Ureteral Stent Size Measurement Study
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 15, 2009 | ||||
| Last Updated Date | December 22, 2009 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00919386 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ureteral Stent Size Measurement Study | ||||
| Official Title ICMJE | Three Methods of Ureteral Stent Measurement: Which Method Improves Quality of Life After Ureteral Stenting? | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Quality of Life | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00919386 | ||||
| Other Study ID Numbers ICMJE | 09-03-2137 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr.Davalos M.D., CAMC medical Staff - With Admitting Privileges | ||||
| Study Sponsor ICMJE | CAMC Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | CAMC Health System | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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