Trial · NCT03244189
Prevention of Urinary Stones With Hydration
NCT03244189, Not applicable, Completed, Duke University; results first posted 2025-08-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prevention of Urinary Stones With Hydration. Trials, record NCT03244189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03244189
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Urinary Stones With Hydration
- NCT number
- NCT03244189
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,658 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Urinary Stones
- Interventions
- Fluid prescription, Financial incentive, Structured Problem Solving
- First posted
- 2017-08-09
- Last updated
- 2026-06-25
- Results first posted
- 2025-08-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Symptomatic Stone Event | 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). |
| Secondary | Number of Participants With Asymptomatic Formation of New Stone | Up to approximately 24 months | |
| Secondary | Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension | Baseline through approximately 24 months | 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). |
| Secondary | Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension | Baseline through approximately 24 months | |
| Secondary | 24-hour Urine Total Volume | 6, 12, 18, and 24 months | |
| Secondary | Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS) | Baseline, 6, 12, 18, and 24 months | 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. |
| Other | Costs of Study Interventions and Treatments for USD During the Follow-up Period | Baseline through approximately 24 months | To estimate study intervention costs, we will use a tool specifically designed to estimate costs associated with patient-centered interventions (R01NR011873). The costs of medical resource use will be assigned based on payment schedules (e.g., Medicare). To incorporate potential differences in health-related quality of life experienced by participants in the cost-effectiveness analysis, health state utilities will be estimated from existing literature. Full details of the economic analysis will be specified in the Economic Statistical Analysis Plan. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Symptomatic Stone Event | Baseline through approximately 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Asymptomatic Formation of New Stone | Up to approximately 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension | Baseline through approximately 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension | Baseline through approximately 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 24-hour Urine Total Volume | 6, 12, 18, and 24 months | L/day | MEDIAN | |
| SECONDARY | Costs of Study Interventions and Treatments for USD During the Follow-up Period | Baseline through approximately 24 months | |||
| SECONDARY | Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS) | Baseline, 6, 12, 18, and 24 months | Participants with CASUS data available at each timepoint. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Symptomatic Stone Event | Intervention | 154 | Participants | ||
| Number of Participants With a Symptomatic Stone Event | Control | 165 | Participants | ||
| Number of Participants With Asymptomatic Formation of New Stone | Intervention | 82 | Participants | ||
| Number of Participants With Asymptomatic Formation of New Stone | Control | 83 | Participants | ||
| Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension | Intervention | 45 | Participants | ||
| Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension | Control | 32 | Participants | ||
| Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension | Intervention | 232 | Participants | ||
| Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension | Control | 236 | Participants | ||
| 24-hour Urine Total Volume | Intervention | 6 months | 1.81 | 95% Confidence Interval 1.30 to 2.38 | L/day |
| 24-hour Urine Total Volume | Control | 6 months | 1.58 | 95% Confidence Interval 1.10 to 2.18 | L/day |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention | 826 | |
| Overall Study | STARTED | Control | 832 | |
| Overall Study | COMPLETED | Intervention | 676 | |
| Overall Study | COMPLETED | Control | 691 | |
| Overall Study | NOT COMPLETED | Intervention | 150 | |
| Overall Study | NOT COMPLETED | Control | 141 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asymptomatic hyponatremia | Metabolism and nutrition disorders | Intervention | 12 | 826 | |
| other | Asymptomatic hyponatremia | Metabolism and nutrition disorders | Control | 2 | 832 | |
| serious | Hyponatremia requiring hospitalization | Metabolism and nutrition disorders | Intervention | 0 | 826 | |
| serious | Hyponatremia requiring hospitalization | Metabolism and nutrition disorders | Control | 0 | 832 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intervention | 0 | 826 |
| Total, all-cause mortality | Control | 2 | 832 |
| Total, other adverse events | Intervention | 12 | 826 |
| Total, other adverse events | Control | 2 | 832 |
| Total, serious adverse events | Intervention | 0 | 826 |
| Total, serious adverse events | Control | 0 | 832 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DK110988 | Urinary Stone Disease Research Network: Scientific Data Research Center | SCALES, CHARLES D; AL-KHALIDI, HUSSEIN | DUKE UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention vs Control: Number of Participants With a Symptomatic Stone Event | Trial comparisons |
| Intervention vs Control: Number of Participants With Symptomatic Stone Recurrence, Asymptomatic Stone Formation, or Increase of Existing Stone by ≥2 mm in Any Dimension | Trial comparisons |
| Intervention vs Control: Number of Participants With Growth of Existing Stone by ≥ 2 mm in Any Dimension | Trial comparisons |
| Intervention vs Control: Number of Participants With Asymptomatic Formation of New Stone | Trial comparisons |
| Intervention vs Control: deaths from any cause | Trial comparisons |
| Intervention vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03244189
GET https://conductscience.org/api/trials/v1/NCT03244189/results?page=2