Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
NBRG-PCORI
1 other identifier
observational
1,479
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedNovember 9, 2021
November 1, 2021
2.5 years
November 13, 2015
November 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
NBSS Incontinence subdomain
Baseline and 1 year longitudinal follow up
NBSS Storage and Voiding subdomain
Baseline and 1 year longitudinal follow up
NBSS Consequences subdomain
Baseline and 1 year longitudinal follow up
NBSS QoL Satisfaction
Baseline and 1 year longitudinal follow up
Study Arms (4)
Clean Intermittent Catheterization
Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel
Indwelling Catheter
Participants utilizing an Foley catheter or a suprapubic tube (cystostomy)
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)
Voiding
Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage
Interventions
Clean intermittent self catheterization is a standard of care.
Eligibility Criteria
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).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Patient-Centered Outcomes Research Institutecollaborator
- University of Minnesotacollaborator
- University of Michigancollaborator
Study Sites (3)
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Related Publications (2)
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.
PMID: 29017505RESULTCrescenze 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.
PMID: 33035138DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy O Myers, MD
University of Utah School of Medicine - Urology
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - School of Medicine
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 26, 2015
Study Start
January 1, 2016
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
November 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share