Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02616081

Acronym

NBRG-PCORI

Enrollment

1479

Registered

2015-11-26

Start date

2016-01-01

Completion date

2018-06-30

Last updated

2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence, Neurogenic Bladder, Quality of Life, Spinal Cord Injuries

Keywords

Urinary Bladder, Neurogenic, Quality of Life, Spinal cord injury, incontinence, Bladder

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.

Detailed description

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

Interventions

OTHERClean Intermittent Catheterization

Clean intermittent self catheterization is a standard of care.

OTHERIndwelling Catheter

Indwelling catheterization is a standard of care.

OTHERSurgery

Bladder surgery is a standard of care.

OTHERVoiding

Voiding spontaneously is a standard of care.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026