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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Spinal Cord Injuries; Quality of Life; Neurogenic Bladder; Incontinence

Treatments: Other: Surgery; Other: Clean Intermittent Catheterization; Other: Voiding; Other: Indwelling Catheter

Study type: Observational

Funder types: Other

Identifiers

NCT02616081

82971

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,479 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,479 participants in 4 patient groups

Clean Intermittent Catheterization

Description:

Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel

Treatment:

Other: Clean Intermittent Catheterization

Indwelling Catheter

Description:

Participants utilizing an Foley catheter or a suprapubic tube (cystostomy)

Treatment:

Other: Indwelling Catheter

Surgery

Description:

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)

Treatment:

Other: Surgery

Voiding

Description:

Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage

Treatment:

Other: Voiding