Ureteral Stent Size Measurement Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by CAMC Health System
Sponsor:
Information provided by (Responsible Party):
Samuel Deem, DO, CAMC Health System
ClinicalTrials.gov Identifier:
NCT00919386
First received: May 15, 2009
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Phase
Quality of Life
Phase 4

Study Type: Observational
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?

Further study details as provided by CAMC Health System:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
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)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919386

Locations
United States, West Virginia
Urology center of charleston Recruiting
Charleston, West Virginia, United States, 25301
Contact: Samuel Deem, D.O.    304-388-5280    samuel.deem@camc.org   
Contact: Ryan Fitzwater, D.O.    304-388-1965      
Sub-Investigator: Fred Martinez, M.D.         
Sponsors and Collaborators
CAMC Health System
Investigators
Principal Investigator: Samuel Deem, M.D. CAMC Medical Staff - with admitting privileges
  More Information

No publications provided

Responsible Party: Samuel Deem, DO, Dr. Samuel Deem, CAMC medical Staff - With Admitting Privileges., CAMC Health System
ClinicalTrials.gov Identifier: NCT00919386     History of Changes
Other Study ID Numbers: 09-03-2137
Study First Received: May 15, 2009
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CAMC Health System:
Ureteric Measurement

ClinicalTrials.gov processed this record on August 18, 2014