Ureteral Stent Size Measurement Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by CAMC Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
CAMC Health System
ClinicalTrials.gov Identifier:
NCT00919386
First received: May 15, 2009
Last updated: December 22, 2009
Last verified: December 2009

May 15, 2009
December 22, 2009
April 2009
May 2010   (final data collection date for primary outcome 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. [ Time Frame: within 4 weeks post-porcedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00919386 on ClinicalTrials.gov Archive Site
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Ureteral Stent Size Measurement Study
Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting?

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

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.

Quality of Life
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
Yes
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United States
 
NCT00919386
09-03-2137
No
Dr.Davalos M.D., CAMC medical Staff - With Admitting Privileges
CAMC Health System
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Principal Investigator: Julio G. Davalos, M.D. CAMC Medical Staff - with admitting privileges
CAMC Health System
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP