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

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: Completed
• Conditions: Quality of Life; Spinal Cord Injuries; Neurogenic Bladder; Incontinence
• Intervention / Treatment: Other: Clean Intermittent Catheterization; Other: Indwelling Catheter; Other: Surgery; Other: Voiding

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 1479

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NBSS Incontinence subdomain	The Incontinence subdomain measures degree of incontinence	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	Baseline and 1 year longitudinal follow up
NBSS Consequences subdomain	The Consequences subdomain measures bladder related complications	Baseline and 1 year longitudinal follow up
NBSS QoL Satisfaction	The final question of the NBSS assesses overall satisfaction with the urinary system	Baseline and 1 year longitudinal follow up

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Patient-Centered Outcomes Research Institute; University of Michigan; University of Minnesota
• Investigators: Principal Investigator: Jeremy O Myers, MD, University of Utah School of Medicine - Urology

Publications and helpful links

General 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.
• 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.

Helpful Links

• Neurogenic Bladder Research Group

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Bladder; Spinal cord injury; incontinence; Neurogenic; Urinary Bladder
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID 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