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Completed

NCT Number: NCT02616081

Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury

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.

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Key information

Conditions

Neurogenic Bladder Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clean Intermittent Catheterization

Other

Clean intermittent self catheterization is a standard of care.

Indwelling Catheter

Other

Indwelling catheterization is a standard of care.

SURGERY

Other

Bladder surgery is a standard of care.

Voiding

Other

Voiding spontaneously is a standard of care.

Primary outcomes

  1. Neurogenic Bladder Symptom Score (NBSS): comparing change in: CIC, IDC, Voiding, and Surgery

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and 1 year longitudinal follow up

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

Secondary outcomes

  1. NBSS Incontinence subdomain

    Time frame: Baseline and 1 year longitudinal follow up

    The Incontinence subdomain measures degree of incontinence

  2. NBSS Storage and Voiding subdomain

    Time frame: 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

    Time frame: Baseline and 1 year longitudinal follow up

    The Consequences subdomain measures bladder related complications

  4. NBSS QoL Satisfaction

    Time frame: Baseline and 1 year longitudinal follow up

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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

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

Registry information

Acronym: NBRG-PCORI

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2015
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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