Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxina in a randomized, placebo‐controlled dose‐finding study in idiopathic overactive bladder

Rovner, E.S.; Kennelly, Michael; Schulte-Baukloh, Heinrich; Zhou, Jihao; Haag‐Molkenteller, Cornelia; Dasgupta, Prokar

doi:10.1002/nau.21021

Cited by 144 publications

(125 citation statements)

References 24 publications

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“…An investigation into whether or not a diagnostic test is more cost-effective when performed in only specific subgroups of women concluded that the most cost-effective diagnostic strategy is to perform UDS in women with a clinical history of mixed incontinence. This finding seems to be further supported by evidence from clinical studies indicating that in women with OAB only an urodynamic observation of DO does not have an impact on the outcome of more invasive interventions, 84,86,197 but also from evidence indicating that mixed urinary symptoms tend to be more common than mixed UI on UDS. 13,198 The magnitude of DO appears to be close to 50%, 198 as it was also found in the primary study (55%).…”

Section: Strengths and Limitations In Relation To Other Studiesmentioning

confidence: 62%

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: Strengths and Limitations In Relation To Other Studiesmentioning

confidence: 62%

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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“…We excluded 560 articles, resulting in 12 RCTs for analysis. 1 of the 12 trials was only available in abstract form [14] and 3 of the 12 trials reported different outcomes in more than one article but derived from the same trial [8,9,10,15,16]. 1,020 participants were included.…”

Section: Resultsmentioning

confidence: 99%

“…Seven trials compared botulinum toxin-A with placebo [6,7,8,9,10,11,14,16,18,19,20]. They included 782 patients; 23 patients were lost to follow-up.…”

Section: Resultsmentioning

confidence: 99%

“…Different doses of botulinum toxin-A were compared in four trials [7,8,10,11,18,21,22]. A total of 478 patients were included; 18 patients were lost to follow-up.…”

Section: Resultsmentioning

confidence: 99%

“…Only 3 RCTs were included in their review. Since the publication of their review, various new RCTs have been published which included many large sample size studies about botulinum toxin used for idiopathic OAB [6,7,8,9,10,11]. In this paper, we attempt to summarize the data from all RCTs to assess the efficacy and safety of botulinum toxin-A in the management of idiopathic OAB.…”

Section: Introductionmentioning

confidence: 99%

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Botulinum Toxin-A Injections for Idiopathic Overactive Bladder: A Systematic Review and Meta-Analysis

Yu¹,

Wang²,

Liu³

et al. 2013

Urol Int

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Objective: To review the current evidence on the efficacy and safety of botulinum toxin-A in the management of idiopathic overactive bladder (OAB). Methods: A systematic search of PubMed, Embase and the Cochrane Central Search Library was performed. All randomized controlled trials comparing botulinum toxin-A with placebo, different doses and injection techniques, in patients with idiopathic OAB was included. The analyzed outcomes were quantification of symptoms, urodynamic outcomes, quality of life and adverse events. Result: A total of 1,020 participants from 12 randomized controlled trials were included. Botulinum toxin-A was associated with less urinary frequency, less incontinence episodes, improvement in quality of life, higher post-void residual-related catheterization and higher urinary tract infection. Doses of 100-300 U were not consistently differentiated from each other in voiding diary, quality of life and urge urinary incontinence. No statistically significant difference was seen between bladder body and bladder base, bladder body and bladder body plus trigone in urinary retention and urinary tract infection. Conclusion: Botulinum toxin-A is associated with significant improvement in OAB symptoms in patients with idiopathic OAB. However, there is a higher incidence of postoperative urinary retention and urinary infection compared to placebo. Low-dose botulinum toxin-A seems to be the optimum dose that appropriately balances the benefits with adverse events. Trigone inclusion seems as safe and effective as trigone-sparing injection.

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Botulinum toxin for the overactive bladder

Apostolidis

2015

Overactive Bladder

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Urodynamic results and clinical outcomes with intradetrusor injections of onabotulinumtoxina in a randomized, placebo‐controlled dose‐finding study in idiopathic overactive bladder

Cited by 144 publications

References 24 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

Botulinum Toxin-A Injections for Idiopathic Overactive Bladder: A Systematic Review and Meta-Analysis

Botulinum toxin for the overactive bladder

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