Evaluation of Ureteral Stents in the Management of Stone Disease

NCT02211313 | Terminated Results

• 1 other identifier: 201205184
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, day 7 post stent removal

Study Arms (2)

Ureteral stent - soft, 6 French

ACTIVE COMPARATOR

Subjects randomized to soft stent, size 6 French

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

Ureteral stent - hydrophobic, 6 French

ACTIVE COMPARATOR

Subjects randomized to hydrophobic stent, size 6 French

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

Interventions

Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent. 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; Ureteral stent - soft, 6 French

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alana Desai, M.D.
• Organization: Washington University School of Medicine

desaia@wustl.edu

(314) 362-7581

Study Officials

• Alana C Desai, M.D.

  Washington UniversitySchool of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: June 5, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

US (1)