Urinary StonesPUSHNCT03244189
Prevention of Urinary Stones With Hydration
A study testing Fluid prescription, Financial incentive and Structured Problem Solving in people with Urinary Stones, run by Duke University at 8 sites in United States.
Trial summary
A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Urinary Stones
- What is being tested?
- Fluid prescription, Financial incentive and Structured Problem Solving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,658 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Oct 2017to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged ≥ 12 years
- At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:
- Stone passage
- Procedural intervention
- Radiographically or ultrasonographically confirmed stone with any of the following:
- Gross hematuria ii. Renal colic or atypical abdominal pain attributed to the stone, as determined by a treating provider iii. A clinical pattern of intermittent symptoms consistent with intermittent obstruction at the ureteropelvic junction, as determined by a treating provider
Show all 11Show fewer
- Low 24-hr urine volume
- ≥18 years old: <2.0 L/day
- <18 years old: <25 ml/Kg/day up to 2.0L/day
- Able to provide informed consent (parental permission for children)
- Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study-provided wireless enabled "smart" bottle
Who cannot join
- Spinal cord injury
- Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening.
- Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease
- Cystinuria
- Primary hyperoxaluria
- Primary xanthinuria
Show all 37Show fewer
- Primary hyperparathyroidism
- Sarcoidosis
- Medullary sponge kidney
- History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo-osmolality (serum osmolality <275 mosm/kg)
- Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses
- History of or current Crohn's disease, ulcerative colitis, short gut syndrome (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection), chronic diarrhea, or GI tract ostomy.
- History of malabsorptive (e.g., Roux-en-Y gastric bypass) or restrictive (e.g., sleeve gastrectomy) bariatric surgery procedures
- Congestive heart failure
- NYHA class II or greater, and/or ii. Hospital admission in the past year for heart failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR <30 ml/min/1.7 m2 over a 3-month period) i. For adults (age ≥18), we will use the CKD-Epi equation which requires the measurement of serum creatinine only. ii. For children (age <18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic syndrome (>3.5 grams of protein per 24 hours) g. Cirrhosis with ascites
- Women who are currently pregnant or planning pregnancy within 2 years.
- Renal transplant recipient
- Bedridden study participants (ECOG ≥ 3)
- Uncorrected anatomical obstruction of the urinary tract
- History of recurrent urinary tract infections (> 3 UTI/year proven by urine culture)
- Exclusions due to medication use:
- Chronic use of lithium
- Long-term glucocorticoid use (> 7.5 mg prednisone daily for > 30 days prior to enrollment)
- Intake of narcotic medication on a daily basis for >30 days prior to enrollment
- Supplemental Vitamin C (> 1 g daily)
- Individuals with stones that have developed after the initiation of medications that are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide), high dose vitamin C (> 1 g daily), high dose calcium supplementation (> 1,200 mg daily) AND who have discontinued or plan to discontinue these medications.
- Individuals with stones composed of medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir) AND who have discontinued or plan to discontinue these medications.
- Note: Individuals who are on long-term medications that increase the risk of stone disease, who cannot stop these medications due to other chronic conditions (e.g., HIV) and who may reduce their risk for stone recurrence through increased fluid intake, will be eligible to participate in the trial. Examples of these medications include:
- Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)
- Medications that may crystallize in the urine (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and nelfinavir).
- Study participants <2 yrs life expectancy
- Non-English Speakers
- History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- Anatomical urologic abnormalities including ileal conduits, horseshoe kidney, megaureter or solitary kidney.
- Psychiatric conditions impairing compliance with the study
- Vulnerable population (prisoner and/or cognitive impairment that the investigator feels will impact the study participant's ability to participate in the protocol)
- Individual who will be unable to participate in the protocol in the judgment of the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Children's Hospital
Dallas, Texas, 75390
University of Texas Southwestern
Dallas, Texas, 75390
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
Washington University, St. Louis
St Louis, Missouri, 63110
About this study
A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi-component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2-year period.
Read the detailed description
This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former.
Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.
- Conditions
- Urinary Stones
- Being tested
- Fluid prescription, Financial incentive, Structured Problem Solving
- Keywords
- Urinary Stone Disease, Kidney Stone, Urinary Calculi
- Medical subject headings
- Urinary Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid prescriptionBehavioural
The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.
Financial incentiveBehavioural
Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.
Structured Problem SolvingBehavioural
Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake. Receives: Behavioral: Fluid prescription; Behavioral: Financial incentive; Behavioral: Structured Problem Solving |
| Control | No intervention | Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Symptomatic Stone Event
Having a symptomatic stone event was defined as meeting any 1 of 2 criteria - stone passage or a procedural intervention for a stone (whether the stone was causing symptoms or not).
Measured: Baseline through approximately 24 months
Secondary outcomes (5)
Number of Participants With Asymptomatic Formation of New Stone
Measured: Up to approximately 24 months
Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension
Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan and ultrasound).
Measured: Baseline through approximately 24 months
Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension
Measured: Baseline through approximately 24 months
24-hour Urine Total Volume
Measured: 6, 12, 18, and 24 months
Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)
The CASUS is a tool used to assess lower urinary tract symptoms (LUTS) in individuals, providing a comprehensive evaluation of various urinary issues. It's designed to capture a wide range of symptoms, including storage, voiding, post-micturition, urgency, incontinence, and abnormal bladder sensations. The total score ranges from 0 to 38, where a higher score indicates greater urinary symptoms.
Measured: Baseline, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start4 Oct 2017
- Primary completion18 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary StonesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Scales, MD, MSHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244189
- Sponsor's protocol ID
- Pro00083271
- Other IDs
- 1U01DK110988
- Acronym
- PUSH
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2017
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data and samples, for subjects who consent to sharing, will be sent to the NIDDK Data and Biological Samples Repository following database lock.
Publications
Desai AC, Maalouf NM, Harper JD, Sivalingam S, Lieske JC, Lai HH, Reese PP, Wessells H, Yang H, Al-Khalidi HR, Kirkali Z, Tasian GE, Scales CD Jr; Urinary Stone Disease Network Investigators. Prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention. Lancet. 2026 Mar 21;407(10534):1171-1181. doi: 10.1016/S0140-6736(25)02637-6.
PubMed 41864748Wessells H, Lieske JC, Lai HH, Al-Khalidi HR, Desai AC, Harper JD, Kirkali Z, Maalouf NM, McCune R, Reese PP, Scales CD, Tasian GE; NIDDK Urinary Stone Disease Research Network. Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial. Urology. 2024 Dec;194:27-35. doi: 10.1016/j.urology.2024.08.026. Epub 2024 Sep 4.
PubMed 39242045Reese PP, Shah S, Funsten E, Amaral S, Audrain-McGovern J, Koepsell K, Wessells H, Harper JD, McCune R, Scales CD Jr, Kirkali Z, Maalouf NM, Lai HH, Desai AC, Al-Khalidi HR, Tasian GE. Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial. BMC Nephrol. 2024 May 28;25(1):183. doi: 10.1186/s12882-024-03605-y.
PubMed 38807063Scales CD Jr, Desai AC, Harper JD, Lai HH, Maalouf NM, Reese PP, Tasian GE, Al-Khalidi HR, Kirkali Z, Wessells H; Urinary Stone Disease Research Network. Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. Am J Kidney Dis. 2021 Jun;77(6):898-906.e1. doi: 10.1053/j.ajkd.2020.09.016. Epub 2020 Nov 16.
PubMed 33212205
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Urinary Stones With Hydration
- ClinicalTrials.gov ID
- NCT03244189
- Acronym / sponsor ID
- PUSH / Pro00083271
- Conditions
- Urinary Stones
- Keywords
- Urinary Stone Disease, Kidney Stone, Urinary Calculi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,658 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical trial to investigate the impact of increased fluid intake and increased urine output on the recurrence rate of urinary stone disease (USD) in adults and children. The primary aim of the trial is to determine whether a multi-component program of behavioral interventions to increase fluid intake will result in reduced risk of stone disease progression over a 2-year period.
Detailed description
This is a two arm randomized controlled trial that incorporates pragmatic features, an adaptable intervention, patient choice, and remote monitoring of fluid intake through a "smart" water bottle. The study period is 24 months and will enroll approximately 1642 participants. Randomization will be stratified within a study site by age (adult vs. adolescent) and first time vs. recurrent stone former.
Intervention and control arm study participants will receive a smart water bottle that records daily fluid consumption, usual care including guideline-based recommendations of adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Fluid prescription, Behavioral: Financial incentive, Behavioral: Structured Problem SolvingParticipants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake. |
| Control | No intervention | –Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Aged ≥ 12 years
- At least 1 symptomatic stone event (passage or procedural intervention) within 3 years prior to enrollment or a symptomatic stone event within 5 years if the patient also has new stone formation detected on imaging during the last 5 years. Symptomatic stone defined as any of the following:
- Low 24-hr urine volume
- Able to provide informed consent (parental permission for children)
- Owning and willing to use a smartphone or other device (e.g., tablet) compatible with the study-provided wireless enabled "smart" bottle
Key exclusion criteria (37 listed)
- Spinal cord injury
- Currently undergoing active treatment for cancer except basal cell skin cancer, or patients with a history of cancer who completed their initial therapy <1 year before screening.
- Known infectious (struvite), monogenic or other causes of stone disease for which therapies are likely to significantly alter course of stone disease
- History or presence of hyponatremia (serum sodium <130 mmol/L) or hypo-osmolality (serum osmolality <275 mosm/kg)
- Study participants with comorbidities that preclude high fluid intake or prior surgery precluding high fluid intake or leading to GI fluid losses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid prescriptionThe additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day. | Behavioural | Intervention |
| Financial incentiveParticipants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day. | Behavioural | Intervention |
| Structured Problem SolvingStructure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake. | Behavioural | Intervention |
Primary outcome
Number of Participants With a Symptomatic Stone Event
Time frame: Baseline through approximately 24 months
Having a symptomatic stone event was defined as meeting any 1 of 2 criteria - stone passage or a procedural intervention for a stone (whether the stone was causing symptoms or not).
5 secondary outcomes
Number of Participants With Asymptomatic Formation of New Stone
Time frame: Up to approximately 24 months
Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension
Time frame: Baseline through approximately 24 months
Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension
Time frame: Baseline through approximately 24 months
24-hour Urine Total Volume
Time frame: 6, 12, 18, and 24 months
Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)
Time frame: Baseline, 6, 12, 18, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41864748Desai AC, Maalouf NM, Harper JD, Sivalingam S, Lieske JC, Lai HH, Reese PP, Wessells H, Yang H, Al-Khalidi HR, Kirkali Z, Tasian GE, Scales CD Jr; Urinary Stone Disease Network Investigators. Prevention of urinary stones with hydration: a randomised clinical trial of an adherence intervention. Lancet. 2026 Mar 21;407(10534):1171-1181. doi: 10.1016/S0140-6736(25)02637-6.
- Derived from this study: PubMed 39242045Wessells H, Lieske JC, Lai HH, Al-Khalidi HR, Desai AC, Harper JD, Kirkali Z, Maalouf NM, McCune R, Reese PP, Scales CD, Tasian GE; NIDDK Urinary Stone Disease Research Network. Adjudication of Self-reported Symptomatic Stone Recurrence in the Prevention of Urinary Stones With Hydration Trial. Urology. 2024 Dec;194:27-35. doi: 10.1016/j.urology.2024.08.026. Epub 2024 Sep 4.
- Derived from this study: PubMed 38807063Reese PP, Shah S, Funsten E, Amaral S, Audrain-McGovern J, Koepsell K, Wessells H, Harper JD, McCune R, Scales CD Jr, Kirkali Z, Maalouf NM, Lai HH, Desai AC, Al-Khalidi HR, Tasian GE. Using structured problem solving to promote fluid consumption in the prevention of urinary stones with hydration (PUSH) trial. BMC Nephrol. 2024 May 28;25(1):183. doi: 10.1186/s12882-024-03605-y.
- Derived from this study: PubMed 33212205Scales CD Jr, Desai AC, Harper JD, Lai HH, Maalouf NM, Reese PP, Tasian GE, Al-Khalidi HR, Kirkali Z, Wessells H; Urinary Stone Disease Research Network. Prevention of Urinary Stones With Hydration (PUSH): Design and Rationale of a Clinical Trial. Am J Kidney Dis. 2021 Jun;77(6):898-906.e1. doi: 10.1053/j.ajkd.2020.09.016. Epub 2020 Nov 16.
- The Urinary Stone Disease Research Network (USDRN) website. The USDRN is the program conducting the PUSH study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data and samples, for subjects who consent to sharing, will be sent to the NIDDK Data and Biological Samples Repository following database lock.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Scales, MD, MSHS principal investigator
Duke University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid prescription, Financial incentive and Structured Problem Solving in people with Urinary Stones, run by Duke University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Symptomatic Stone Event (time frame: Baseline through approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.