Incontinence Management Tool for Spina Bifida

Overseen By Jeremy Koehlinger, MT, CCRP

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Significant cognitive impairment, recent procedures

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

Compensation: Varies

Number of Visits: 5

67 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on developing a tool for setting personal continence goals rather than changing current treatments.

What data supports the effectiveness of this treatment for managing incontinence in patients with spina bifida?

The research on sacral neuromodulation (SNM) shows it is effective and safe for treating bladder and bowel issues in patients with spina bifida, which suggests that similar approaches in the incontinence management tool could be beneficial. ^{1 2 3 4 5}

How is the Incontinence Management Tool for Spina Bifida treatment different from other treatments?

This treatment is unique because it focuses on creating a personalized goal-setting tool for managing incontinence in children with spina bifida, incorporating patient and family experiences to tailor the approach, unlike standard treatments that may not consider individual preferences and goals. ^{1 2 3 6 7}

What is the purpose of this trial?

This study aims to develop an innovative, interactive tool for joint use by spina bifida patients and their urologists to identify patients interested in addressing their urinary and fecal incontinence and establish continence goal(s) they would like to achieve. To date, no such tool exists for use by spina bifida patients or urologists. This represents a major paradigm shift in the urologic care of pediatric SB patients. It will give children and families a voice in setting their personal goals for urinary and fecal incontinence, rather than relying on physicians' traditional clinical targets (e.g., absence of urinary incontinence, 4-hour dry interval). These traditional views fail to reflect the full patient experience of their ailment by underestimating symptoms and prioritizing only the most severe. This study represents the first time that such a process will be formalized before initiating urological therapy in children with SB (Aim 2). Additionally, this tool may help rule out interventions with a low chance of achieving desired goals and allow for a recalibration of unrealistic goals. The app will be useful for any child, regardless of urinary and fecal incontinence treatment history or underlying bladder pathology, as it will help describe personalized clinical treatment goals based on urinary incontinence, a characteristic all these patients share. This study will also capture the health-related quality of life (HRQOL) impact of urinary and fecal incontinence improvement regardless of the treatment, whether behavioral, medical or surgical, many of which are available to patients regardless of age. A systematic therapeutic goal-setting tool will help in bringing precision medicine to the SB population.

Eligibility Criteria

This trial is for children aged 8-17 with spina bifida who experience urinary and fecal incontinence, are followed at Riley Hospital Pediatric Urology Clinic, have a legal guardian as their primary caregiver, possess normal to mildly impaired cognitive development, can read English, and plan to receive care at the clinic throughout the study. It excludes those with significant cognitive impairment or recent genitourinary/bowel procedures.

Inclusion Criteria

Patients with spina bifida

English language literacy

Intent to receive care at the Riley Pediatric Urology Clinic for the extent of the study

Exclusion Criteria

I had a surgery related to my urinary or bowel system in the last 4 weeks.

My child does not have significant cognitive issues affecting communication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exploration

Stakeholder group of children and adolescents with spina bifida engage in self-reporting and video documentation to identify patient-centered UI goals.

3 hours

1 visit (in-person)

Co-Design

Selected dyads participate in a co-design session to refine insights and generate solutions for a goal-setting tool.

2-4 hours

1 session (in-person)

Testing

Patient/caregiver dyads use the tool during a clinic visit and provide feedback through cognitive interviews.

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for goal attainment, UI, and HRQOL over a 12-month period after the app is introduced.

12 months

2 visits (in-person or virtual)

Treatment Details

Interventions

• Aim 2
• Phase One: Exploration
• Phase Three: Reflection
• Phase Two: Creation

Trial Overview The trial is developing an interactive tool that helps children with spina bifida and their urologists set personal goals for managing urinary and fecal incontinence. This tool aims to shift focus from traditional clinical targets to personalized patient experiences and quality of life improvements.

Participant Groups

Group I: Standard Care Experimental Treatment 3 Interventions

Standard of care arm

Group II: Intervention Arm Experimental Treatment 1 Intervention

Intervention arm

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Sacral neuromodulation (SNM) was found to be effective in treating neurogenic bladder and bowel dysfunction in 33 patients with spina bifida, achieving a success rate of approximately 69.7% during a 14-28 day experiential treatment period without complications.

Patients experienced significant improvements in urinary symptoms, such as reduced urgency and leakage, as well as enhanced urodynamic parameters, indicating that SNM can help prevent upper urinary tract damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. Chen, G., Wang, Y., Ying, X., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Building a prototype of a continence goal-selection tool for children with spina bifida: Patient, parental and urology provider recommendations. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A patient- and parent-centered approach to urinary and fecal incontinence in children and adolescents with spina bifida: understanding experiences in the context of other competing care issues. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Female Pelvic Medicine & Reconstructive Surgery (FPMRS) challenges on behalf of the collaborative research in pelvic surgery consortium (CoRPS): managing complicated cases series 2: management of urinary incontinence in a neurogenic patient. [2020]

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

A multicenter evaluation of urinary incontinence management and outcome in spina bifida. [2006]

5. China pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of sacral neuromodulation on neurogenic bladder and bowel dysfunction in patients with spina bifida]. [2022]

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

Decision-making for a successful bowel continence program. [2004]

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

The feasibility of using ecological momentary assessment to understand urinary and fecal incontinence experiences in adults with spina bifida: A 30-day study. [2023]