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

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT02616081
Collaborator
Patient-Centered Outcomes Research Institute (Other), University of Minnesota (Other), University of Michigan (Other)
1,479
3
29.9
493
16.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1479 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]

    The NBSS quantifies bladder symptoms

  2. The Spinal Cord Injury Quality of Life Measurement System Bladder Management Difficulties (SCI-QOL Difficulties): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]

    The SCI-QoL Difficulties assesses feelings and psychosocial impact of bladder symptoms

  3. The Spinal Cord Injury Quality of Life Measurement System Bladder Complications (SCI-QOL Complications): comparing change in: CIC, IDC, Voiding, and Surgery [Baseline and 1 year longitudinal follow up]

    The SCI-QoL Complications assesses degree of bladder complications their psychosocial impact

Secondary Outcome Measures

  1. NBSS Incontinence subdomain [Baseline and 1 year longitudinal follow up]

    The Incontinence subdomain measures degree of incontinence

  2. NBSS Storage and Voiding subdomain [Baseline and 1 year longitudinal follow up]

    The Storage and Voiding subdomain measures symptoms related to frequency and emptying of the bladder

  3. NBSS Consequences subdomain [Baseline and 1 year longitudinal follow up]

    The Consequences subdomain measures bladder related complications

  4. NBSS QoL Satisfaction [Baseline and 1 year longitudinal follow up]

    The final question of the NBSS assesses overall satisfaction with the urinary system

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109
2 University of Minnesota Minneapolis Minnesota United States 55455
3 University of Utah Salt Lake City Utah United States 84132

Sponsors and Collaborators

  • University of Utah
  • Patient-Centered Outcomes Research Institute
  • University of Minnesota
  • University of Michigan

Investigators

  • Principal Investigator: Jeremy O Myers, MD, University of Utah School of Medicine - Urology

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jeremy Myers, Associate Professor - School of Medicine, University of Utah
ClinicalTrials.gov Identifier:
NCT02616081
Other Study ID Numbers:
  • 82971
First Posted:
Nov 26, 2015
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jeremy Myers, Associate Professor - School of Medicine, University of Utah
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2021