Intravesical onabotulinumtoxinA Injection Research Articles

The First Injection: Rates of Urinary Retention in Women With Urgency Incontinence Treated With Intravesical OnabotulinumtoxinA Injection.

The aim of the study was to describe the rate of symptomatic and asymptomatic urinary retention and catheterization in women undergoing initial intravesical onabotulinumtoxinA (BnTA) injection for urgency urinary incontinence (UUI). This retrospective chart review included women receiving initial 100 U of BnTA injection for UUI for 5 years. Straight-catheterized postvoid residuals (PVRs) were performed 2 weeks after the injection. Women without the sensation of incomplete bladder emptying, worsened urgency, inability to void, or suprapubic pain but with PVR of greater than 300 mL were characterized as having asymptomatic retention, whereas women with a PVR of greater than 150 and any of these symptoms were diagnosed with symptomatic retention. One hundred eighty-seven 187 patients received initial BnTA injection. The majority were postmenopausal (89%) and white (82%) with a mean age of 65 years and body mass index of 30 kg/m2. One-third of the cohort underwent baseline urodynamic studies. At 2 weeks after injection, 163 patients (87%) followed up, and 17 (10%) had either asymptomatic or symptomatic retention (2% and 8%, respectively). There were no differences in demographic or pretreatment urodynamic parameters in women with and without retention except that women who had previous anti-stress urinary incontinence procedures were more likely to experience retention (53% vs 18%, P = 0.002) despite similar baseline PVRs. We demonstrated that the rate of retention requiring catheterization after 100 U BnTA may be as high as 10% although only 5% develop PVRs for 300 mL and only 2% have asymptomatic retention for 300 mL.

PD24-07 PREDICTIVE FACTORS FOR A SUCCESSFUL TREATMENT OUTCOME OF INTRAVESICAL BOTULINUM TOXIN A INJECTION FOR PATIENTS WITH INTERSTITIAL CYSTITIS/ BLADDER PAIN SYNDROME

INTRODUCTION AND OBJECTIVE:Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). Patients with IC/BPS have different pheno...

45: The first injection: Rates of urinary retention in women with urgency incontinence treated with intravesical onabotulinumtoxinA (Botox) injection

To describe rate and risks for symptomatic and asymptomatic urinary retention requiring catheterization in women undergoing initial intravesical onabotulinumtoxinA (Botox) injection for urgency urinary incontinence (UUI). This was a retrospective chart review of women receiving their first 100 unit Botox injection for idiopathic UUI over 5-years. All patients had straight-catheterized post-void residual (PVR) done 2-weeks after injection. Based on symptoms and PVR patients were divided into “retention” and “non-retention” groups. The “retention” group was further divided into asymptomatic patients with a PVR greater than 300 mL or symptomatic patients with a PVR greater than 150 mL. Symptoms of retention included a sensation of incomplete bladder emptying, worsened urgency or frequency, difficulty/inability to void, or suprapubic pain. Continuous variables were compared using student t tests and categorical variables using χ2 tests. 187 patients with mean age of 65 ± 12 years and BMI of 29.7 ± 7.5kg/m2 were included. Majority was postmenopausal (89%) and white (82%). 69 underwent urodynamic testing (UDS) with 50% demonstrating DO. Mean baseline PVR was 27±30 ml. 163 patients (87%) followed up at 2-weeks. 17 (10%) had retention requiring catheterization: 4 were asymptomatic (PVR >300 mL) and 13 were symptomatic (9 with PVR >150 and <300ml and 4 with PVR >300 ml. Most (13 patients) elected to manage retention with intermittent straight catheterization and 1 with Foley. Three declined to have any catheterization. 20% had a symptomatic, culture-proven UTI in the first month after injection: 35% with and 19% without retention (p=0.09). There were no differences in maximum cystometric capacity (359±150 ml vs 321±105 ml, p= 0.64, baseline PVR (25±27ml vs 46±52 ml, p=0.12) or presence of DO (57% vs 29%, p = 0.16) in women with and without retention. Age (p=0.58), menopausal status (p=1.0), diabetes (p=1.0), and smoking (p=0.16) were not associated with retention. However, women who had previous anti-SUI procedures were more likely to experience retention (53% vs 18%, p = 0.002) even though they did not have higher baseline PVRs (32 vs 26ml, p=0.3). One in 10 women experienced clinically significant urinary retention within 2-weeks of initial Botox for UUI. Nearly all (98%) were symptomatic suggesting that routine PVR follow-up is unnecessary.

Re: What is the True Catheterization Rate after Intravesical OnabotulinumtoxinA Injection?

Re: What is the True Catheterization Rate after Intravesical OnabotulinumtoxinA Injection?

PD06-11 INTRAVESICAL BOTULINUM TOXIN A INJECTIONS IN PATIENTS ON ANTIPLATELET AND ANTICOAGULATION THERAPY

INTRODUCTION AND OBJECTIVES:Intravesical OnabotulinumToxin-A(Botox) injections are an established treatment for idiopathic and neurogenic detrusor overactivity (IDO and NDO). The patient population...

Surgery for urinary incontinence in women: Report from the 6th international consultation on incontinence.

Urinary incontinence is a prevalent condition worldwide and causes a tremendous impact on a woman's quality of life. While conservative and non-surgical therapies are options for treatment, surgery for stress urinary incontinence (SUI) is common. Options include colposuspension, slings (pubovaginal and midurethral), and periurethral bulking. While evidence supports each of these options in the treatment of SUI, each is associated with various rates of success and unique adverse event profiles. Urgency urinary incontinence (UUI) is initially treated with behavioral modification and pharmacologic means, with surgery reserved for those with refractory symptoms or significant complications from medication use. At present, intravesical onabotulinumtoxinA injections, percutaneous tibial nerve stimulation, and sacral neurostimulation are all viable options for refractory UUI/overactive bladder. As with surgical interventions for SUI, each of these is, likewise, associated with unique outcomes and adverse event profiles. Herein, we summarize the findings and conclusions from the 6th International Consultation on Incontinence (ICI) regarding surgical treatment of urinary incontinence in women.

7] Efficacy, complications and tolerability of repeated intravesical onabotulinumtoxinA injections in interstitial cystitis/bladder pain syndrome

ObjectiveTo evaluate the outcome, safety, and patient’s tolerability of repeated intravesical onabotulinumtoxinA (BOTOX) injection for interstitial cystitis (IC)/bladder pain syndrome (PBS).

What Is the True Catheterization Rate After Intravesical OnabotulinumtoxinA Injection?

(Abstracted from Int Urogynecol J 2018;29:1005–1009) Intravesical onabotulinumtoxinA (Botox) is widely used for the treatment of urinary urge incontinence and overactive bladder (OAB). One of the most common complications of intravesical onabotulinumtoxinA injection is incomplete bladder emptying requiring clean intermittent catheterization (CIC).

Can Intradetrusor OnabotulinumtoxinA Injections Alter Heart Function in Patients with Cardiac Arrhythmia?

The prevalence of overactive bladder (OAB) increases with age and can be associated with other co-morbidities, such as cardiac arrhythmia. Unfortunately, commonly used anticholinergic drugs for OAB can affect the cardiovascular system, leading to tachycardia. However, there are no data, which consider the influence of intradetrusor onabotulinumtoxinA injections on heart function in idiopathic OAB patients. The aim of the present study was to evaluate the influence of intradetrusor onabotulinumtoxinA injections on electrocardiogram (ECG) parameters. Additionally, changes in ECG were analyzed in OAB patients without cardiac arrhythmia. Thirty-one patients with cardiac arrhythmia and 31 participants without irregular heart rate (HR) completed the study. ECG measurements were performed in supine positions 2 h before onabotulinumtoxinA injections, 1 h after treatment, and at 2 weeks of follow-up. At week 6, a phone-call survey was conducted to collect data about adverse events. OnabotulinumtoxinA injections were performed with rigid cystoscopy under local anesthesia. We did not observe any clinically significant changes in the analyzed ECG parameters between consecutive measurements. While a slight increase of HR was observed in patients without cardiac arrhythmia, it remained within normal range. Intravesical onabotulinumtoxinA injections are, hence, safe for female patients with cardiac arrhythmia and do not significantly influence changes in ECG.

A hypothesis for the mechanism of urine incontinence in patients after radical prostatectomy due to urinary bladder hypertrophy.

Prostate cancer is one of the most common neoplasms in elderly males in Europe and is rapidly becoming a major health burden throughout the world. Radical prostatectomy is a first-line treatment in the case of organ-confined prostate cancer and in selected cases of locally advanced disease. Recent studies have suggested that the urinary bladder wall thickness (BWT) is an important predictor of an overactive bladder (OAB). This article focuses on a hypothesis for the mechanism of urine incontinence in patients after radical prostatectomy due to urinary bladder hypertrophy. To verify the possible influence of changes in the urinary bladder structure on urine incontinence development, we designed an experiment in which patients with prostate cancer were qualified for radical prostatectomy. Our hypothesis that urinary bladder hypertrophy influences urine incontinence development in patients after radical prostatectomy may provide an insight toward the prevention and control of urine incontinence after surgery by oral pharmacotherapy or intravesical onabotulinumtoxinA injections in pre-radical prostatectomy mode.

Onabotulinumtoxin-A improves health status and urinary symptoms in subjects with refractory overactive bladder: Real-life experience.

Onabotulinumtoxin-A has been approved for wet overactive bladder refractory to anticholinergics in randomised controlled trials; however, data from real-life practice are scarce. This study was designed to assess the efficacy of intravesical onabotulinumtoxin-A injections, focusing on health status, urinary symptoms and subjective satisfaction. Data from consecutive patients with overactive bladder-refractory to anticholinergics treated with onabotulinumtoxin-A were prospectively collected and analysed. Standard doses (100-150 U) were used, followed by repeat sessions when clinical benefits diminished. Efficacy and safety of repeat onabotulinumtoxin-A administrations were assessed at 12-week post-injection. Clinical parameters evaluated were: change in the magnitude and frequency of incontinence, urgency and nocturia episodes, change in the number of pads used and procedural complications. Quality of life was evaluated using the 36-Item Short-Form Health Survey, Overactive Bladder Screener and Treatment Benefit Scale questionnaires. Consecutive overactive bladder-refractory to anticholinergics patients ( n = 22) (median duration of oral therapy: 10 months) were enrolled. No intraoperative complications occurred, but two urinary retention cases were recorded. Forty-five percent of patients (10/22) were re-treated (median duration of perceived benefits: 18 months, range: 8-55 months). The number of urinary incontinence, frequency and nocturia episodes, and pads used went from 3.6, 11.3, 2.7 and 2.4 preoperatively to 1.0, 5.8, 0.7 and 0.7 postoperatively ( p < 0.005). Quality of life (36-Item Short-Form Health Survey) was significantly improved and symptom scores (Overactive Bladder Screener) were reduced, from 34.5 to 17.1 at week 12 ( p < 0.05). Eighty-seven percent of patients indicated improvement/great improvement in their condition (Treatment Benefit Scale). Intradetrusor injections of onabotulinumtoxin-A in patients with overactive bladder-refractory to anticholinergics significantly improved health status and urinary symptoms, with high subjective satisfaction.

What is the Best Treatment Option for Coexisting Pelvic Floor Dysfunctions?

Although both intravesical onabotulinumtoxinA injections and sacral neuromodulation could be offered in cases of bladder pain syndrome and overactive bladder syndrome, there is still no scientific agreement on the best option after failure of standard therapies.

Strategy of clinical diagnosis and treatment in women with lower urinary tract symptoms

Lower urinary tract symptoms (LUTS) are common in women. The etiology , clinical manifestation, diagnosis and management of LUTS in women are different from those in men. A detailed history, a physical examination and a urine analysis are essential components of the initial evaluation of lower urinary tract symptoms in the female. Thoroughly treating urinary tract infection is very important in management of frequency . In addition, management of fluid intake, behavioral and drug therapies are often used in combination to optimize patient symptom and the quality of life. Intravesical injection of onabotulinumtoxinA is highly effective, but often requires repeated treatments. Sacral neuromodulation is an effective, minimally invasive surgical treatment for refractory overactive bladder in carefully selected, cognitively capable patients. Detrusor underactivity is a common cause of LUTS in women. Female bladder outlet obstruction was divided into two categories, anatomical and functional obstruction. So far, there is no uniform urodynamic standard for diagnosing bladder outlet obstruction in women . The clinical manifestations are various in different types of obstruction , so is the management. It is important to find out the causes of obstruction, and only in this way can we get correct diagnosis, thus treating patients successfully. Key words: Lower urinary tract symptoms; Female; Diagnosis; Treatment

What is the true catheterization rate after intravesical onabotulinumtoxinA injection?

A known side effect of intravesical onabotulinumtoxinA (Botox®) injection for overactive bladder (OAB) is urinary retention requiring clean intermittent catheterization (CIC), the fear of which deters patients from choosing this therapy. In clinical practice, patients with an elevated postvoid residual (PVR) are often managed by observation only, providing they do not have subjective complaints or contraindications. We sought to determine the true rate of urinary retention requiring CIC in clinical practice. A retrospective review was performed over a 3-year period of patients who received 100units of intravesical onabotulinumtoxinA for the treatment of OAB. Patients were seen 2weeks after the procedure to measure PVR. CIC was initiated in patients with a PVR ≥350ml and in those with subjective voiding difficulty or acute retention. A total of 187 injections were performed on 99 female patients. CIC was required following three injections (1.6%): for acute retention in two patients and subjective voiding difficulty in one patient with a PVR of 353ml. Following 12 injections, the patient had a PVR of ≥350ml, and following 29 injections, the patient had a PVR of >200 but <350ml without symptoms. CIC was not initiated in these 41 patients. None of these patients experienced subsequent retention, and all showed resolution of their elevated PVR within 8weeks. In our series of 187 intravesical injections for OAB, the rate of postprocedure urinary retention requiring catheterization was only 1.6%. This low rate can be attributed to less rigorous criteria for CIC initiation than those applied in previous studies. While important to counsel patients on the risk of retention, patients can be reassured that the actual rate of CIC is low.

Re: Reduction of Urgency Severity is the Most Important Factor in the Subjective Therapeutic Outcome of Intravesical OnabotulinumtoxinA Injection for Overactive Bladder.

Re: Reduction of Urgency Severity is the Most Important Factor in the Subjective Therapeutic Outcome of Intravesical OnabotulinumtoxinA Injection for Overactive Bladder.

OnabotulinumtoxinA in urinary incontinence: Prospective study of a case series

ObjectiveTo assess the safety and efficacy of a single intravesical injection of onabotulinumtoxinA (OnaBTA) for treating urge urinary incontinence (UUI) in women. MethodWe performed a prospective case-series study of consecutive patients with refractory UUI treated with an intravesical injection of OnaBTA. The patients were administered 100 units of OnaBTA injected into the bladder wall following 4 weeks of flushing with anticholinergic agents or beta-3 agonists. The urodynamic and clinical endpoints were evaluated before and 6 months after the injection of OnaBTA. The primary study endpoint was the number of episodes of urinary leakage. ResultsA total of 204 of the 210 selected patients conducted a valid visit 6 months after the therapeutic application. At 6 months of treatment with OnaBTA, 110 (53.9%) patients remained continent and were considered a success. However, 57 (27.9%) patients experienced one episode of urinary leakage per day, and 37 (18.2%) had 2 or more. In terms of the urodynamic parameters, we observed the following changes: increase in maximum bladder capacity (p<0.0001) and reduced maximum pressure of the detrusor (p<0.0001). In terms of the safety profile, 8 (3.9%) patients had self-limiting haematuria during the procedure, which resolved spontaneously, and 9 (4.4%) patients had acute urinary retention that required intermittent catheterisation. ConclusionsThis study supports the use of OnabotulinumtoxinA in patients with urge urinary incontinence that does not respond to medical treatment.

Third-line treatment options for refractory urgency urinary incontinence in women—a commentary to ROSETTA trial

According to the American Urological Association (AUA) and Society of Urodynamics and Female Urology (SUFU) guidelines third-line treatment options for refractory overactive bladder (OAB) include: intradetrusor onabotulinumtoxinA injections (100 units, Botox, Allergan) or sacral neuromodulation (SNS), or peripheral tibial nerve stimulation (PTNS). Intravesical onabotulinumtoxinA injections are ranked as standard treatment (evidence strength: grade B), which is equally to the strongest statement. AUA/SUFU guidelines rank SNS and PTNS as recommended option (evidence strength: grade C). Patients qualified for intravesical onabotulinumtoxinA injections should be warned about the potential risk of urine retention and must be willing to perform clean intermittent self-catheterization (CISC). Sacral neuromodulation may be offered to selected patients, who are willing to undergo two-step surgical procedure (1). SNS is also benefit for patients with idiopathic urinary retention and with urgency symptoms. However, there is still a lack of evidence, which third-line treatment option is superior in patients with refractory overactive bladder (OAB). Interestingly, in the recent study published by Hashim et al . (2) 34% patients with refractory OAB were willing to try sacral neuromodulation and only 9% of patients preferred intravesical Botox injections as a third-line treatment option. On the other hand it is much easier for physicians to inject the detrusor with onabotulinumtoxinA than implant the neurostimulator (the learning curve for Botox is very short and interestingly enough treatment effectiveness does not depend on the experience of performing physician). We should also remember about the cost of procedures. In many countries there is still no health reimbursement either for onabotulinumtoxinA nor SNS.

Urodynamic prognostic factors for large post-void residual urine volume after intravesical injection of onabotulinumtoxinA for overactive bladder

The aim of this study was to identify factors predicting large post-void residual (PVR) (defined as ≥200 mL), an important unsolved problem, after an intravesical injection of onabotulinumtoxinA in patients with overactive bladder syndrome. The data showed that 133 of 290 patients had a large PVR after treatment. Multivariate analysis found that the baseline 3-day daytime frequency episodes and voiding efficiency were independent predictors for postoperative large PVR. A receiver operating characteristic (ROC) curve analysis showed the following optimum cut-off values: (1) 3-day daytime frequency episodes = 25, which has a ROC area of 0.72; and (2) voiding efficiency = 89%, which has a ROC area being 0.66. The predicted logit transformation of probability of large PVR, logit(p), for a given 3-day daytime frequency episodes (a) and voiding efficiency (b%) can be denoted by logit(p) = −5.18 + 0.07 × a + 0.04 × b, with a cutoff value of logit(p) = 0.34 and a ROC area of 0.79. The median value of the persistent large PVR interval was 5 months. In conclusion, low 3-day daytime frequency episodes (<25) and low voiding efficiency (<89%) are associated with large PVR. Besides, logit(p) <0.34 can be used to predict large PVR for its higher ROC area.

Onabotulinumtoxin A en la incontinencia urinaria: estudio prospectivo de serie de casos

ObjectiveTo assess the safety and efficacy of a single intravesical injection of onabotulinumtoxinA (OnaBTA) for treating urge urinary incontinence (UUI) in women. MethodWe performed a prospective case-series study of consecutive patients with refractory UUI treated with an intravesical injection of OnaBTA. The patients were administered 100 units of OnaBTA injected into the bladder wall following 4 weeks of flushing with anticholinergic agents or beta 3 agonists. The urodynamic and clinical endpoints were evaluated before and 6 months after the injection of OnaBTA. The primary study endpoint was the number of episodes of urinary leakage. ResultsA total of 204 of the 210 selected patients conducted a valid visit 6 months after the therapeutic application. At 6 months of treatment with OnaBTA, 110 (53.9%) patients remained continent and were considered a success. However, 57 (27.9%) patients experienced one episode of urinary leakage per day, and 37 (18.2%) had 2 or more. In terms of the urodynamic parameters, we observed the following changes: increase in maximum bladder capacity (P<.0001) and reduced maximum pressure of the detrusor (P<.0001). In terms of the safety profile, 8 (3.9%) patients had self-limiting haematuria during the procedure, which resolved spontaneously, and 9 (4.4%) patients had acute urinary retention that required intermittent catheterisation. ConclusionsThis study supports the use of OnabotulinumtoxinA in patients with urge urinary incontinence that does not respond to medical treatment.

Impact of intravesical onabotulinumtoxinA on sexual function in women with OAB.

Urgency urinary incontinence (UUI), and the symptoms of overactive bladder (OAB) have a negative impact on female sexual function. The aim of this study was to investigate the effect of intravesical onabotulinumtoxinA (Botox) injection on sexual function in women with OAB, using the multi domain Female Sexual Function Index (FSFI) questionnaire. Sixty-eight sexually active women with idiopathic OAB with at least one episode of UUI and ≥8 micturitions per 24 h were recruited. Patients completed the FSFI questionnaire before and 12 weeks after treatment with intravesical onabotulinumtoxinA injections. Baseline scores were compared with a control group of age-matched healthy women. Fifty-six women completed the study. At baseline OAB patients reported decreased quality of sexual function in all domains measured with FSFI, in comparison to healthy women (median 21.8 vs. 26.3, P < 0.001). Over 90% of participants reported clinically relevant improvements in sexual function, with statistically significant changes in mean scores in all six domains. Intravesical Botox injections provide improvement in sexual function in women with OAB. Neurourol. Urodynam. 9999:XX-XX, 2016. © 2016 Wiley Periodicals, Inc.