Evaluation of Ureteral Stents in the Management of Stone Disease

Not Applicable

Terminated

• Conditions: Urinary Tract Stones; Urinary Stones
• Interventions: Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.

• Registration Number: NCT02211313
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-07
• Primary Completion: 2018-04-03
• Study Completion: 2018-04-03
• Results First Submitted: 2019-04-01
• Results First Submitted QC: 2019-04-30
• Status Verified: 2019-05
• Results First Posted: 2019-05-21
• Last Update Submitted: 2019-05-22
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ureteral stent - soft, 6 French	Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.	Subjects randomized to soft stent, size 6 French
Ureteral stent - hydrophobic, 6 French	Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.	Subjects randomized to hydrophobic stent, size 6 French

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States