# Optimizing Fluid Therapy and Stent Management in Children and Adults with Nephrolithiasis

> **NIH NIH U01** · UT SOUTHWESTERN MEDICAL CENTER · 2020 · $704,141

## Abstract

Project Summary:
Urinary Stone Disease (USD) is an increasingly prevalent and highly recurrent condition associated with major
morbidity at a rising cost to society. Thus, improved management can significantly reduce its health burden.
Increasing fluid intake is recommended to all USD patients. However, knowledge gaps persist regarding the
impact of fluid therapy in preventing USD recurrence including the optimal urine volume, safety of fluid therapy,
effectiveness of strategies to achieve and maintain a high urine volume, and whether such strategies reduce
USD recurrence. Although ureteral stenting is routinely performed after urological procedures for USD to mitigate
peri-operative complications, stents cause significant patient discomfort. The causal mechanisms are only partly
understood, and use of new stent biomaterial and medications post-stenting only partly relieve these symptoms.
Limiting inflammation is one pathway to reduce stent-related discomfort. Based on current knowledge, we submit
the following hypotheses: 1. Compared to standard practice, a strategy achieving a higher urine volume by
combining counseling, frequent reminders, and fluid intake modification by feedback, safely reduces USD
recurrence. 2. Biological factors identify USD patients likely to develop stent-related symptoms, and oral
glucocorticoids reduce stent-related discomfort by mitigating inflammation. To test these hypotheses, we will
pursue the following objectives in a multi-center collaborative effort: Aim 1. We will compare USD progression in
patients randomized to standard care vs. achievement of a urine volume >2.5 L/day in adult and >30 ml/Kg/day
in pediatric USD patients. We will also assess the impact of a customized strategy [combining counseling,
frequent reminders (via mobile technology), and modification of fluid intake habits using feedback (from periodic
assessment of urine volume surrogates)] on preventing USD recurrence. Aim 2. We will evaluate USD patients
undergoing ureteral stent insertion at the time of unilateral ureteroscopy for USD and receiving standard-of-care
medications with pre-, and post-procedural psychometric testing to identify predictors of greater stent-related
symptoms. Based on the findings, we will randomize high risk patients to a 5-day methylprednisolone course or
matching placebo to determine whether methylprednisolone as an adjunctive therapy safely reduces stent-
related symptoms. Aim 3. We will collect blood, urine, DNA and stool from stone formers as a resource for USD
Research Network investigators and other researchers. To achieve these aims, this application will combine the
expertise of established USD researchers and clinicians with a large base of USD patients to participate in a
collaborative effort with other USD investigators with the ultimate aim of improving USD patient care.

## Key facts

- **NIH application ID:** 9997684
- **Project number:** 5U01DK110994-05
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** NAIM M MAALOUF
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $704,141
- **Award type:** 5
- **Project period:** 2016-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9997684

## Citation

> US National Institutes of Health, RePORTER application 9997684, Optimizing Fluid Therapy and Stent Management in Children and Adults with Nephrolithiasis (5U01DK110994-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9997684. Licensed CC0.

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