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Lack of further funding.
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A thin tube, called a ureteral stent, is inserted into the ureter and is commonly used as treatment of urinary stone disease. Stents are designed to help provide drainage of the kidney in the setting of an obstructing stone, or postoperative swelling of the ureter. Though their presence is only temporary, stents are associated with a significant amount of patient discomfort and bother, which can negatively impact overall satisfaction. Over the past decades, there have been refinements in stent technology and usage philosophy. Smaller and softer stents are now available for use in patients, though studies evaluating the relative benefits have been conflicting. The investigators aim to evaluate the effect of stent size and composition upon outcomes after the treatment of stone disease, including patient comfort and satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ureteral stent - soft, 6 French | Active Comparator | Subjects randomized to soft stent, size 6 French |
|
| Ureteral stent - hydrophobic, 6 French | Active Comparator | Subjects randomized to hydrophobic stent, size 6 French |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. | Device | Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale. | Baseline, day 7 post stent removal |
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Inclusion Criteria:
Over 18 years of age and willing and able to provide informed consent
Patients with current urinary stone disease, undergoing any of the following procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alana C Desai, M.D. | Washington UniversitySchool of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ureteral Stent - Soft, 6 French | Subjects randomized to soft stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
| FG001 | Ureteral Stent - Hydrophobic, 6 French | Subjects randomized to hydrophobic stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ureteral Stent - Soft, 6 French | Subjects randomized to soft stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale. | Posted | Mean | Standard Deviation | Scores on a scale 0-10 (Numeric) | Baseline, day 7 post stent removal |
|
From the time of the initial stent placement through the completion of the 7 day post stent removal questionnaires. The timeframe in which data was collected for adverse events was up to 27 days.
Participation in the study did not pose any risks to the participants beyond what was expected from the standard of care surgical stone management procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ureteral Stent - Soft, 6 French | Subjects randomized to soft stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alana Desai, M.D. | Washington University School of Medicine | (314) 362-7581 | desaia@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2017 | Apr 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| BG001 |
| Ureteral Stent - Hydrophobic, 6 French |
Subjects randomized to hydrophobic stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires. | Count of Participants | Participants |
|
| Region of Enrollment | 5 soft and 2 hydrophobic patients failed treatment. 1 soft and 1 hydrophobic patients have no follow up questionnaires. | Count of Participants | Participants |
|
Subjects randomized to hydrophobic stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Ureteral Stent - Hydrophobic, 6 French | Subjects randomized to hydrophobic stent, size 6 French Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.: Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |