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2016 ; 20
(7
): 1-150
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Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study
and economic evaluation
#MMPMID26806032
Rachaneni S
; McCooty S
; Middleton LJ
; Parker VL
; Daniels JP
; Coomarasamy A
; Verghese TS
; Balogun M
; Goranitis I
; Barton P
; Roberts TE
; Deeks JJ
; Latthe P
Health Technol Assess
2016[Jan]; 20
(7
): 1-150
PMID26806032
show ga
BACKGROUND: Urodynamics (UDS) has been considered the gold standard test for
detrusor overactivity (DO) in women with an overactive bladder (OAB). Bladder
ultrasonography to measure bladder wall thickness (BWT) is less invasive and has
been proposed as an alternative test. OBJECTIVES: To estimate the reliability,
reproducibility, accuracy and acceptability of BWT in women with OAB, measured by
ultrasonography, in the diagnosis of DO; to explore the role of UDS and its
impact on treatment outcomes; and to conduct an economic evaluation of
alternative care pathways. DESIGN: A cross-sectional test accuracy study.
SETTING: 22 UK hospitals. PARTICIPANTS: 687 women with OAB. METHODS: BWT was
measured using transvaginal ultrasonography, and DO was assessed using UDS, which
was performed blind to ultrasonographic findings. Intraobserver and interobserver
reproducibility were assessed by repeated measurements from scans in 37 and 57
women, respectively, and by repeated scans in 27 women. Sensitivity and
specificity were computed at pre-specified thresholds. The smallest real
differences detectable of BWT were estimated using one-way analysis of variance.
The pain and acceptability of both tests were evaluated by a questionnaire.
Patient symptoms were measured before testing and after 6 and 12 months using the
International Consultation on Incontinence modular Questionnaire Overactive
Bladder (short form) (ICIQ-OAB) questionnaire and a global impression of
improvement elicited at 12 months. Interventions and patient outcomes were
analysed according to urodynamic diagnoses and BWT measurements. A
decision-analytic model compared the cost-effectiveness of care strategies using
UDS, ultrasonography or clinical history, estimating the cost per woman
successfully treated and the cost per quality-adjusted life-year (QALY). RESULTS:
BWT showed very low sensitivity and specificity at all pre-specified cut-off
points, and there was no evidence of discrimination at any threshold (p?=?0.25).
Extensive sensitivity and subgroup analyses did not alter the interpretation of
these findings. The smallest detectable difference in BWT was estimated to be
2?mm. Pain levels following both tests appeared relatively low. The proportion of
women who found the test 'totally acceptable' was significantly higher with
ultrasonography than UDS (81% vs. 56%; p?0.001). Overall, subsequent treatment
was highly associated with urodynamic diagnosis (p?0.0001). There was no
evidence that BWT had any relationship with the global impression of improvement
responses at 20 months (p?=?0.4). Bladder ultrasonography was more costly and
less effective than the other strategies. The incremental cost-effectiveness
ratio (ICER) of basing treatment on the primary clinical presentation compared
with UDS was £491,500 per woman successfully treated and £60,200 per QALY.
Performing a UDS in those women with a clinical history of mixed urinary
incontinence had an ICER of £19,500 per woman successfully treated and £12,700
per QALY compared with the provision of urodynamic to all women. For DO cases
detected, UDS was the most cost-effective strategy. CONCLUSION: There was no
evidence that BWT had any relationship with DO, regardless of the cut-off point,
nor any relationship to symptoms as measured by the ICIQ-OAB. Bladder
ultrasonography has no diagnostic or prognostic value as a test in this
condition. Furthermore, despite its greater acceptability, BWT measurement was
not sufficiently reliable or reproducible. TRIAL REGISTRATION: Current Controlled
Trials ISRCTN46820623. FUNDING: This project was funded by the National Institute
for Health Research (NIHR) Health Technology Assessment programme and will be
published in full in Health Technology Assessment; Vol. 20, No. 7. See the NIHR
Journals Library website for further project information.