Repeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

Dowson, Christopher G.; Watkins, Jane; Khan, Mohammad Shamim; Dasgupta, Prokar; Sahai, Amit

doi:10.1016/j.eururo.2011.12.011

Cited by 122 publications

(104 citation statements)

References 20 publications

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“…The probability of SNS being effective in women with DO was taken from a systematic review. 89 Observational studies were used to inform the probability of three repetitive BTX-A injections being effective in women with DO 158 and the cure rate of colposuspension in women with MUI. 163 From the former observational study, the proportion of women that become subjectively cured after three BTX-A injections (56.8%), the disaggregation of the overall effectiveness across the three injections and the drop-out rate after each injection were used in the model (Table 32).…”

Section: Clinical Datamentioning

confidence: 99%

Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation

Rachaneni

McCooty

Middleton

et al. 2016

Health Technol Assess

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BackgroundUrodynamics (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.ObjectivesTo 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.DesignA cross-sectional test accuracy study.Setting22 UK hospitals.Participants687 women with OAB.MethodsBWT 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).ResultsBWT 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.ConclusionThere 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 registrationCurrent Controlled Trials ISRCTN46820623.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 7. See the NIHR Journals Library website for further project information.

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Section: Clinical Datamentioning

confidence: 99%

Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation

Rachaneni

McCooty

Middleton

et al. 2016

Health Technol Assess

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“…Thereafter, a discontinuation rate of 1.4 % per MC was used based on a retrospective study that followed 125 patients with OAB who received onabotulinumtoxinA over a 5-year period [10]. These assumptions broadly agree with the results from a small UK study, in which most discontinuations occurred after the second administration of onabotulinumtoxinA, with few discontinuations thereafter [11].…”

Section: Model Structurementioning

confidence: 94%

OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales

Freemantle¹,

Khalaf

Loveman

et al. 2015

Eur J Health Econ

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The cost-effectiveness of onabotulinumtoxinA (BOTOX Ò ) 100 U ? best supportive care (BSC) was compared with BSC alone in the management of idiopathic overactive bladder in adult patients who are not adequately managed with anticholinergics. BSC included incontinence pads and, for a proportion of patients, anticholinergics and/or occasional clean intermittent catheterisation. A five-state Markov model was used to estimate total costs and outcomes over a 10-year period. The cohort was based on data from two placebo-controlled trials and a long-term extension study of onabotulinumtoxinA. After discontinuation of initial treatment, a proportion of patients progressed to downstream sacral nerve stimulation (SNS). Cost and resource use was estimated from a National Health Service perspective in England and Wales using relevant reference sources for 2012 or 2013. Results showed that onabotulinumtoxinA was associated with lower costs and greater health benefits than BSC in the base case, with probabilistic sensitivity analysis indicating an 89 % probability that the incremental cost-effectiveness ratio would fall below £20,000. OnabotulinumtoxinA remained dominant over BSC in all but two scenarios tested; it was also economically dominant when compared directly with SNS therapy. In conclusion, onabotulinumtoxinA appears to be a cost-effective treatment for overactive bladder compared with BSC alone.

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“…Given the lack of mid-and long-term BoNT/A efficacy data in the published literature, treatment outcomes up to 10 years were estimated from two recent single-centre real-world clinical practice data reports showing the long-term compliance with repeated BoNT/A injections of a total of 204 idiopathic OAB patients treated with various dosages (100-200U) and followed up to 7 years [16,17]. In particular, an annual dropout rate of 11.5 % [13] was considered for the first 3 years, after which a plateauing effect was assumed [16,17].…”

Section: Therapeutic Strategies: Outcomes and Parametersmentioning

confidence: 99%

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System

et al. 2014

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Repeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

Cited by 122 publications

References 20 publications

Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation

Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation

OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System

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