The Effects of Age, Gender, and Postvoid Residual Volume on Catheterization Rates After Treatment with OnabotulinumtoxinA for Overactive Bladder
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SUBMITTER: Dmochowski R
PROVIDER: S-EPMC10658411 | biostudies-literature | 2023 Oct
REPOSITORIES: biostudies-literature
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Project description:OnabotulinumtoxinA injection is a safe and effective treatment for adults with refractory overactive bladder. There is sufficient level 1 evidence to support offering onabotulinumtoxinA injections as a second-line treatment to patients who have failed behavioral therapy and oral medications such as antimuscarinics and β3 agonists. An intradetrusor injection of 100 U of onabotulinumtoxinA is likely the optimal dose to balance risks and benefits, and this is the dose approved by the US Food and Drug Administration. Improvement in urgency urinary incontinence episodes, as well as symptom scores and quality of life, were seen in around 60%-65% of patients, and were significantly improved compared with those on placebo. Most studies have reported a duration of symptom relief ranging from 6 to 12 months, with repeat injections being safe and efficacious. Overall, the risk of urinary retention was around 6% across the study populations.
| S-EPMC4114914 | biostudies-literature
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.
| S-EPMC10108158 | biostudies-literature
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.
| S-EPMC4769403 | biostudies-other
Project description:A 67-year-old female with refractory OAB was treated with intradetrusor Botox. She subsequently developed multiple papillary bladder lesions with tissue biopsy showing Von Brunn's nests. Von Brunn's nests are benign bladder lesions similar in appearance to a rare urothelial tumor called Nested Variant of Urothelial Carcinoma (NVUC). It is critical that patients with these findings undergo evaluation to rule out the presence of carcinoma. This finding suggests the possibility of a previously unreported adverse reaction in association with intradetrusor Botox.
| S-EPMC5552020 | biostudies-other
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.
| S-EPMC4732812 | biostudies-literature
Project description:The postvoid residual volume (PVR) is a common urodynamic parameter used to quantify the severity of lower urinary tract dysfunction. However, the serial cystometrograms that are typically used to assess bladder function in animal models make measuring PVR very difficult. Current approaches are to either remove PVR after each void to measure it, which is disruptive to the bladder, or to neglect the unknown contribution to PVR from ureter flow, which results in inaccurate estimates. We propose a procedure to estimate PVR during a serial cystometrogram that requires only a single measurement, rather than measuring after each void. Moreover, this measurement can occur at the end of the experiment such that it does not affect the bladder during data collection. We mathematically express PVR for all voids during a serial cystometrogram using a linear recurrence equation and use this equation to build an estimation procedure for PVR. Using in vivo measurements in urethane anesthetized rats and computer simulations we show that the estimation procedure is at least as accurate in determining PVR as the traditional method of measuring PVR after each void. Furthermore, we demonstrate the adverse effects of repeated PVR measurements in a common animal model of cystitis. Using the proposed procedure can increase the efficiency and accuracy of determining PVR for a serial cystometrogram and is less disruptive to the system under study. This, in turn, allows the calculation of other urodynamic parameters that are critical for research studies, including voiding efficiency and bladder capacity.
| S-EPMC5008678 | biostudies-literature
Project description: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.
| S-EPMC8394450 | biostudies-literature
Project description:Introduction and hypothesisIn randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and well-tolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). However, data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Here, we present the results from a large, first-of-its-kind real-world study in patients with OAB.MethodsThis was a prospective, observational, multinational study (GRACE; ClinicalTrials.gov , NCT02161159) performed in four European countries. Patients (N = 504) aged ≥ 18 years with OAB inadequately managed with ≥ 1 anticholinergic received onabotulinumtoxinA per their physician's normal clinical practice.ResultsPhysicians primarily used rigid cystoscopes for onabotulinumtoxinA injection; anesthesia/analgesia was utilized during most treatment procedures. Significant reductions in UI episodes/day from baseline to weeks 1 and 12 were observed as well as in micturition, urgency, and nocturia episodes/day. These improvements in urinary symptoms corresponded to higher scores on the treatment benefit scale at week 12. The use of other OAB medications dropped from baseline to weeks 1 and 12 and was sustained to week 52, which paralleled a reduction in the number of incontinence products used during that time frame. Adverse reactions were reported in 2.6% of patients throughout the study.ConclusionsIn this real-world study, significant improvements in urinary symptoms were seen following onabotulinumtoxinA treatment as early as week 1 and sustained to at least week 12. This was accompanied by a reduced reliance upon incontinence products and reduction in concomitant OAB medication use. OnabotulinumtoxinA was well tolerated with no new safety signals.
| S-EPMC7788019 | biostudies-literature
Project description:IntroductionA prespecified pooled analysis of two placebo-controlled, phase 3 trials evaluated whether the number of prior anticholinergics used or reason for their discontinuation affected the treatment response to onabotulinumtoxinA 100U in overactive bladder (OAB) patients with urinary incontinence (UI).MethodsPatients with symptoms of OAB received intradetrusor injections of onabotulinumtoxinA 100U or placebo, sparing the trigone. Change from baseline at week 12 in UI episodes/day, proportion of patients reporting a positive response ('greatly improved' or 'improved') on the treatment benefit scale (TBS), micturition and urgency were evaluated by number of prior anticholinergics (1, 2 or ≥ 3) and reason for their discontinuation (insufficient efficacy or side effects). Adverse events (AE) were assessed.ResultsPatients had taken an average of 2.4 anticholinergics before study enrolment. OnabotulinumtoxinA reduced UI episodes/day from baseline vs. placebo, regardless of the number of prior anticholinergics (-2.82 vs. -1.52 for one prior anticholinergic; -2.58 vs. -0.58 for two prior anticholinergics; and -2.92 vs. -0.73 for three or more prior anticholinergics; all p < 0.001). The proportion of TBS responders was higher with onabotulinumtoxinA vs. placebo (69.0% vs. 37.2% for one prior anticholinergic; 58.8% vs. 24.8% for two prior anticholinergics and 56.4% vs. 22.5% for three or more prior anticholinergics; all p < 0.001). Similar results were observed regardless of the reason for discontinuation. OnabotulinumtoxinA reduced the episodes of urgency and frequency of micturition vs. placebo in all groups. AEs were well tolerated, with a comparable incidence in all groups.ConclusionIn patients with symptoms of OAB who were inadequately managed by one or more anticholinergics, onabotulinumtoxinA 100U provided significant and similar treatment benefit and safety profile regardless of the number of prior anticholinergics used or reason for inadequate management of OAB. ClinicalTrials.gov: NCT00910845, NCT00910520.
| S-EPMC4282287 | biostudies-literature
Project description:Introduction Intravesical onabotulinumA injection is actively used for the treatment of overactive bladder (OAB). However, it occasionally results in significant post-void residual urine (PVR) volume, which can lead to complications and can further impair the activities of daily living in older people. Therefore, this study aimed to identify the predictors of a high post-onabotulinumA injection PVR volume in older women with severe OAB. Methods An observational study was conducted on older women who had previously received intravesical onabotulinumA injections to treat OAB between 2020 and 2022. Urodynamic studies and symptom assessments were conducted, and machine learning models, including random forest and support vector machine (SVM) models, were developed using the R code generated by Chat Generative Pre-trained Transformer 4 (ChatGPT, OpenAI, San Francisco, USA). Results Among 128 patients with OAB, 23 (18.0%) had a PVR volume of > 200 mL after receiving onabotulinumA injections. The factors associated with a PVR volume of > 200 mL were investigated using univariate and multivariate analyses. Age, frailty, OAB-wet, daytime frequency, and nocturia were significant predictors. Random forest analysis highlighted daytime frequency, frailty, and voiding efficiency as important factors. An SVM model incorporating daytime frequency, frailty, and voiding efficiency improved PVR volume prediction. Logit(p) estimation yielded an area under the receiver operating characteristic curve of 0.926294. Conclusion The study found daytime frequency, frailty, and voiding inefficiency to be significant factors associated with a PVR volume of > 200 mL, in older women with severe OAB. Utilizing advanced machine learning techniques and following the guidance of ChatGPT, this research emphasizes the relevance of considering multiple intersecting factors for predicting PVR volume. The findings contribute to our understanding of onabotulinumA injection treatment for OAB and support evidence-based decision-making using readily available information.
| S-EPMC10387135 | biostudies-literature