Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
NCT ID: NCT02616081
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1479 participants
OBSERVATIONAL
2016-01-01
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clean Intermittent Catheterization
Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel
Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
Indwelling Catheter
Participants utilizing an Foley catheter or a suprapubic tube (cystostomy)
Indwelling Catheter
Indwelling catheterization is a standard of care.
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)
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
Voiding
Voiding spontaneously is a standard of care.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
Indwelling Catheter
Indwelling catheterization is a standard of care.
Surgery
Bladder surgery is a standard of care.
Voiding
Voiding spontaneously is a standard of care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Patient-Centered Outcomes Research Institute
OTHER
University of Minnesota
OTHER
University of Michigan
OTHER
University of Utah
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeremy Myers
Associate Professor - School of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeremy O Myers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah School of Medicine - Urology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Utah
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Neurogenic Bladder Research Group
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
82971
Identifier Type: -
Identifier Source: org_study_id