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Incontinence and Quality of Life in Children With Spina Bifida

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410667
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Konrad Szymanski, Indiana University

Brief Summary:
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. MyGoal 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.

Condition or disease Intervention/treatment Phase
Spina Bifida Myelomeningocele Behavioral: Phase One: Exploration Behavioral: Phase Two: Creation Behavioral: Phase Three: Reflection Behavioral: Aim 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Patient-centered Approach to Urinary Incontinence and Quality of Life in Children and Adolescents With Spina Bifida
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

Arm Intervention/treatment
Standard Care
Standard of care arm
Behavioral: Phase One: Exploration
Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.

Behavioral: Phase Two: Creation
Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.

Behavioral: Phase Three: Reflection
This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.

Experimental: Intervention Arm
Intervention arm
Behavioral: Aim 2
This will be a large scale validation of the tool.
Other Name: Prospective Assessment of Patient-Centered Goals and HRQOL




Primary Outcome Measures :
  1. UI Goal [ Time Frame: 5 years ]
    Goals and goal attainment will be assessed using the MyGoal tool. Patients who select a UI goal will be considered to be concerned about UI and offered UI treatments. Those who do not select a UI goal will be considered not to be concerned. Self-reported goal attainment will be categorized as: attained, not attained, and goal initially not identified.


Secondary Outcome Measures :
  1. General HRQOL (Kidscreen tool) [ Time Frame: 5 Years ]
    General HRQOL (secondary outcome) will be evaluated with the 27-item Kidscreen tool.83 All questionnaire scores range from 0 to 100, with higher scores indicating higher HRQOL. These data will serve as the basis for power calculations for future studies. [No additional patient-centered outcomes will be collected, so as not to overwhelm participants with lengthy questionnaires.]

  2. Dry Interval [ Time Frame: 5 year ]
    Self-reported UI will be assessed using clinically accepted criteria in SB care: a dry interval (<4h, ≥4h, always dry)

  3. Leak Amount [ Time Frame: 5 years ]
    Self-reported UI will be assessed using clinically accepted criteria in SB care: leak amount (a lot, medium, a little, none).

  4. SB-specific HRQOL [ Time Frame: 5 years ]
    The primary outcome, SB-specific HRQOL, will be evaluated using the validated 10-item QUAlity of Life ASsessment in Children/Teenagers (QUALAS-C/T).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spina bifida
  • 8-17 years old
  • Followed at Riley Hospital Pediatric Urology Outpatient Clinic
  • Primary caregiver is patient's legal guardian
  • Urinary incontinence in the past 4 weeks
  • Fecal incontinence in the past 4 weeks
  • Normal to mildly impaired cognitive development
  • English language literacy
  • Intent to receive care at the Riley Pediatric Urology Clinic for th extent of the study

The physician panel will be composed of pediatric urologists.

Exclusion Criteria:

  • Children with significant cognitive impairment, as they will not be able to express their urinary and fecal incontinence goals.
  • Patients who underwent a genitourinary procedure or a bowel procedure in the past 4 weeks, since these patients are often temporarily catheterized and therefore not experiencing their typical level of urinary and fecal incontinence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410667


Contacts
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Contact: Chantel M Colavecchia, MD 3172782478 ccolavec@iu.edu
Contact: Konrad Szymanski, MD, MHA (317) 948-4777 szymanko@iupui.edu

Locations
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United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Chantel Colavecchia    317-278-2478    ccolavec@iu.edu   
Sponsors and Collaborators
Indiana University
Additional Information:
Publications:
Elkoshy M, Szymanski KM, Morehouse D, Anidjar M, Andonian S. Shock-wave lithotripsy retreatment rates among three different lithotripters. UroToday Int. June 2012 2012;5(3):18.
Giacomin J. What Is Human Centred Design? The Design Journal. 2014/12/01 2014;17(4):606-623.
Sanematsu H, Wiehe S. Learning to look: Design in health services research. Touchpoint. 2014;July:TP06-02P82.
Jones JHC, Thornley DG. Conference on Design Methods. Oxford, New York,: Pergamon Press; 1963.
Sanematsu H, Wiehe S. How do you do? Design research methods and the
Sanematsu H. 53. Fun with Facebook: The Impact of Focus Groups on the Development of Awareness Campaigns for Adolescent Health. Journal of Adolescent Health. January 2011 2011;48(2):S44-S45.
Nielsen J. Estimating the number of subjects needed for a thinking aloud test. Int J Human-Computer Studies. 1994;41:385-397.
Stickdorn M, Schneider J. This is Service Design Thinking. Basics - Tools - Cases. Amsterdam: BIS Publishers; 2011.
Singer JD, Willett JB. Applied longitudinal data analysis : modeling change and event occurrence. Oxford ; New York: Oxford University Press; 2003.

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Responsible Party: Konrad Szymanski, Assistant Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT03410667    
Other Study ID Numbers: 1707207063
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities