Dataset Information

Cost-Utility Analysis of Oxybutynin vs. OnabotulinumtoxinA (Botox) in the Treatment of Overactive Bladder Syndrome.

ABSTRACT: Background: The UK National Health Service (NHS) propose the use of oxybutynin prior to onabotulinumtoxinA (Botox) in the management of overactive bladder syndrome (OAB). Oxybutynin is costly and associated with poor adherence, which may not occur with Botox. We conducted a cost-utility analysis (CUA) to compare the medications. Methods: we compared the two treatments in quality-adjusted life years (QALYS), through the NHS's perspective. Costs were obtained from UK-based sources and were discounted. Total costs were determined by adding the treatment cost and management cost for complications on each branch. A 12-month time frame was used to model the data into a decision tree. Results: Our results found that using Botox first-line had greater cost utility than oxybutynin. The health net benefit calculation showed an increase in 0.22 QALYs when Botox was used first-line. Botox also had greater cost-effectiveness, with the exception of pediatric patients with an ICER of £42,272.14, which is above the NICE threshold of £30,000. Conclusion: Botox was found to be more cost-effective than antimuscarinics in the management of OAB in adults, however less cost-effective in younger patients. This predicates the need for further research to ascertain the age at which Botox becomes cost-effective in the management of OAB.

SUBMITTER: Shabir H

PROVIDER: S-EPMC8394450 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Cost-Utility Analysis of Oxybutynin vs. OnabotulinumtoxinA (Botox) in the Treatment of Overactive Bladder Syndrome.

Shabir Habiba H Hashemi Sana S Al-Rufayie Moussa M Adelowo Tayo T Riaz Umar U Ullah Umayair U Alam Benyamin B Anwar Mehreen M de Preux Laure L

International journal of environmental research and public health 20210819 16

<i>Background:</i> The UK National Health Service (NHS) propose the use of oxybutynin prior to onabotulinumtoxinA (Botox) in the management of overactive bladder syndrome (OAB). Oxybutynin is costly and associated with poor adherence, which may not occur with Botox. We conducted a cost-utility analysis (CUA) to compare the medications. <i>Methods:</i> we compared the two treatments in quality-adjusted life years (QALYS), through the NHS's perspective. Costs were obtained from UK-based sources an ...[more]

PMID: 34444493

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Project description:BackgroundIntradetrusor onabotulinumtoxinA injection is an effective advanced treatment for overactive bladder. While the effective dosages have been well studied, very little data exist on treatment efficacy using differing injection techniques. The objective of this study was to determine whether the efficacy of a reduced injection technique of 5 injection sites was noninferior to the standard technique of 20 injection sites of intradetrusor onabotulinumtoxinA for treatment of overactive bladder.MethodsIn this randomized noninferiority trial, men and women seeking treatment of overactive bladder with intradetrusor onabotulinumtoxinA injections were randomized to receive 100 units administered via either a reduced injection technique of 5 injection sites or a standard injection technique of 20 injection sites. Subjects completed a series of standardized questionnaires at baseline and at 4-12 weeks postprocedure to determine symptom severity and treatment efficacy. The primary outcome was treatment efficacy as determined by Overactive Bladder Questionnaire-Short Form with a noninferiority margin of 15 points. Secondary outcomes were incidence of urinary tract infection and urinary retention requiring catheterization.ResultsData from 77 subjects were available for analysis with 39 in the control arm (20 injections) and 38 in the study arm (5 injections). There was a significant improvement in both arms from baseline to follow-up in Overactive Bladder Questionnaire-Short Form and International Consultation on Incontinence Questionnaire scores (p < 0.001). Overall treatment success was 68% with no statistically significant difference between arms. A significant difference between arms was found on the Overactive Bladder Questionnaire-Short Form quality of life survey favoring the control arm (confidence interval [CI]: 0.36-20.5, p = 0.04). However, there were no significant differences between arms in the remaining validated questionnaires. The study arm did not demonstrate noninferiority to the control arm. Subjects in the study arm were significantly more likely to express a willingness to undergo the procedure again (odds ratio = 3.8, 95% CI: 1.42-10.67, p = 0.004). Adverse events did not differ between arms.ConclusionsA reduced injection technique for administration of intradetrusor onabotulinumtoxinA demonstrates similar efficacy to the standard injection technique but did not demonstrate noninferiority. Subjects preferred the reduced injection technique over the standard technique. A reduced injection technique is a safe and effective alternative to the standard technique.

Project description:OnabotulinumtoxinA and mirabegron have recently gained marketing authorisation to treat symptoms of overactive bladder (OAB).To evaluate the relative efficacy of mirabegron and onabotulinumtoxinA in patients with idiopathic OAB.Network meta-analysis.A search of 9 electronic databases, review documents, guidelines and websites.Randomised trials comparing any licensed dose of onabotulinumtoxinA or mirabegron with each other, anticholinergic drugs or placebo were eligible (19 randomised trials were identified). 1 reviewer extracted data from the studies and a second reviewer checked the data. Candidate trials were assessed for similarity and networks were developed for each outcome. Bayesian network meta-analysis was conducted using both fixed-effects and random-effects models. When there were differences in mean baseline values between mirabegron and onabotulinumtoxinA trials they were adjusted for using network meta-regression (NMR).No studies directly comparing onabotulinumtoxinA to mirabegron were identified. A network was created for each of the 7 outcomes, with 3-9 studies included in each individual network. The trials included in the networks were broadly similar. Patients in the onabotulinumtoxinA trials had more urinary incontinence and urgency episodes at baseline than patients in the mirabegron trials and these differences were adjusted for using NMR. Both onabotulinumtoxinA and mirabegron were more efficacious than placebo at reducing the frequency of urinary incontinence, urgency, urination and nocturia. OnabotulinumtoxinA was more efficacious than mirabegron (50 and 25 mg) in completely resolving daily episodes of urinary incontinence and urgency and in reducing the frequency of urinary incontinence, urgency and urination. NMR supported the results of the network meta-analysis.In the absence of head-to-head trials comparing onabotulinumtoxinA to mirabegron, this indirect comparison indicates that onabotulinumtoxinA may be superior to mirabegron in improving symptoms of urinary incontinence, urgency and urinary frequency in patients with idiopathic OAB.

Project description:ObjectivesTo analyze the predictors of therapeutic efficacy after intravesical botulinum toxin A injection for overactive bladder syndrome (OAB) refractory to antimuscarinic therapy.MethodsAll consecutively OAB patients, who visited the urologic outpatient clinics of a medical center and refractory to antimuscarinic treatment, were prospectively enrolled. All enrolled patients received intravesical injection of 100 U onabotulinumtoxinA (Botox). The Global Response Assessment (GRA) score ≥ 2 at 3 months after Botox injection was defined as a successful treatment, otherwise failed.ResultsOverall, 89 patients received intravesical injection. Eighty patients, including 42 men and 38 women, had received follow-up at 3 months. The overall success rate was 63.8%. The global response assessment, urgency severity score, urgency, urgency urinary incontinence and frequency episodes, and functional bladder capacity improved after treatment. However, post-void residual volume (PVR) increased, and voiding efficiency (VE) decreased after treatment. Female gender (odds ratio = 3.75) was the only independent factor associated with the success. Female gender (coefficient = 0.74), low baseline overactive bladder symptoms score (coefficient = -0.12) and the presence of OAB-wet (coefficient = 0.79) were independent factors associated with therapeutic efficacy (i.e., GRA score). VE (odds ratio = 0.062) was the only predictor for a large PVR at 3 months. The optimum cutoff value of VE was <87% with the area under the ROC curve being 0.64 (sensitivity = 63.8%, specificity = 57.1%).ConclusionsThe therapeutic effects of Botox can persist till 6 months after treatment. Female gender, low overactive bladder symptoms score and OAB-wet are associated better therapeutic efficacy, and low baseline VE is associated with large PVR. These findings can serve as an initial guide or assist in consultation regarding the treatment of OAB patients with Botox injection.Trial registrationClinicalTrials.gov NCT01657409.

Project description:BackgroundTransient increases in postvoid residual urine volume (PVR) requiring clean intermittent catheterization (CIC) have occurred with onabotulinumtoxinA treatment for overactive bladder (OAB).ObjectiveTo evaluate onabotulinumtoxinA safety and the effect of age, gender, and maximum PVR (PVRmax) on CIC initiation in adults with OAB and urinary incontinence (UI).Design setting and participantsThis was a pooled post hoc analysis of four placebo-controlled, multicenter randomized trials that included adults with idiopathic OAB after first onabotulinumtoxinA treatment (NCT00910845, NCT00910520, NCT01767519, NCT01945489). Patients had at least three urgency UI episodes over 3 d and at least eight micturitions per day, had inadequate management with at least one anticholinergic agent, and were willing to use CIC.Outcome measurements and statistical analysisWe measured the following outcomes: PVRmax within 12 wk after first treatment; CIC incidence; estimated functional capacity; PVR ratio (PVR/estimated functional capacity).Results and limitationsOf 1504 patients, 87.7% were women and 88.8% were White. The mean age was 60.5 yr across 10-yr age groups, baseline PVR was 13.8-35.0 ml, and estimated functional capacity was 293.5-475.7 ml. Mean baseline PVR was 21.3 ml overall versus 34.0 ml in the group that started CIC. The CIC incidence was 6.2% for women (range 1.1-8.4%) and 10.5% for men (range 0-14.6%). Higher CIC rates were observed for PVRmax >350 ml (women 91.9%, men 84.6%) in comparison to PVRmax of 201-350 ml (women 32.5%, men 17.4%) and PVRmax <200 ml (women 1.2%, men 1.6%). Overall, 2/1504 patients (both women) were unable to void spontaneously. The mean PVR ratio was highest at week 2. Some subgroups had small sample sizes.ConclusionsCIC incidence was low overall, was less frequent for women, was rare with PVRmax ≤200 ml, and did not appear to correlate with baseline PVR.Patient summaryAfter onabotulinumtoxinA treatment for OAB, patients sometimes insert a catheter to help in emptying their bladder after urinating. In this study, few patients needed a catheter, especially when less urine volume remained after urination.

Dataset Information

Cost-Utility Analysis of Oxybutynin vs. OnabotulinumtoxinA (Botox) in the Treatment of Overactive Bladder Syndrome.

Publications

Cost-Utility Analysis of Oxybutynin vs. OnabotulinumtoxinA (Botox) in the Treatment of Overactive Bladder Syndrome.

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