Evaluation of Ureteral Stents in the Management of Stone Disease

NCT ID: NCT02211313

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-04-03

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.

Conditions

Urinary Stones; Urinary Tract Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Ureteral stent - soft, 6 French

Subjects randomized to soft stent, size 6 French

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Ureteral stent - hydrophobic, 6 French

Subjects randomized to hydrophobic stent, size 6 French

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alana C Desai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington UniversitySchool of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201205184

Identifier Type: -

Identifier Source: org_study_id