Clinical trial NCT02616081: Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
Official title: Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Spinal Cord Injuries
Quality of Life
Incontinence
Keywords: Urinary Bladder
Neurogenic
Quality of Life
Spinal cord injury
incontinence
Bladder
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Minnesota
name: University of Michigan
First posted: 2015-11-26
Enrollment: 1479
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with neurogenic bladder with urinary issues and currently being managed by one/ any of various bladder management treatments (clean intermittent catheterization, indwelling catheter, voiding or bladder surgery).

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery
timeFrame: Baseline and 1 year longitudinal follow up
measure: The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery
timeFrame: Baseline and 1 year longitudinal follow up
measure: The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery
timeFrame: Baseline and 1 year longitudinal follow up
Secondary outcomes:
measure: NBSS Incontinence subdomain
timeFrame: Baseline and 1 year longitudinal follow up
measure: NBSS Storage and Voiding subdomain
timeFrame: Baseline and 1 year longitudinal follow up
measure: NBSS Consequences subdomain
timeFrame: Baseline and 1 year longitudinal follow up
measure: NBSS QoL Satisfaction
timeFrame: Baseline and 1 year longitudinal follow up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah School of Medicine - Urology
name: Jeremy O Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel DP, Lenherr SM, Stoffel JT, Elliott SP, Welk B, Presson AP, Jha A, Rosenbluth J, Myers JB; Neurogenic Bladder Research Group. Study protocol: patient reported outcomes for bladder management strategies in spinal cord injury. BMC Urol. 2017 Oct 10;17(1):95. doi: 10.1186/s12894-017-0286-3.
citation: Crescenze IM, Lenherr SM, Myers JB, Elliott SP, Welk B, O'Dell D, Stoffel JT. Self-Reported Urological Hospitalizations or Emergency Room Visits in a Contemporary Spinal Cord Injury Cohort. J Urol. 2021 Feb;205(2):477-482. doi: 10.1097/JU.0000000000001386. Epub 2020 Oct 9.