Ureteral Stent Size Measurement Study
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?|
- 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. [ Time Frame: within 4 weeks post-porcedure ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
1 Direct ureteric measurement
This is determined by using a 5 French Pollack Open-Ended Flexi-Tip Ureteral catheter (Cook, Spencer, Indiana) to cannulate the ureteral orifice. A retrograde pyelogram will be done at the conclusion of the procedure and the Pollack will be advanced to the pyeloureteral junction (PUJ) under fluoroscopy. At this point the length of the distance between the PUJ and vesicoureteral junction (VUJ) will be recorded and stent length determined based on this measurement.
2 Based on patient height
We will use the height measurement criteria used by Lee et al in their study. Patients less than 5'2" will receive a 22 cm stent, 5'3"-5'7" will get a 24 cm stent, 5'8"-5'10" will get a 26 cm stent, 5'11" to 6'1" will get a 28 cm stent, and all patients greater than 6'2" will receive a 30 cm stent.
3 Based on a predetermined formula
We will use the formula described by Wieder. Stent length in cm= patients height in inches - 42.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919386
|United States, West Virginia|
|Urology center of charleston||Recruiting|
|Charleston, West Virginia, United States, 25301|
|Contact: Samuel Deem, D.O. 304-388-5280 firstname.lastname@example.org|
|Contact: Ryan Fitzwater, D.O. 304-388-1965|
|Sub-Investigator: Fred Martinez, M.D.|
|Principal Investigator:||Samuel Deem, M.D.||CAMC Medical Staff - with admitting privileges|