NBRG-PCORI: Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
Study Details
Study Description
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 | Phase |
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Detailed Description
Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Clean Intermittent Catheterization Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel |
Other: Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
|
Indwelling Catheter Participants utilizing an Foley catheter or a suprapubic tube (cystostomy) |
Other: Indwelling Catheter
Indwelling catheterization is a standard of care.
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Surgery Undergoing any of the following surgeries: augmentation cystoplasty with or without a catheterizable channel, creation of catheterizable channel alone, urinary diversion (conduit or continent catheterizable pouch) |
Other: Surgery
Bladder surgery is a standard of care.
|
Voiding Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage |
Other: Voiding
Voiding spontaneously is a standard of care.
|
Outcome Measures
Primary Outcome Measures
- Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]
The NBSS quantifies bladder symptoms
- The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]
The SCI-QoL Difficulties assesses feelings and psychosocial impact of bladder symptoms
- The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]
The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact
Secondary Outcome Measures
- NBSS Incontinence subdomain [Baseline and 1 year longitudinal follow up]
The Incontinence subdomain measures degree of incontinence
- NBSS Storage and Voiding subdomain [Baseline and 1 year longitudinal follow up]
The Storage and Voiding subdomain measures symptoms related to frequency and emptying of the bladder
- NBSS Consequences subdomain [Baseline and 1 year longitudinal follow up]
The Consequences subdomain measures bladder related complications
- NBSS QoL Satisfaction [Baseline and 1 year longitudinal follow up]
The final question of the NBSS assesses overall satisfaction with the urinary system
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants with acquired spinal cord injury
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Participants with neurogenic bladder
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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) Spontaneous voiding, and d) Have undergone bladder surgery
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Age 18 or older
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Willingness and ability to comply with study engagement
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Able to provide consent
Exclusion Criteria:
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Degenerative spinal cord issues, such as multiple sclerosis, neuromuscular dysfunction
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Congenital spinal cord issues, such as spina bifida, myelomeningocele, or cerebral palsy
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Participants that belong to a vulnerable population (pregnant, prisoners, mentally handicapped, etc)
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Participants less than 18 years of age
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
2 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
3 | University of Utah | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- University of Utah
- Patient-Centered Outcomes Research Institute
- University of Minnesota
- University of Michigan
Investigators
- Principal Investigator: Jeremy O Myers, MD, University of Utah School of Medicine - Urology
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 82971