Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury (NBRG-PCORI)
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|ClinicalTrials.gov Identifier: NCT02616081|
Recruitment Status : Unknown
Verified January 2019 by Jeremy Myers, University of Utah.
Recruitment status was: Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Neurogenic Bladder Spinal Cord Injuries Quality of Life Incontinence||Other: Clean Intermittent Catheterization Other: Indwelling Catheter Other: Bladder Surgery|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
|Clean Intermittent Catheterization||
Other: Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
Other: Indwelling Catheter
Indwelling catheterization is a standard of care.
Other: Bladder Surgery
Bladder surgery is a standard of care.
- Patient reported QoL using the SCI-QoL and subdomains of SCI-QoL (physical, mental and social function) for three bladder management strategies: CIC, IDC, and bladder surgery. [ Time Frame: 1 year after enrollment ]
- Patient reported urinary specific bothers and complications with their Neurogenic Bladder Symptom Score for three bladder management strategies: CIC, IDC, and bladder surgery. [ Time Frame: 1 year after enrollment ]
- Complication rates and overall QoL (using the SCI-QoL) for three bladder management strategies: CIC, IDC, and bladder surgery. [ Time Frame: 1 year after enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616081
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|