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Principal Investigator: Hussein Al-Khalidi
Organization: DUKE UNIVERSITY
Fiscal Year: 2024
Award: $1,680,466
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 during the original project period. 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 applications, the investigators will analyze the data from the STENTS study, interpret
findings, and disseminate findings through peer reviewed publications.
Terms: <0-11 years old><21+ years old><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><Booklets><Brochures><COVID-19><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><Fluid Therapy><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><Manuscripts><Measures><Medical><Medicine><Modification><Morbidity><Morbidity - disease rate><NIDDK><National Institute of Diabetes and Digestive and Kidney Diseases><Obstruction><Output><Pain><Painful><Pamphlets><Participant><Patient Care><Patient Care Delivery><Patient Recruitments><Patients><Pediatric Hospitals><Peer Review><Pennsylvania><Perioperative complication><Philadelphia><Plasma><Plasma Serum><Post-Operative><Postoperative><Postoperative Period><Preparation><Prevalence><Prevention><Problem Solving><Procedures><Prospective, cohort study><Protocol><Protocols documentation><Provider><Psychosocial Assessment and Care><Public Health><Publications><Questionnaires><Randomized><Recommendation><Recurrence><Recurrent><Recurrent disease><Regimen><Relapsed Disease><Renal Calculi><Renal Stone><Reporting><Research><Research Design><Research Institute><Research Personnel><Research Resources><Researchers><Resources><Reticuloendothelial System, Serum, Plasma><Safety><Sampling><Scientific Publication><Scientist><Sensory><Serum><Societies><Stents><Structure><Study Type><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-19><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><novel><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><study design><success><symptom association><symptom comorbidity><tactile sensation><therapy design><treatment arm><treatment design><urinary><urologic><urological><web site><webinar><website><youngster>