Evaluation of Ureteral Stents in the Management of Stone Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •cystoscopy with stent placement
- •ureteroscopy with intracorporeal lithotripsy
Exclusion Criteria
- •Patients with compromised urinary tract due to cancer (e.g. bladder tumor, ureteral obstruction from non-GU malignancy)
- •Patients requiring bilateral surgical stone management procedure
- •Patients with any single stone exceeding 1.5 cm
- •Patients with severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment
- •Any patient who is on anticholinergic medication at baseline
Arms & Interventions
Ureteral stent - hydrophobic, 6 French
Subjects randomized to hydrophobic stent, size 6 French
Intervention: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. (Device)
Ureteral stent - soft, 6 French
Subjects randomized to soft stent, size 6 French
Intervention: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. (Device)
Outcomes
Primary Outcomes
Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported