Urinary Stones, Urinary Tract Stones
Conditions
Brief summary
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.
Interventions
DEVICERandomization 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years of age and willing and able to provide informed consent 2. Patients with current urinary stone disease, undergoing any of the following procedures: * cystoscopy with stent placement * ureteroscopy with intracorporeal lithotripsy
Exclusion criteria
1. Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy) 2. Patients requiring bilateral surgical stone management procedure 3. Patients with any single stone exceeding 1.5 cm 4. Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment 5. Any patient who is on anticholinergic medication at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 23 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No Follow up Questionnaires | 1 | 1 |
| Overall Study | Treatment Failure | 5 | 2 |
Baseline characteristics
| Characteristic | Ureteral Stent - Soft, 6 French | Ureteral Stent - Hydrophobic, 6 French | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 15 Participants | 21 Participants |
| Race/Ethnicity, Customized Race African American | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Caucasian | 12 Participants | 17 Participants | 29 Participants |
| Region of Enrollment United States | 12 Participants | 20 Participants | 32 Participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 19 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 20 |
| other Total, other adverse events | 0 / 12 | 0 / 20 |
| serious Total, serious adverse events | 0 / 12 | 0 / 20 |
Outcome results
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.
Time frame: Baseline, day 7 post stent removal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ureteral Stent - Soft, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | Pre Stent: Pain rating 0-10 (Numeric) | 1.3 Scores on a scale 0-10 (Numeric) | Standard Deviation 1.7 |
| Ureteral Stent - Soft, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | In-Situ: Pain rating 0-10 (Numeric) | 4.0 Scores on a scale 0-10 (Numeric) | Standard Deviation 3.5 |
| Ureteral Stent - Soft, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | Post: Pain rating 0-10 (Numeric) | 0.7 Scores on a scale 0-10 (Numeric) | Standard Deviation 1.1 |
| Ureteral Stent - Hydrophobic, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | Pre Stent: Pain rating 0-10 (Numeric) | 1.5 Scores on a scale 0-10 (Numeric) | Standard Deviation 2.3 |
| Ureteral Stent - Hydrophobic, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | In-Situ: Pain rating 0-10 (Numeric) | 4.8 Scores on a scale 0-10 (Numeric) | Standard Deviation 3.4 |
| Ureteral Stent - Hydrophobic, 6 French | Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal. | Post: Pain rating 0-10 (Numeric) | 1.1 Scores on a scale 0-10 (Numeric) | Standard Deviation 2.1 |