 6 7 8 9}

Who Is on the Research Team?

Kimberly Kenton, MD

Principal Investigator

University of Chicago

James Griffith, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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 somewhat bothered by urinary issues.

I can easily communicate in English.

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 had multiple urinary tract infections.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SUPPORT program

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2599795/

Continence and Quality-of-Life Outcomes 6 Months ... Postintervention status was sustained at 6 months for all outcomes (mean [SD] urine leaks per week=1.2±2.1 versus 1.4±3.1; mean [SD] urine loss=0.2±0.5 g versus ...

2. formative.jmir.org formative.jmir.org/2024/1/e58551/

Real-World Evidence From a Digital Health Treatment ... This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI.

3. ahrq.gov ahrq.gov/evidencenow/projects/urinary/index.html

EvidenceNOW: Managing Urinary Incontinence More than half of women over 20 years of age reported any urinary leakage. Overall, about 30% of older women in the U.S. report moderate to severe UI, which can ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38935967/

Real-World Evidence From a Digital Health Treatment ... This study provides real-world evidence to support the effectiveness and safety of a prescribed digital health treatment program for female UI.

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2768776

Group-Based vs Individual Pelvic Floor Muscle Training to ... Results of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10285159/

Support of adult urinary incontinence products In the following chapters we provide further information on the safety evaluation of Always Urinary Incontinence products, post-market ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815799/

Digital Care Program for Urinary Incontinence in Females This study provides real-world evidence to support the feasibility and safety of this pelvic DCP to provide care to participants with UI.

8. journals.lww.com journals.lww.com/fpmrs/fulltext/2018/05000/twelve_month_efficacy_and_safety_data_for_the.5.aspx

Twelve-Month Efficacy and Safety Data for the “Stress ... The “Stress Incontinence Control, Efficacy and Safety Study” (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who ...

9. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003832

A Randomized Controlled Trial of a Web-Based ... Using adult- or child-specific language, the program asked 15 questions about the child's age, weight, frequency and severity of incontinence, ...