Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Quality of Life Clinical Trial

— NBRG-PCORI  

Official title:

Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02616081
• Other study ID #: 82971
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: November 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1479
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Incontinence
• Neurogenic Bladder
• Quality of Life
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Wounds and Injuries

Intervention

Other:
• Clean Intermittent Catheterization
Clean intermittent self catheterization is a standard of care.
• Indwelling Catheter
Indwelling catheterization is a standard of care.
• Surgery
Bladder surgery is a standard of care.
• Voiding
Voiding spontaneously is a standard of care.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (4)

Lead Sponsor	Collaborator
University of Utah	Patient-Centered Outcomes Research Institute, University of Michigan, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

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

External Links

•   Neurogenic Bladder Research Group