# Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) at Texas Children's Hospital/Baylor College of Medicine

> **NIH ALLCDC U01** · BAYLOR COLLEGE OF MEDICINE · 2020 · $20,500

## Abstract

Project Summary
Spina bifida (SB) is the most common permanently disabling birth defect in children.1 In the United States alone, more
than 150,000 people live with SB and its long-term debilitating effects on multiple organ systems including the urinary
tract. For the urologic management of newborns with SB, preservation of the upper urinary tracts and thus avoiding
permanent loss of renal function via appropriate bladder management has been a key management goal for pediatric
urologists and SB healthcare providers.
Newborns with SB are generally placed on an observation protocol that includes serial urinary tract imaging and
urodynamics, as well as treatment options such as clean intermittent catheterization (CIC) and anticholinergic
medications. This promotes detrusor muscle relaxation and development by bladder cycling and ensures bladder
drainage in efforts to protect the upper urinary tract and prevent hydronephrosis.2 However, the outcomes of this
management are poorly documented, especially in patients who are presumed at low risk for renal damage, and there
is a lack of consensus on the timing of serial imaging/tests and the timing of when interventions such as CIC and
anticholinergics are introduced in SB management of the newborn. Moreover, prospective, longitudinal data for these
patients does not exist with respect to renal function, as well as, quality of life measures (e.g. urinary/fecal
incontinence), making evaluation of the efficacy of any management protocol difficult.
The long-term goal of this project is to improve the clinical management of pediatric patients with SB. The objective is to
continue implementation and evaluation of the Urologic Management to Preserve Initial Renal Function (UMPIRE)
Protocol for Young Children with Spina Bifida that was developed at the CDC, ultimately leading to a standardized
management protocol of efficient and effective urinary tract care in newborns and young children with SB that preserves
renal function for at least the first five years of life and beyond. Our central hypothesis is that this standardized
management protocol will establish effective clinical management that preserves long-term renal function, promote
efficient use of health care resources, and reduce the morbidity of current treatment algorithms. The rationale for the
proposed research is that research validated standardized management protocols in other clinical areas such as cystic
fibrosis and congenital heart conditions have improved clinical outcomes and cost effectiveness of healthcare
delivery.22,23 Texas Children's Hospital/Baylor College of Medicine has been a leading site for the UMPIRE protocol since
2015 testing the central hypothesis and coming closer to the objective of this proposal by pursuing the specific aim of
continued participation as a CDC registry site that will monitor and evaluate the UMPIRE Protocol for young children with SB.
Due to the large and unique population at our institution, enrollees to...

## Key facts

- **NIH application ID:** 9994099
- **Project number:** 5U01DD001263-02
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** Duong Dai Tu
- **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 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994099

## Citation

> US National Institutes of Health, RePORTER application 9994099, Urologic Management to Preserve Initial Renal Function Protocol for Young Children with Spina Bifida (UMPIRE) at Texas Children's Hospital/Baylor College of Medicine (5U01DD001263-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9994099. Licensed CC0.

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