Ureteral Stent Size Measurement Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00919386

Enrollment

Registered

2009-06-12

Start date

2009-04-30

Completion date

2014-05-31

Last updated

2015-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Ureteric Measurement

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results