Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

Completed

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

• Registration Number: NCT02616081
• Lead Sponsor: University of Utah

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-11-13
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2016-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1479

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indwelling Catheter	Indwelling Catheter	Participants utilizing an Foley catheter or a suprapubic tube (cystostomy)
Voiding	Voiding	Participants with volitional control, voiding into diapers or a condom catheter via crede, valsalva, or spontaneous leakage
Clean Intermittent Catheterization	Clean Intermittent Catheterization	Participants performing intermittent catheterization of their bladder, having not had augmentation cystoplasty or creation of a catheterizable channel
Surgery	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (3)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States