Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04715971 |
| Other study ID # |
mp08305 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2015 |
| Est. completion date |
December 18, 2015 |
Study information
| Verified date |
January 2021 |
| Source |
Universitaire Ziekenhuizen Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Aim: The aim of this observational cohort study was to measure the prevalence of UR in
patients aged ≥75 years on admission to an acute geriatric hospitalisation unit and to
determine which at risk group would benefit from screening.
Methods: Post-void residual volumes (PVR) were measured within 3 days of admission with an
ultrasound bladder scan. Uni- and multivariable analysis were used to determine risk factors
associated with PVR ≥150 and ≥300 millilitres.
Description:
1. Sample and setting An observational cross-sectional cohort study was conducted on the
acute geriatric hospitalisation units of the University Hospitals Leuven in Belgium
which have a collective capacity of 80 beds. All patients aged 75 years or older
admitted with or without an indwelling urinary catheter between October 26 and December
18, 2015 were consecutively screened for inclusion within 72 hours of admission.
Patients with urinary catheters for any other reason than UR, patients with ascites,
dialysis, uro- or nephrostomy, terminally ill patients, and postoperative patients were
not eligible for inclusion. Patients who refused to participate, who were unable to
understand and carry out the instructions for the PVR measurement, with a urinary
catheter for chronic UR, who were discharged or died during the inclusion process were
excluded. The study was approved by the Ethics Committee Research of the University
Hospitals Leuven (mp08305). The study nurse (SV) obtained a written informed consent
from all patients who agreed to participate in the study, or from a proxy when the
patient was incapable to provide written informed consent.
2. Procedures Prior to the start of the study, information sessions were organised for the
nurses from the acute geriatric hospitalisation units, in which the study nurse (SV)
explained the aim of the study and the data collection procedure. In addition,
information was given on the use of the portable ultrasound bladder scan and the
execution of a bladder scan.
The nurses were asked to perform 3 consecutive post-void bladder scans as soon as
possible after admission and at the latest within 72 hours of admission as standard of
care during the study period. The highest value of the 3 consecutive PVR measurements
was recorded. The study nurse (SV) was present on Monday, Wednesday and Friday morning,
performed informed consents and performed bladder scanning in patients where this had
not yet been done. Before performing the bladder scan, the patients were asked to
urinate. Whenever possible, patients had to walk to the toilet in the bathroom, with or
without assistance, meanwhile their mobility was assessed.
Consecutively, the study nurse performed a bedside assessment. A mini-cog examination
was performed and urinary symptoms, defaecation habits, and fall history were assessed
by patient or caregiver interview using a structured questionnaire (SV). The demographic
and remaining clinical data were collected from the patient's electronic medical records
(SV, KH, KF).
3. Variables Outcome variables The PVR was measured using a portable ultrasound bladder
scan (Verathon BladdersScan BVI 3000). Jalbani et al. found a high correlation (r²=0.97)
between urinary catheterisation (gold standard) and bladder scanning and concluded that
the use of the Verathon BladderScan BVI 3000 is as accurate as urinary catheterisations
for measuring the PVR. As there are no official definitions or guidelines on what is
considered a relevant PVR for UR, in this study we defined UR as a PVR of ≥150
millilitres. In addition, we also included a PVR ≥300 ml as secondary outcome. The
cut-offs were chosen for the following reasons: the first bladder-filling sensation is
felt at a volume of 150 ml. At a volume of 300 ml, the pressure receptors in the bladder
wall will be activated, which creates a sense of fullness of the bladder and a need to
urinate. Moreover, in clinical practice a PVR ≥300ml is often considered as threshold
for insertion of a urinary catheter.
Demographics The following patient characteristics were recorded: age, gender and living
situation. Patients living alone at home and together at home were considered as living
at home and patients living in an assisted living facility or nursing home were
considered as not living at home. Patients living in a convent were considered as not
living at home when they were functionally or cognitively impaired.
Comorbidities Various comorbidities were retrospectively retrieved from the patient's
electronic medical records: neurological, gynaecological and urological history, a
history of diabetes type 1 or 2, recurrent falls (more than 1 fall episode in the last 6
months), and chronic kidney disease (CKD). CKD was defined as a glomerular filtration
rate (eGFR, calculated using the CKD-EPI formula) of <60 ml/min/1.73 m². An age adjusted
definition (<45 ml/min/1.73 m²) was also considered.
Clinical evaluation Urinary incontinence was assessed by means of 3 questions: Do you
have/does the patient have (1) an urge to urinate and involuntary loss of urine before
reaching the toilet? (2) involuntary loss of urine when sneezing, coughing, lifting or
moving something? (3) loss of small amounts or drops of urine without urge to urinate or
loss of small drops of urine when changing position. Answering positive on these
questions was classified as urge, stress or overflow incontinence, respectively. Dysuria
was questioned as having a burning sensation or pain when urinating. Urinary frequency
was questioned as urinating more often than usual. Voiding difficulty was questioned as
straining to void. Subtotal voiding was questioned as the feeling of incomplete bladder
emptying. Hypogastric pain was questioned as pain in the lower abdomen.
Constipation was defined as the absence of stools for 3 or more days before the PVR
measurement, or if patients reported having had less than 3 stools in the last week with
a need to strain and mostly hard or lumpy stools, or if the patient had faecal
impaction. Faecal impaction was defined as a large mass of compacted faeces in the
rectum or colon on clinical or radiographical examination, that could not be
spontaneously evacuated.
The cognitive status of the patients was evaluated using the Mini-Cog. The Mini-Cog is a
brief cognitive test that involves an assessment of an older person's ability to
memorise three words, to draw a clock, and to recall the three words. Repeating only 1
or 2 of the 3 words and being unable to draw a clock correctly or not being able to
repeat any of the words was considered as cognitive impairment.
Mobility was assessed by walking to the bathroom and going to the toilet. All patients
were asked to urinate on the toilet prior to the PVR measurements. Patients were
considered mobile if they could walk back and forth to the toilet and if they were able
to stand up from the toilet independently. The use of mechanical aids was permitted.
Needing assistance from another person or not being able to walk was defined as impaired
mobility.
Laboratory evaluation and urinalysis The patient's renal function was evaluated by serum
creatinine level and eGFR (calculated using the CKD-EPI formula).
A urinary dipstick test was performed in all patients. In patients with positive
leucocyte esterase or positive nitrites on the dipstick test, further urinalysis was
performed. An automated leucocyte count of ≥10 leukocytes/mm³ and significant
microscopic bacteriuria of >100.000 CFU/ml for which antibiotics were started by the
treating physician was considered as UTI in this study. If the patient was taking
antibiotics at the time of the urine sample and cultures remained negative, the presence
of UTI was determined based on the leucocyte count.
Medication For each patient the anticholinergic burden scale (ACB) score was calculated
taking into account medication use in the last 24 hours before the PVR measurement.
Individual drugs with high anticholinergic properties (ACB score ≥2), such as
antipsychotics, antidepressants, as well as detrusor relaxants, were examined separately
for their associations with UR. Antiepileptics, histamine H1 receptor antagonists,
anti-diarrhoea medications, decongestive drugs, spasmolytics, muscle relaxants, and
antiparkinsonian agents with ACB scores ≥2 were not considered individually. Low
prevalence of these drugs prohibited statistical analysis.
Reason for referral to the hospital The reasons for referral to the hospital were
divided into the following categories: confusion, falls or immobility, urinary symptoms,
cardiopulmonary symptoms, digestive symptoms, fever or non-specific symptoms with
biochemical inflammation (elevated leucocytosis and elevated C-reactive protein) on
admission, other. In patients with multiple reasons for admission, each reason was
scored separately.
4. Statistical analysis Descriptive and comparative statistics were used. Normally
distributed continuous variables were reported as means with standard deviations (SD).
Not normally distributed continuous variables were reported as medians with
interquartile ranges (IQR). Categorical variables were reported as numbers and
percentages. Baseline characteristics and clinical variables of patients with a PVR of
<150 ml versus ≥150 ml and a PVR of <300 ml versus ≥300 ml were compared using unpaired
t-tests for normally distributed continuous variables. Pearson Chi-squared tests or
Fisher's exact tests (if ≥1 cell had an expected count of less than 5) were used for
dichotomous or nominal variables, and Mann-Whitney U tests for not normally distributed
continuous variables or ordinal variables. All tests were 2-tailed, assuming a 5%
significance level. Multivariable logistic regression models were used to determine
independent predictors for a PVR ≥150 ml and a PVR ≥300 ml. Significant variables in the
univariable analysis were considered in a forward stepwise logistic regression
procedure. P-values (Likelihood ratios), odds ratios (OR), and 95% confidence intervals
(CI) are reported. The software package used was SPSS version 20 (SPSS Inc., Chicago,
IL).
