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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is developing a new tool to help children with spina bifida collaborate with their doctors to set personal goals for managing urinary and fecal incontinence. Unlike traditional methods that focus solely on medical targets, this tool involves patients in deciding which improvements matter most to them. It aims to enhance the quality of life for children who have experienced urinary or fecal incontinence in the past month and are followed at Riley Hospital Pediatric Urology Outpatient Clinic. The trial compares this new approach to standard care and welcomes children with normal to mild cognitive development who plan to continue receiving care at the clinic. As an unphased trial, it offers a unique opportunity for children to actively participate in shaping their own care and improving their quality of life.

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 prior data suggests that this tool is safe for spina bifida patients?

Research shows that recent studies have focused on creating a tool to help spina bifida patients manage incontinence. The National Spina Bifida Patient Registry gathers information on how patients handle their bowel and bladder issues, enhancing understanding of the challenges and outcomes for people with spina bifida.

Currently, specific information on the safety of the tool being developed in this study is unavailable. However, since this trial involves creating a non-invasive tool rather than a drug or surgery, there are no direct safety concerns such as side effects. This type of tool is typically easy to use because it doesn't involve medication or surgery. Instead, it assists patients in setting personal goals and improving their quality of life.

Overall, while the tool is new, its design suggests it will be safe to use. It focuses on improving communication between patients and doctors rather than introducing new medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new management tool for incontinence in individuals with spina bifida, focusing on a comprehensive approach rather than just medication or surgery. Unlike standard treatments that primarily involve medications like anticholinergics or surgical interventions, this tool aims to integrate phases of exploration, creation, and reflection to address incontinence more holistically. By incorporating patient feedback and adaptive strategies, it promises to offer a more personalized and potentially more effective solution. This innovative approach could lead to better quality of life outcomes by empowering patients with strategies tailored to their unique needs.

What evidence suggests that this tool is effective for managing incontinence in spina bifida patients?

Research has shown that managing urinary and bowel issues greatly improves the quality of life for people with spina bifida. In this trial, participants in the Intervention Arm will use a tool designed to help patients and doctors create personalized treatment plans, focusing on what is most important to the patient. Sacral neuromodulation, which uses gentle nerve stimulation, effectively treats bladder and bowel problems. About 80% of people with nerve-related bowel issues follow a program to help with constipation and bowel control, demonstrating that personalized management plans can be helpful. Evidence also suggests that setting personal goals for managing incontinence can lead to better satisfaction and results. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1477513125002955

Patient-reported outcome measures in Spina Bifida from ... 72 % used CIC, 48 % had urinary incontinence and 32 % had bowel incontinence. The Pediatric Global Health 7 (PGH-7) and Neurogenic Bladder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6660830/

Bowel management and continence in adults with spina ... We sought to 1) describe contemporary NBD management and continence outcomes of adults with SB; 2) describe differences from younger patients; and 3) assess for ...

3. spinabifidaassociation.org spinabifidaassociation.org/blog/quality-of-life-guideline/

Quality of Life Guideline Evidence consistently supports that bowel incontinence is associated with lower HRQOL and satisfaction with a bowel program is associated with ...

4. withpower.com withpower.com/trial/phase-spinal-dysraphism-11-2019-10142

Incontinence Management Tool for Spina Bifida Sacral neuromodulation (SNM) was found to be effective in treating neurogenic bladder and bowel dysfunction in 33 patients with spina bifida, achieving a ...

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/113684/cdc_113684_DS1.pdf

Neurogenic bowel treatments and continence outcomes in ... Of MMC individuals with NBD, 80% are on a management program for constipation and/or fecal continence [17,18]. The National Spina Bifida Patient ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11303588/

Data from the National Spina Bifida Patient Registry - PMC Comparing binary & ordinal definitions of urinary & stool continence outcomes: Data from the National Spina Bifida Patient Registry.

7. cdc.gov cdc.gov/spina-bifida/programs/index.html

Research and Tracking | Spina Bifida The NSBPR collects data on patient demographics, treatment, and outcomes (bowel and bladder continence, mobility, skin problems). Findings from the NSBPR can be ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03410667

Incontinence and Quality of Life in Children With Spina Bifida This study aims to develop an innovative, interactive tool for joint use by spina bifida patients and their urologists to identify patients interested in ...

9. stacks.cdc.gov stacks.cdc.gov/view/cdc/80103

Results from the National Spina Bifida Patient Registry ... We sought to 1) describe contemporary NBD management and continence outcomes of adults with SB; 2) describe differences from younger patients; and 3) assess for ...