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Principal Investigator: Hing Hung Henry Lai
Organization: WASHINGTON UNIVERSITY
Fiscal Year: 2024
Award: $474,999
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
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
effectiveness of strategies to achieve and maintain a high urine volume, and whether such strategies
reduce USD recurrence. The Prevention of Urinary Stones with Hydration (PUSH) study is a
randomized clinical trial investigating the impact of increased fluid intake and increased urine output
on the recurrence rate of USD in adults and children. In this study 1,642 participants will be
randomized to a control or intervention arm. Participants in both arms receive a “smart water bottle”.
The intervention arm involves an additional program of behavioral interventions, including financial
incentives, structured problem solving, and low touch interventions designed to improve adherence to
a prescribed fluid intake regimen. The primary endpoint is occurrence of a stone event during a two-
year observation period. The PUSH study is in its third year, and due to multiple challenges to
recruitment of study participants, follow-up of participants and data collection have not yet been
completed. Additional time is needed to ensure study completion and to accomplish all study goals.
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. The STudy to Enhance uNderstanding of sTent-associated Symptoms (STENTS)
is a prospective observational cohort study enrolling adolescents and adults undergoing
ureteroscopic intervention for ureteral and/or renal stones. Participants undergo detailed symptom
assessment using validated questionnaires, a psychosocial assessment, quantitative sensory testing
for evaluation of pain sensitization, and detailed collection of clinical and operative data.
Biospecimens (blood and urine) are being collected for future research. Recruitment to the STENTS
study and follow-up of the participants are expected to be completed on time. However, additional
time and resources are needed for analysis of collected study data. In Aim 1 of this application, the
investigators will continue and complete participant enrollment for the PUSH study, continue
biospecimen collection for the NIDDK Repository, analyze the data, and prepare and submit several
planned manuscripts related to the study hypotheses. In Aim 2 of this application, the investigators
will analyze the data from the STENTS studies, interpret findings, and disseminate findings through
peer reviewed publications.
Terms: <0-11 years old><21+ years old><Abscission><Active Follow-up><Address><Adherence><Adolescent><Adolescent Youth><Adult><Adult Human><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Biological><Blood><Blood Plasma><Blood Reticuloendothelial System><Blood Serum><COVID crisis><COVID epidemic><COVID pandemic><COVID-19><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><CV-19><Caring><Child><Child Youth><Childhood><Children (0-21)><Children's Hospital><Clinic><Clinical><Clinical Research><Clinical Study><Collection><Communities><Conditioning Therapy><Coronavirus Infectious Disease 2019><Data><Data Analyses><Data Analysis><Data Collection><Deposit><Deposition><Disease><Disorder><Effectiveness><Endocrinologist><Enrollment><Ensure><Event><Excision><Extirpation><Fluid Therapy><Follow-Up Studies><Followup Studies><Foundations><Funding><Future><Goals><Health><Health Care Utilization><Hydration><Hydration status><Hydrogen Oxide><Individual><Intake><Intervention><Intervention Strategies><Interview><Investigation><Investigators><Kidney><Kidney Calculi><Kidney Stones><Kidney Urinary System><Knowledge><Leanness><Lifting><Liquid substance><Lived experience><Lived experiences><Manuscripts><Measures><Medical><Medicine><Morbidity><Morbidity - disease rate><NIDDK><National Institute of Diabetes and Digestive and Kidney Diseases><Obstruction><Operative Procedures><Operative Surgical Procedures><Output><Pain><Painful><Participant><Patient Care><Patient Care Delivery><Patient Recruitments><Patients><Pediatric Hospitals><Peer Review><Pennsylvania><Perioperative complication><Philadelphia><Plasma><Plasma Serum><Preparation><Prevalence><Prevention><Problem Solving><Procedures><Prospective, cohort study><Psychosocial Assessment and Care><Public Health><Publications><Questionnaires><Randomized><Recommendation><Recurrence><Recurrent><Recurrent disease><Regimen><Relapsed Disease><Removal><Renal Calculi><Renal Stone><Reporting><Research><Research Design><Research Institute><Research Personnel><Research Resources><Researchers><Resources><Reticuloendothelial System, Serum, Plasma><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety><Sampling><Scientific Publication><Scientist><Sensory><Serum><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Societies><Stents><Structure><Study Type><Surgical><Surgical Interventions><Surgical Procedure><Surgical Removal><Symptoms><Texas><Thinness><Time><Touch><Touch sensation><Tube><Universities><Ureter><Ureteroscopy><Urinary Calculi><Urinary Stones><Urinary Tract Stones><Urine><Urolith><Urologist><Visit><Washington><Water><Whole Blood><active followup><adulthood><arm><assess effectiveness><associated symptom><behavior intervention><behavioral intervention><biologic><body fluid balance therapy><care for patients><care of patients><caring for patients><clinical center><co-morbid symptom><co-occuring symptom><cohort><comorbid symptom><concurrent symptom><cooccuring symptom><coronavirus disease 2019><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><coronavirus infectious disease-19><cost><data interpretation><depository><design><designing><determine effectiveness><effectiveness assessment><effectiveness evaluation><enroll><evaluate effectiveness><evaluation/testing><examine effectiveness><experience><financial incentive><financial reward><fluid><follow up><follow-up><followed up><followup><health care service use><health care service utilization><healthcare service use><healthcare service utilization><healthcare utilization><improved><innovate><innovation><innovative><insight><intervention arm><intervention design><interventional strategy><juvenile><juvenile human><kids><liquid><monetary incentive><multidisciplinary><observational cohort study><participant enrollment><participant recruitment><patient enrollment><pediatric><preparations><prevent><preventing><primary end point><primary endpoint><programs><prospective><psychosocial assessment><psychosocial care><psychosocial studies><psychosocial support><radiologist><randomisation><randomization><randomized, clinical trials><randomly assigned><recruit><renal><repository><resection><response><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><study design><success><surgery><symptom association><symptom comorbidity><tactile sensation><therapy design><treatment arm><treatment design><urinary><urologic><urological><youngster>