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Frost 2017
Frost 2017
Frost 2017
Frederick S. Frost
PII: S1934-1482(17)30697-4
DOI: 10.1016/j.pmrj.2017.06.022
Reference: PMRJ 1935
Please cite this article as: Frost FS, Failed Removal of Indwelling Urinary Catheters in Acute Stroke
Patients: Incidence and Risk Factors, PM&R (2017), doi: 10.1016/j.pmrj.2017.06.022.
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to
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3 Abstract
4 Background: Reducing the incidence of indwelling urinary catheter (IUC) use and early
5 removal of the devices that are inserted are appropriate priorities for quality patient
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6 care. Just like symptomatic bacteriuria, failed catheter removal as a complication of
7 IUC use is associated with considerable morbidity. In the ideal setting, patients that
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8 need IUCs have them, and patients that do not need them will have them safely
removed, with the goal of reducing medical complications and facilitating the
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9
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11 Objective: To determine the incidence of failed removal of indwelling urethral catheters
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12 (IUCs) and the factors associated with failed removal in persons hospitalized with acute
13 stroke.
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14 Design: Retrospective review of medical records and associated clinical data collection
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15 platforms.
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17 Patients: The study cohort included 175 stroke patients admitted to the hospital and
18 managed with IUCs. Mean age was 66.1 years (Standard Deviation = 15), 55% were
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19 female.
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21 Variables assessed included age, gender, race, duration of hospital stay, stroke
22 subtype, National Institutes of Health Stroke Scale and 6-Clicks Scale, which is a
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26 Results: Over the study period, 175 of 432 patients with acute hospital admission for
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27 new stroke had an IUC removal event. Of these patients, 46 (26%) experienced a failed
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29 removal included presence of a hemorrhagic stroke (p = .005), lower level of physical
function (by 6-Clicks and NIHSS scores), hospital length of stay (p < .001) and
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30
31 discharge location (p = .005). Bedside bladder ultrasound testing by nursing staff was
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32 more frequently utilized in the group of patients who had failed IUC removals (95%
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33 confidence interval: 4.561 - 21.669, p<.001). Length of stay (p < .001), white race (p =
34 .001), and hemorrhagic stroke (p = .009) were independently associated with failed
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36 Conclusions: This single site study identified a high incidence of failed urinary catheter
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37 removal in stroke patients, along with factors associated with failed removal. This is the
38 first step in developing a predictive model that could reduce the incidence of this
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39 adverse event. Policies, penalties and protocols designed to reduce catheter days must
40 be sensitive to the special situations where IUCs are medically necessary and equal
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41 consideration given to identifying the patients for which catheter removal poses a
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43
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44 Introduction
46 urinary tract infection (CAUTI), particularly since the Centers for Medicare and Medicaid
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47 Services (CMS) in the United States, in conjunction with the Center for Disease Control
48 (CDC), mandated financial penalties, such a 1% pay reduction, for hospitals linked to
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49 the diagnosis of urinary tract infection in catheterized hospital patients.1,2 While the use
of indwelling urinary catheters (IUCs) is a significant risk factor for the development of
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50
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52 a complex issue. 3,4 The IUCs are employed in the sickest hospital patients, and their
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53 presence serves as much as a marker for burden of illness as a predictor of subsequent
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54 complications.2 5,6 Urinary catheterization is commonly employed in patients with stroke,
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55 who often fulfill multiple criteria for their placement, such as bladder dysfunction and
critical illness (Table 1).7 The problem of failed IUC removal crosses venues of care, as
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57 patients move from acute care to rehabilitation settings, making it difficult to study.
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58 Management of failed IUC removal, defined as the need for IUC reinsertion, often
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62 and unnecessary use of these devices.8 Studies link catheter use with the development
2,6,9,10
64 growth has been directly linked to duration of catheter use. For some patients,
65 bacteriuria will cause symptomatic infection and even urosepsis.11 In general, reducing
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66 the incidence of IUC use and early removal of the device are thus appropriate priorities
5,12
67 for quality patient care. There are, however, subpopulations of patients for which
68 catheters should be left in place – short term and long term.13 Unlike an intravenous
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69 line, when the time to remove the device is heralded by the intake of oral fluids and
70 medications, the only way to determine whether the patient will be able to empty their
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71 bladder successfully after using an IUC is to remove the catheter.14
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72 This study aimed to identify risk factors for failed removal of IUCs in stroke
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74 IUC use is associated with considerable morbidity.3 Patients who cannot empty their
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75 bladder are prone to bladder over distension even under the most conscientious nursing
76 surveillance.15 Urine that is colonized with bacteria poses a much greater risk to the
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77 patient with high bladder pressures (when the patient experiences urinary retention)
than colonized urine under low pressure with an indwelling catheter.16 The detrusor
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damage brought about by an episode of bladder over distension can lead to re-insertion
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81 prolonged catheter use.17 Incontinence, especially in female patients who cannot use
82 external collecting devices (condom catheters), is a major risk factor for soft tissue
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84 setting.18,19 In the ideal setting, patients that need IUCs have them, and patients that
85 don’t need them will have them removed, with the goal of reducing medical
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88
89 Methods:
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91 Commission certified Comprehensive Stroke Center from August 2012 to April 2014.
92 Eligibility criteria included: (1) a first hospital admission during the study period with the
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93 principal diagnosis of ischemic or hemorrhagic stroke, (2) evaluation by physical
therapist as part of the hospital stroke carepath, (3) IUC inserted during current
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95 admission, and (4) evidence of an IUC removal event. Exclusion criteria included:
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96 patients who had a urinary catheter already in place at the time of current admission
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97 (e.g. nursing home patients with a chronic indwelling catheter), patients who died after
98 admission, and those patients for whom there was no attempt at IUC removal. Clinical
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99 data was obtained from review of the medical record. Administrative data and 6-Clicks
100 scores were electronically extracted from an institutional rehabilitation database. All
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101 patients were treated under a stroke care path that guides clinical decision and assists
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102 in adherence to processes that are considered standard of care.22 Under this care path,
103 physical therapy assessments are mandated by the third hospital day for all stroke
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104 patients except those that were critically ill or whose management focus was providing
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105 comfort care. The emphasis on detailing consistent measurement of global physical
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106 function in this study was related to an a priori assumption that such function is
107 associated with voiding success after catheter removal. No specific criteria or protocol
108 was in place to prompt IUC removal. IUC removal was carried out as part of clinical
109 judgment by nursing and medical staff, guided by the general catheter use concepts
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111 neurologic impairment and functional status are collected as part of standard practice
112 using National Institutes of Health Stroke Scale (NIHSS) and 6-Clicks scale. The
114 items with higher scores indicating greater impairment23. The 6-Clicks tool is a valid
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115 and reliable measure of basic mobility and self-care function that is used in the acute
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116 care setting to inform therapy resource utilization and discharge
117 recommendations.24,25,26 Scores on the 6-clicks tool are normalized along a 100 point
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118 scale, with mean = 50 and standard deviation (SD) = 10. Higher scores reflect lower
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120 Clinical characteristics were summarized using descriptive statistics. Univariate
121 analysis was first performed to separately evaluate the association of clinical factors
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122 with failed IUC removal. The need to replace an IUC was considered a failure. If the
123 patient had multiple attempts to remove the IUC, only the first event was counted.
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124 Univariate odds ratios with 95% confidence intervals were obtained using logistic
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125 regression.
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126 To evaluate the clinical factors independently associated with failed IUC removal,
127 multiple variable logistic regression models were constructed using forward stepwise
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128 variable selection. The dependent variable was failed removal of an IUC. The following
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129 variables were evaluated for inclusion: marital status (married, single, other) length of
130 hospital stay (days), stroke subtype (ischemic, hemorrhagic) and initial and final 6-
131 clicks and NIHSS scores. The significance level for entry into and exit from the model
132 was .15. The variables age (unit = 10 years), sex and race (white/non-white, ascribed
133 by the patient or family member, not by staff) were forced into the model regardless of
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134 their inclusion in the stepwise selection process. The Hosmer and Lemoshow
135 Goodness of Fit test was calculated to evaluate fit of the model. 2728 A separate model,
136 which included only the variables that were known before the IUC removal, was created
137 using similar methods. All analyses were conducted with SAS Version 9.4 (SAS
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138 Institute, NC). A significance level of alpha=.05 was applied.
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139
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140 Results:
141 During the 20-month time period of the study, 175 patients met eligibility criteria
142
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including attempt at IUC removal. Characteristics of the study cohort are described in
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143 Table 2. Mean age was 66.1 years (SD 15.1) and mean admission NIHSS was 12.8
144 (SD 8.1). Over half (55%) were female. Forty-six patients (26.3%) had an unsuccessful
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145 catheter removal. Factors available prior to IUC removal attempts that were associated
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146 with an unsuccessful removal on univariate analysis included white race (p = .020),
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147 hemorrhagic stroke (p = .005), and lower level of physical function as measured by
148 initial 6-Clicks score (p = .003) (Table 2). Additional factors associated with failed
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149 catheter removal that were only available at hospital discharge included total acute care
150 hospital length of stay (p < .001), worse discharge NIHSS Score (p = .015), and
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151 discharge to a destination other than home (p = .04, p = .002). Among patients who
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152 had a successful IUC removal, the average number of catheter days prior to successful
153 removal was 3.7 days (SD = 3.3). Among patients who had a failed IUC removal, the
154 average number of catheter days preceding the failed IUC removal was 3.8 days (SD =
155 4.5). These two averages were not significantly different (P = 0.92). As expected,
156 patients with failed IUC removal were more likely to have ultrasound scanning at the
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157 bedside following initial catheter removal in order to determine urine retention (OR 9.94,
159 Results of the multiple logistic regression (Table 3) demonstrate that the longer
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160 length of stay (p < .001), white race (p = .001) and hemorrhagic stroke (p = .009) were
161 independently associated with failed catheter removal. For the model limited to
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162 variables available at the time of the IUC removal, we found that initial 6-clicks score (p
= .003), white race (p = .006) and hemorrhagic stroke type (p = .005) were
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163
164 independently associated with a failed catheter removal. The Hosmer and Lemoshow
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165 Goodness of Fit test showed acceptable fit for both models (p = > .44 for either model).
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166
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167 Discussion:
168 Failed IUC removal was a common adverse event in our study of patients
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169 admitted to a Comprehensive Stroke Center. The push to reduce catheter days is based
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170 largely upon a self-evident concept that a foreign body in the bladder provides a “nidus
for infection”. In the medical literature, a handful of clinical studies propose that the
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171
172 catheter is the problem, although these studies have not controlled for the patient’s
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173 primary burden of illness and define urinary tract infections in variable ways.2 It has
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174 been well documented that urinary bacteria colonization is very common in older
175 patients, with or without catheters.29 In fact, the long held notion that normal urine is
176 sterile has recently been challenged as investigators reframe the concept of a normal
177 human microbial biome. Using bacterial DNA measurements and more sensitive
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179 taken from normal individuals.30,31 In all of our study patients, the catheter was placed
180 on the basis of physician admitting orders, either in the emergency department or
181 intensive care unit. It is impossible to determine retrospectively which patients would
182 have entered the hospital with substantial bacteriuria, or which patients would have
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183 developed clinically important levels of bacteriuria during their stay even if a catheter
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184 was not used. There was no other documentation
In the acute care setting, IUCs are used out of necessity, when better bladder
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185
186 emptying options are not practical (Table 1).32 Intermittent catheterization is not
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187 medically advisable in critically ill patients.32 Fluid intake and renal output is widely
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188 variable in critically ill patients, (heightening the risk of bladder over-distension in
189 patients who may not be able to void), and urine output must be accurately measured.
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190 Repeated instrumentation of the lower genitourinary tract is not a benign intervention;
191 intermittent catheterization heightens the risk of urethral trauma and may introduce
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192 debris and skin bacterial flora into the bladder. In men, condom catheters pose their
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193 own risks especially in older men with prostatic hypertrophy.33,34,35 Although the urine
194 collection bag hanging at the bedside may be full, the patient’s bladder may be full as
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195 well. A sedated, highly medicated, and cognitively impaired male patient may be simply
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196 “overflow voiding” through a condom catheter with very high bladder pressures and
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197 over-distension. The confused patient with a distended bladder may not use the
198 nursing call-light and attempt to climb out of bed to access the bathroom. In fact, most
199 falls in the hospital setting are associated with toileting concerns.36,37 These problems
200 can be mitigated somewhat by increased nursing attention and easy accessibility of
201 bladder ultrasound scanners, made available to the bedside nurses.38 In our study,
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202 utilization of bladder scanning was associated with failed IUC removal, indicating that
203 nursing staff used this technology as a method of identifying removal failures.39
204 In this retrospective study, we were not able to determine the reasons why
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205 catheters were reinserted. Use of electronic medical record nursing flow sheets gave
206 us precise information about removal and reinsertion, but this form of documentation
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207 lacked the narrative to explain the reasoning that went into the decision. Likewise,
physician documentation regarding the reasons for ordering catheter reinsertion was
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208
209 uniformly absent. It is our suspicion that most of the catheter reinsertions came as a
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210 result of failure to void and urinary retention – incontinence is usually managed by adult
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211 diapers. The diagnosis of urinary retention can be made clinically, without bladder
212 ultrasound measurement, so bladder scanning was not deemed an accurate marker for
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214 An episode of urinary retention is not a trivial matter, although more is known
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215 about the risk factors for failed trial without catheter (TWOC) after an episode of urinary
216 retention than the risk factors for failed catheter removal after an IUC insertion for
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217 medical reasons, like stroke. Risk factors for failed TWOC after an episode of acute
218 retention include age greater than 75 years, urine volume drained more than one liter,
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219 and a previous history of lower urinary tract symptoms.40 In their multicenter review,
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220 Emberton noted that trials of IUC removal at 3 days after an episode of urinary retention
221 were only successful 20-43% of the time.41 Patients who fail with catheter removal are
222 thus often subjected to an extended period of continued IUC use. Taking the catheter
223 out in a patient who cannot empty their bladder is likely to greatly increase the number
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224 of catheter days. Establishing accurate accounting and accountability for these
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227 reason for IUC use (Table 1). This indication is paradoxical, however. In most
228 instances, the diagnosis of retention can only be made if the catheter is removed. In
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229 this study, chart history was collected regarding pre-hospitalization use of bladder or
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230
231 patients with a history of prostate obstruction or voiding dysfunction prior to stroke.
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232 Prior use of these medications was not found to be associated with failed catheter
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233 removal in our study. Numbers were small in these categories, however, and a study
234 that included more patients may yield different results. Some clinicians advocate for
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235 patients be given alpha blocker medications prior to catheter removal to improve the
236 likelihood of successful voiding by reducing outlet resistance.42 Further study of this
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237 tactic would be helpful. Drugs used to reduce bladder outlet resistance may have an
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238 impact on blood pressure, a special concern for patients who have had a recent stroke.
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239 As death – coincident with removal of life support – was an exclusion criteria for
240 the study, none of the patients in this study had IUC placed for “comfort care”.
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241 Nonetheless, there are selected situations where IUCs may be the best compromise
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242 choice. For terminally ill patients, IUCs may ease the pain, inconvenience, and hygiene
243 issues related to uncontrolled voiding.43,44 In addition, certain patients with neurogenic
244 bladder may reasonably choose to employ a suprapubic catheter or IUC over the long
245 term.45 For these patients, especially those with impaired hand function unable to void
246 utilizing other methods, intermittent catheterization would require the engagement of a
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247 24 hour caregiver. An IUC offers the independence and freedom to work, attend
249 In our study, factors that were independently associated with failed IUC removal
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250 could be stratified into two categories. The first category consisted of factors that were
251 known prior to catheter removal and included white race, greater impairment in
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252 admission functional status (as measured by 6-Clicks scores) and intracerebral
hemorrhage (rather than ischemic infarct). The latter two factors may measure the same
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253
254 phenomenon. Patients with intracerebral bleeding are on the average more
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255 neurologically impaired than those with ischemic infarcts upon admission.47 Although
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256 mean Functional Independence Measure (FIM) score may not vary upon discharge from
257 the rehabilitation unit, a study by Kelly et al. showed a higher percent of ischemic stroke
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258 patients achieve a score consistent with functional independence than do patients with
260 and failure to void after IUC removal is intuitive. Micturition is a complex process, and
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261 involves integration of spinal reflexes with the central nervous system, especially the
263 neurological deficit, and a higher risk for neurological voiding dysfunction. In addition,
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264 successful voiding may also be contingent on the patient’s body positioning, and use of
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265 neuroactive medications may reduce voiding function or level of alertness. Patients with
266 more severe functional restrictions may be unable to trigger a void using a bedpan or
267 urinal.
268 The finding that those patients in the white race category were at higher risk for
269 IUC removal failure is difficult to explain but may be due to differences in unmeasured
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270 clinical characteristics. The number of patients in the study cohort with nonwhite race is
272 The second category consists of variables that were available after the catheter
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273 was removed. Variables in this category that were independently associated with failed
274 IUC removal were white race, hemorrhagic stroke, and longer lengths of stay and
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275 discharge destination. The length of stay factor may also represent a proxy for severity
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276 of functional impairment.
277 Once a failed removal occurs, there is little to do but reinsert the catheter, watch
278
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and wait – often waiting for an extended time while a mechanically-damaged distended
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279 bladder recovers.49 As a non-surgical condition, the patient may receive little attention
280 from urology consultants. These events discourage the patient and family, and the
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281 presence of an IUC becomes a source of fear for family members who are being asked
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282 to assist the patient after discharge home.49 Broadly defined, incontinence is a
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283 predictive factor for discharge to a nursing facility, rather than home. It is plausible that
284 the presence of a urinary catheter may impact decisions about discharge setting.
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285 The term “catheter associated urinary tract infection” (CAUTI) correctly states
286 what science has shown, that catheters are associated with bacteriuria at a level that
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287 meets an arbitrary definition of the term. In practice, the term has come to be
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288 understood as “catheter caused urinary tract infection”, even though cause and effect is
289 difficult to determine in a patient with acute medical illness. When financial penalties
290 are imposed in concert with clinical practice guidelines, it is not surprising that the
291 pendulum may swing to overly enthusiastic implementation of clinical protocols. In this
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292 setting, even patients who may meet criteria for exclusion from catheter removal may
294 Protocols designed to reduce catheter days must be sensitive to the special
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295 situations where IUCs are medically necessary and equal consideration given to
296 identifying the patients for which catheter removal poses a greater risk than continued
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297 catheter use. This point is difficult to emphasize in the setting of a quality management
narrative that is financially incentivized to focus on IUC removal. The problem may be
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298
299 underestimated, because many patients with failed IUC removal are quickly discharged
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300 to a rehabilitation facility. These facilities thus assume responsibility for catheter days at
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301 the upstream hospital. The chances of avoiding these adverse events will be improved
302 as we learn more about the clinical scenario and timing that would predict successful
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303 removal of the catheter. It is probable that delaying catheter removal in selected
305 professionals, adept at managing bowel and bladder care in patients with disabilities,
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306 can take an active role in the acute care setting by educating staff on the implications of
307 unsuccessful IUC removal. Acute care physicians may be unaware of the long-term
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309 Strengths of this study are the detailed clinical information available including
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310 patients’ functional status and medication for urination. Limitations of this study include
311 its sample size, lack of data on reasons for reinsertion, lack of follow up as patients
312 were discharged to a variety of post- acute venues, and its retrospective, single-site
313 design. The high incidence of catheter reinsertions found in this study emphasize the
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314 need for better chart documentation by physicians and nurses, detailing the thought
316 Conclusions:
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317 The failed removal of an IUC is a common and significant adverse medical event
318 that is potentially preventable. This study identified a high incidence of failed IUC
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319 removal, along with factors associated with failed removal in stroke patients. This is the
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320 first step in developing a predictive model that can be used to inform IUC removal
321 decisions, although many more observations than those included in this study will be
322
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needed. Given our findings, we believe larger, prospective multi-center studies are
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323 warranted.
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324
325 Acknowledgements: The authors thank Vinoth Ranganathan MS MBA, and Erica
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326 Yates BSN, for their support and advice on study implementation and manuscript
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327 preparation.
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51. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA (2009). Guideline for
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Prevention of Catheter-associated Urinary Tract Infections, 2009. Center For
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52. Gokula, RM, Smith MA, Hickner J. Emergency room staff education and use of a
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urinary catheter indication sheet improves appropriate use of Foley catheters.
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sheets-items/2014-08-04-2.html.
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Table 1
The patient is critically ill and accurate measurements of urine output are needed.
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The patient requires prolonged immobilization (e.g. spine fractures, polytrauma).
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o urological surgery patients
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o patients expected to receive large volume infusions during surgery
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The patient requires incontinence management in the setting of wound management.
N 175 46 129
Age, mean (SD) 66.1 (15.0) 65.9 (14.8) 66.1 (15.1) 0.99 (0.79, 1.24) † .92
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Gender, N (%)
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Race, N (%)
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White 133 (76.0%) 41 (89.1%) 92 (71.3%) Reference
Married 80 (45.7%)
mean (SD)
Medication for Urination, N (%) 7 (4.0%) 1 (2.2%) 6 (4.7%) 0.46 (0.02, 2.77) .47
IUC Days, median (IQR) 2 (1-4) 2 (1-5) 2 (1-4) 1.00 (0.91, 1.10) .96
Length of Stay, median (IQR) 9.0 (5.4-13.4) 13.3 (9.0-20.9) 7.6 (4.9-11.2) 1.14 (1.08, 1.21) < .001
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IRF 69 (39.4%) 18 (39.1%) 51 (39.5%)
4.74 (1.32, 30.37) § .04
SNF 62 (35.4%) 17 (37.0%) 45 (34.9%)
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Bladder Scan after IUC Removal, N
50 (28.6%) 29 (63.0%) 21 (16.3%) 9.94 (4.65, 22.23) < .001
(%)
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† - Odds ratio based on 10 year increase in age
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§ - IRF and SNF were combined into one group for the odds ratio
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IUC: Indwelling Urinary Catheter
Table 3. Multivariate analysis of factors associated with failed removal of indwelling urinary catheter
removal using forward stepwise selection where, initially, candidate predictors were all variables in
Table 2 (Model 1) or limited to variables known before catheter removal (Model 2).
Model 1 Model 2
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Odds Ratio (95% CI) p-value Odds Ratio (95% CI) p-value
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Age (per 10 years) 1.05 (0.79, 1.40) .74 0.86 (0.66, 1.10) .24
Male Gender (vs. Female) 0.78 (0.33, 1.79) .56 1.09 (0.51, 2.30) .83
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Non-White Race (vs. White) 0.11 (0.02, 0.36) .001 0.21 (0.06, 0.59) .006
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Ischemic)
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Length of Stay (per day) 1.18 (1.11, 1.27) < .001 -- --