Ureteral Stent Size Measurement Study

Quality of Life Clinical Trial

Official title:

Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919386
• Other study ID #: 09-03-2137
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: July 30, 2015
• Start date: April 2009
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: CAMC Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To examine a patient's quality of life using three methods for measuring stent size: (a) direct measurement, (b) patient height, and (c) a standardized formula. The intent of the study is to show if there is a difference in a patient's quality of life, postoperative symptoms, pain medication and anticholinergic use by using one of these specific methods for stent size determination. No method is interventional in this study.

Description:

Ureteral stent placement is common in Urologic practice and many studies have been done looking at factors to improve stent related symptoms, but few have used a validated questionnaire to assess these symptoms affect on quality of life.We plan to prospectively randomize patients to three separate techniques such as (a) direct measurement,(b) patient height, and (c) a standardized formula for the determination of stent size. Using a validated questionnaire, the Ureteral Stent Symptoms Questionnaire (USSQ), we will assess whether there is a difference in outcome measures such as patient quality of life, need for pain medications and anticholinergics, and in postoperative symptoms based on one of these techniques. The USSQ was developed by Joshi et al to assess the impact of health-related quality of life issues related to ureteral stents. Data from USSQ questionnaire will be collected 7-10 days post-operatively as well as 4 weeks post-op and then this will be aggregated for our outcome measures to determine which method of stent size give better outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients presenting to Charleston Area Medical Center between the ages of 18 and 90 years old who will undergo cytoscopy or ureteroscopy with ureteral stent placement will be eligible for the study.

Exclusion Criteria:

• Patients excluded from this study will be those who are less than 18 years of age, pregnant women, and patients who are septic on presentation, as well as patients who have had lower extremity amputations or are wheelchair bound.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
United States	Urology center of charleston	Charleston	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CAMC Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the difference in patient quality of life (QOL), post-op symptoms, and pain medication and anticholinergic use in patients who receive ureteral stents where size is determined by direct measurement, patient height,a standardized formula.		within 4 weeks post-porcedure	No