Evaluation of Ureteral Stents in the Management of Stone Disease

The Washington University

Status: Terminated

Conditions: Urinary Tract Stones; Urinary Stones

Treatments: Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.

Study type: Interventional

Funder types: Other

Identifiers

NCT02211313

201205184

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Ureteral stent - soft, 6 French

Active Comparator group

Description:

Subjects randomized to soft stent, size 6 French

Treatment:

Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.

Ureteral stent - hydrophobic, 6 French

Active Comparator group

Description:

Subjects randomized to hydrophobic stent, size 6 French

Treatment:

Device: Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.