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Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury (NBRG-PCORI)

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ClinicalTrials.gov Identifier: NCT02616081
Recruitment Status : Active, not recruiting
First Posted : November 26, 2015
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of Minnesota - Clinical and Translational Science Institute
University of Michigan
Information provided by (Responsible Party):
Jeremy Myers, University of Utah

Brief Summary:
The investigators goal is to create a better understanding of patient reported outcomes for bladder management strategies (clean intermittent catheterization (CIC), indwelling catheter (IDC) and bladder surgery.

Condition or disease Intervention/treatment
Neurogenic Bladder Spinal Cord Injuries Quality of Life Incontinence Other: Clean Intermittent Catheterization Other: Indwelling Catheter Other: Bladder Surgery

Detailed Description:
Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Clean Intermittent Catheterization Other: Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.

Indwelling Catheter Other: Indwelling Catheter
Indwelling catheterization is a standard of care.

Bladder Surgery Other: Bladder Surgery
Bladder surgery is a standard of care.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with neurogenic bladder with urinary issues and currently being managed by one/ any of various bladder management treatments (clean intermittent catheterization, indwelling catheter or bladder surgery).
Criteria

Inclusion Criteria:

  • Participants with spinal cord injury
  • Participants with neurogenic bladder
  • Participants must be undergoing or starting at least one of the following bladder management treatments at the time of enrollment. a) Clean intermittent catheterization (CIC) b) Have an indwelling catheter (IDC) c) Have undergone bladder surgery
  • Age 18 or older
  • Willingness and ability to comply with study engagement
  • Able to provide consent

Exclusion Criteria:

  • Patients will be excluded that do not have neurogenic bladder
  • Patients that belong to a vulnerable population (pregnant, prisoners, mentally handicapped, etc)
  • Patients less than 18 years of age

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
University of Utah
Patient-Centered Outcomes Research Institute
University of Minnesota - Clinical and Translational Science Institute
University of Michigan

Additional Information:
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Responsible Party: Jeremy Myers, Associate Professor - School of Medicine, University of Utah
ClinicalTrials.gov Identifier: NCT02616081     History of Changes
Other Study ID Numbers: 82971
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeremy Myers, University of Utah:
Urinary Bladder
Neurogenic
Quality of Life
Spinal cord injury
incontinence
Bladder
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms