Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Study Overview
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Brief Summary
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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.

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

Official Title
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Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Conditions
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Neurogenic Bladder, Spinal Cord Injuries, Quality of Life, Incontinence

Intervention / Treatment
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* Other: Clean Intermittent Catheterization
* Other: Indwelling Catheter
* Other: Surgery
* Other: Voiding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with acquired 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) Spontaneous voiding, and d) Have undergone bladder surgery Age 18 or older Willingness and ability to comply with study engagement Able to provide consent Exclusion Criteria: Degenerative spinal cord issues, such as multiple sclerosis, neuromuscular dysfunction Congenital spinal cord issues, such as spina bifida, myelomeningocele, or cerebral palsy Participants that belong to a vulnerable population (pregnant, prisoners, mentally handicapped, etc) Participants less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clean Intermittent Catheterization<br>Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel | Other: Clean Intermittent Catheterization<br>* Clean intermittent self catheterization is a standard of care.<br>|
| Indwelling Catheter<br>Participants utilizing an Foley catheter or a suprapubic tube (cystostomy) | Other: Indwelling Catheter<br>* Indwelling catheterization is a standard of care.<br>|
| Surgery<br>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<br>* Bladder surgery is a standard of care.<br>|
| Voiding<br>Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage | Other: Voiding<br>* Voiding spontaneously is a standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery | The NBSS quantifies bladder symptoms | Baseline and 1 year longitudinal follow up | 
| The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery | The SCI-QoL Difficulties assesses feelings and psychosocial impact of bladder symptoms | Baseline and 1 year longitudinal follow up | 
| The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery | The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact | Baseline and 1 year longitudinal follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NBSS Incontinence subdomain | The Incontinence subdomain measures degree of incontinence | Baseline and 1 year longitudinal follow up | 
| NBSS Storage and Voiding subdomain | The Storage and Voiding subdomain measures symptoms related to frequency and emptying of the bladder | Baseline and 1 year longitudinal follow up | 
| NBSS Consequences subdomain | The Consequences subdomain measures bladder related complications | Baseline and 1 year longitudinal follow up | 
| NBSS QoL Satisfaction | The final question of the NBSS assesses overall satisfaction with the urinary system | Baseline and 1 year longitudinal follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Bladder, Neurogenic, Quality of Life, Spinal cord injury, incontinence, Bladder