# Urologic Management to Preserve Renal Function Protocol - Component C

> **NIH ALLCDC U01** · DUKE UNIVERSITY · 2020 · $20,500

## Abstract

ABSTRACT
The optimal urologic management of newborns and young children with spina bifida (SB) remains undefined.
It is intuitive that early assessment of the neuropathic bladder in children with the myelomeningocele (MMC)
form of SB by urodynamic testing and subsequent intervention for those at high risk for renal injury would be
beneficial, but little data exist to prove superiority over observation. The Urologic Management to Preserve
Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) study was conceived to closely
evaluate and follow newborns with MMC in order to preserve initial renal function and allow these children to
reach adulthood with the best possible renal and bladder outcomes. An iterative protocol was created to
prospectively follow these children for the first five years of life on a set protocol. The Duke Comprehensive
SB clinic was selected as one of the inaugural nine centers to enroll newborns into the study that was initiated
in 2014 due in part to the size and diversity of Duke’s SB population and in part due to the clinical and scientific
acumen of the pediatric urology team at Duke. Clinical-scientists at Duke have been instrumental in the
implementation, initial evaluation, analysis, and dissemination of this protocol; in addition, Duke’s urology team
has been heavily involved in SB activities, such as the Spina Bifida Association’s Professional Advisory
Council, demonstrating our commitment to improving the lives of individuals living with SB and of their families.
It is critical that the UMPIRE study be extended to continue to assess the currently enrolled children at Duke.
The initial plan for UMPIRE analyses was that the initial 5 years of the UMPIRE protocol would focus on early
bladder function and development of urinary tract infections. The second 5-year period will be focused on
bowel and bladder continence outcomes, while the third 5-year period will focus more on renal outcomes and
defining the most appropriate indications for urologic surgeries. Currently, no enrolled children have reached
five years of age, meaning that the analyses of the first 5-year block are thus far not yet complete. Continued
data ascertainment beyond five years of age and into school-aged years will allow UMPIRE researchers to
better determine the long-term benefits and possible risks of the protocol towards achieving positive health
outcomes for young children with SB. The primary aims for our continued participation in the UMPIRE study
are 1) to continue to collect longitudinal data on previous enrolled patients according to the protocol, 2)
continue to approach all infants with MMC who are 3 months old or younger for enrollment, and 3) continue the
leadership role of our clinical-scientists in the refinement of data collection, analysis of data, and dissemination
of findings. Specific newly proposed aims include demonstrating the reliability of the urodynamic categorization
used in the UMPIRE study, deter...

## Key facts

- **NIH application ID:** 9988307
- **Project number:** 5U01DD001276-02
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Jonathan C Routh
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2020
- **Award amount:** $20,500
- **Award type:** 5
- **Project period:** 2019-09-01 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9988307

## Citation

> US National Institutes of Health, RePORTER application 9988307, Urologic Management to Preserve Renal Function Protocol - Component C (5U01DD001276-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9988307. Licensed CC0.

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