Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury (NBRG-PCORI)

November 3, 2021 updated by: Jeremy Myers, University of Utah
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1479

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Clean Intermittent Catheterization
Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel
Other: Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
Indwelling Catheter
Participants utilizing an Foley catheter or a suprapubic tube (cystostomy)
Other: 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)
Other: 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
Other: Voiding
Voiding spontaneously is a standard of care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Baseline and 1 year longitudinal follow up
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
Time Frame: Baseline and 1 year longitudinal follow up
The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact
Baseline and 1 year longitudinal follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NBSS Incontinence subdomain
Time Frame: Baseline and 1 year longitudinal follow up
The Incontinence subdomain measures degree of incontinence
Baseline and 1 year longitudinal follow up
NBSS Storage and Voiding subdomain
Time Frame: Baseline and 1 year longitudinal follow up
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
Time Frame: Baseline and 1 year longitudinal follow up
The Consequences subdomain measures bladder related complications
Baseline and 1 year longitudinal follow up
NBSS QoL Satisfaction
Time Frame: Baseline and 1 year longitudinal follow up
The final question of the NBSS assesses overall satisfaction with the urinary system
Baseline and 1 year longitudinal follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
University of Michigan
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeremy O Myers, MD, University of Utah School of Medicine - Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 82971

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings