Neurogenic BladderNBRG-PCORINCT02616081
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
An observational study of Neurogenic Bladder and Spinal Cord Injuries, run by University of Utah at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Bladder, Spinal Cord Injuries, Quality of Life
- What is being tested?
- Clean Intermittent Catheterization, Indwelling Catheter and Surgery
- How many people
- 1,479 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Minnesota
Minneapolis, Minnesota, 55455
University of Utah
Salt Lake City, Utah, 84132
About this study
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.
Read the detailed description
Our study is a longitudinal observational study between bladder management strategies, comparing outcomes measured by patient reported questionnaires.
- Being tested
- Clean Intermittent Catheterization, Indwelling Catheter, Surgery, Voiding
- Keywords
- Urinary Bladder, Neurogenic, Quality of Life, Spinal cord injury, incontinence, Bladder
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clean Intermittent CatheterizationOther
Clean intermittent self catheterization is a standard of care.
Indwelling CatheterOther
Indwelling catheterization is a standard of care.
SurgeryOther
Bladder surgery is a standard of care.
VoidingOther
Voiding spontaneously is a standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Clean Intermittent Catheterization | Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel Receives: Other: Clean Intermittent Catheterization | |
| Indwelling Catheter | Participants utilizing an Foley catheter or a suprapubic tube (cystostomy) Receives: Other: Indwelling Catheter | |
| 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) Receives: Other: Surgery | |
| Voiding | Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage Receives: Other: Voiding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery
The NBSS quantifies bladder symptoms
Measured: 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
Measured: 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
Measured: Baseline and 1 year longitudinal follow up
Secondary outcomes (4)
NBSS Incontinence subdomain
The Incontinence subdomain measures degree of incontinence
Measured: 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
Measured: Baseline and 1 year longitudinal follow up
NBSS Consequences subdomain
The Consequences subdomain measures bladder related complications
Measured: Baseline and 1 year longitudinal follow up
NBSS QoL Satisfaction
The final question of the NBSS assesses overall satisfaction with the urinary system
Measured: Baseline and 1 year longitudinal follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,479 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Minnesota, University of Michigan
- Responsible party
- Principal investigator, Jeremy Myers, University of Utah
- Investigators
- Jeremy O Myers, MD, Principal investigator, University of Utah School of Medicine - Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616081
- Sponsor's protocol ID
- 82971
- Acronym
- NBRG-PCORI
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2015
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29017505Crescenze 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.
PubMed 33035138
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02616081
- Acronym / sponsor ID
- NBRG-PCORI / 82971
- Keywords
- Urinary Bladder, Neurogenic, Quality of Life, Spinal cord injury, incontinence, Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,479 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of Minnesota, University of Michigan
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clean Intermittent Catheterization | – | Other: Clean Intermittent CatheterizationParticipants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel |
| Indwelling Catheter | – | Other: Indwelling CatheterParticipants utilizing an Foley catheter or a suprapubic tube (cystostomy) |
| Surgery | – | Other: SurgeryUndergoing 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 | – | Other: VoidingParticipants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clean Intermittent CatheterizationClean intermittent self catheterization is a standard of care. | Other | Clean Intermittent Catheterization |
| Indwelling CatheterIndwelling catheterization is a standard of care. | Other | Indwelling Catheter |
| SurgeryBladder surgery is a standard of care. | Other | Surgery |
| VoidingVoiding spontaneously is a standard of care. | Other | Voiding |
Primary outcome
Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery
Time frame: 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
Time frame: 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
Time frame: Baseline and 1 year longitudinal follow up
The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact
4 secondary outcomes
NBSS Incontinence subdomain
Time frame: Baseline and 1 year longitudinal follow up
NBSS Storage and Voiding subdomain
Time frame: Baseline and 1 year longitudinal follow up
NBSS Consequences subdomain
Time frame: Baseline and 1 year longitudinal follow up
NBSS QoL Satisfaction
Time frame: Baseline and 1 year longitudinal follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Results publication: PubMed 29017505Patel 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.
- Derived from this study: PubMed 33035138Crescenze 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.
- Neurogenic Bladder Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy O Myers, MD principal investigator
University of Utah School of Medicine - Urology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder and Spinal Cord Injuries, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery (time frame: Baseline and 1 year longitudinal follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02616081, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.