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Patient-reported outcomes for bladder management strategies in spinal cord injury
Investigator (PI): Myers, Jeremy
Performing Organization (PO): (Current): University of Utah, School of Medicine, Department of Surgery, Division of Urology / (801) 581-7304
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2019
Record Source/Award ID: PCORI/CER-1409-21348
Funding: Total Award Amount: $2,793,180
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Nearly 80 percent of spinal cord injury (SCI) patients have urinary issues, like incontinence or increased frequency, which can place a significant burden on patients' physical health and quality of life (QoL). Inappropriate management can cause hospitalizations and serious complications, such as urinary tract infections and kidney damage. The gold standard for bladder management is clean intermittent catheterizations (CIC), where patients or caregivers perform regular urethral catheterization to empty the bladder; however, this task may be difficult for patients to perform independently due to physical limitations, or it's simply inconvenient. Alternatives include an indwelling catheter (IDC) that drains the bladder continuously or reconstructive surgery (to divert urine to a different location so patients can intermittently catheterize independently). However, each IDC and surgery has an increased risk of treatment-specific clinical complications compared with CIC. Patients believe that both independence and ability to carry out daily activities are just as important as physical health in selecting the right bladder management strategy. The research team agrees that patient-centered outcomes for CIC, IDC, or surgery in SCI patients will identify methods with the lowest complication rate, best QoL, and highest patient satisfaction. Understanding the impact on QoL--particularly on physical, mental, and social health--for these three bladder management methods, and the impact of urinary-specific complications using patient-reported outcomes is of particular interest for patients, caregivers, and clinicians. These factors are important for comprehensive QoL assessment among patients with SCI, as identified in previous studies and by our patient partners and stakeholders. This is a longitudinal observational study for three different bladder-management strategies for an estimated 910 to 1,370 SCI patients. Patients will be identified and recruited at (1) the University of Utah, (2) the University of Minnesota, and (3) the University of Michigan. To be eligible, a patient must have an SCI with urinary issues and be using one of the three bladder management treatments (CIC, IDC, or urinary diversion). We plan to use the Neuro-QoL developed for PROMIS, a computerized adaptive test questionnaire, to assess overall QoL, and the Neurogenic Bladder Symptom Score (NBSS) to capture the impact of urinary-specific issues and complications on QoL. The primary and secondary aims of this study are to compare total Neuro-QoL scores and total NBSS scores, respectively, across the three common bladder treatments. We will also compare scores for the subdomains of these surveys, which include physical, mental, and social function for the Neuro-QoL; and incontinence, storage and voiding symptoms, complications, and a QoL item for the NBSS. Additionally, we will determine whether complication rates for one of the three methods affect Neuro-QoL scores.
MeSH Terms:
  • Caregivers
  • Humans
  • Longitudinal Studies
  • Michigan
  • Minnesota
  • Multicenter Studies as Topic
  • * Outcome Assessment, Health Care
  • Patient-Centered Care
  • Quality of Life
  • Severity of Illness Index
  • Spinal Cord Injuries /complications
  • /*physiopathology
  • Universities
  • Urinary Incontinence /*complications
  • /therapy
  • Urination Disorders /*complications
  • /therapy
  • Utah
Country: United States
State: Utah
Zip Code: 84132
UI: 20153564
Project Status: Completed
Record History: ('2019: Project extended to 2019',)