Ureteral Stent Size Measurement Study

NCT00919386 | Completed

• 1 other identifier: 09-03-2137
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Ureteric Measurement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAMC Health System: lead

Study Sites (1)

Urology center of charleston

Charleston, West Virginia, 25301, United States

Location

Study Officials

• Samuel Deem, M.D.

  CAMC Medical Staff - with admitting privileges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Samuel Deem, CAMC medical Staff - With Admitting Privileges.

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: June 12, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

US (1)