Clinical trial NCT00919386: Ureteral Stent Size Measurement Study
Official title: Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: Ureteric Measurement
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community patients who present to Charleston area Medical Center (CAMC) or the private urology clinics of Drs. Davalos,Martinez,Tierney with the requirement of ureteral stent would be screened for possible enrillment in the study.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: within 4 weeks post-porcedure
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Urology center of charleston
state: West Virginia
Study officials:
affiliation: CAMC Medical Staff - with admitting privileges
name: Samuel Deem, M.D.
role: PRINCIPAL_INVESTIGATOR
References: