OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Νitti, Victor W.; Dmochowski, Roger R.; Herschorn, Sender; Sand, Peter K.; Thompson, Catherine; Nardo, Christopher; Yan, Xiaohong; Haag‐Molkenteller, Cornelia

doi:10.1016/j.juro.2016.10.109

Cited by 184 publications

(188 citation statements)

References 18 publications

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“…We demonstrate that the real-time rate of urinary retention in clinical practice is far less than previously reported. Another unique aspect of our study is that 30% of the study population was male, which is significantly higher than the 8% -10% previously reported [2] [6].…”

Section: Discussionmentioning

confidence: 63%

“…However, one of the most common side effects of therapy is urinary retention. In previously published literature, urinary retention was reported to occur in 5% -43% of patients and was shown to be dose-dependent [2]- [7]. The purpose of this study was to assess the real-time rate of urinary retention in clinical practice after administration of BTN/ A for refractory non-neurogenic OAB in a multi-institutional clinical setting.…”

Section: Introductionmentioning

confidence: 99%

“…While no standard definition exists for "refractory OAB", it is a term often used to describe patients who have either failed or were unable to tolerate con- Safety, efficacy and durability of BTN/A have been demonstrated in previously published randomized controlled trials [2] [3] [4]. However, one of the most common side effects of therapy is urinary retention.…”

Section: Introductionmentioning

confidence: 99%

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Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder

Syed¹,

Gomez²,

Gousse³

2017

OJOG

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Introduction: According to the most recent AUA/SUFU guidelines, intradetrusor onabotulinumtoxinA (BTN/A) is a standard, evidence strength grade B, third line treatment option for refractory non-neurogenic overactive bladder (OAB). Urinary retention is the most common clinically significant reported side effect ranging from 5.4% to 43% in previous studies. The aim of this study was to investigate the real-time rate of urinary retention in patients treated with BTN/A for refractory non-neurogenic OAB in a multi-institutional study. Methods: Retrospective chart review identified 71 patients who were treated with 100U BTN/A for refractory non-neurogenic OAB from August 2011 to July 2015 at two institutions. Using a flexible cystoscope, 100U Botox ® reconstituted with 10 ml normal saline was administered. Injections of 1 ml (10 units/ mL) were administered in 10 evenly distributed sites sparing the trigone. Pre and post BTN/A post-void residuals (PVR) were reviewed. Urinary retention was defined as PVR > 200 mL requiring clean intermittent catheterization (CIC). Results: After exclusion, the study group consisted of 66 patients with a mean age of 67 years and 30% were men. Mean pre and post-procedural PVR were 14.06 mL and 69.21 mL. Eight patients (12.12%) were noted to have elevated PVR > 200 mL post injection however only one patient (female) required initiation of CIC. The rate of urinary retention was 1.5% (N = 1). There was no correlation with age, history of previous radiation, diabetes or prior use of a neuromodulator device. Conclusions: To the best of our knowledge, this is the first study to demonstrate a very low risk of real-time urinary retention rates in appropriately selected patients treated with BTN/A for refractory non-neurogenic OAB outside of a clinical trial setting.

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Section: Discussionmentioning

confidence: 63%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder

Syed¹,

Gomez²,

Gousse³

2017

OJOG

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“…4 The efficacy and safety of BTX 100u has been reported in a large, multicentre, phase 3 study of 557 OAB patients. 16 Overall, there was a significantly greater reduction in daily incontinence episodes with BTX compared to placebo, 22.9% of patients achieved complete continence, and there was a corresponding significant improvement in health-related quality of life. The most commonly reported adverse effect was UTI; self-catheterisation rates were 5.4%.…”

Section: Botulinum Toxinmentioning

confidence: 83%

Managing overactive bladder in primary care

Robinson¹,

Belal²,

Granitsiotis³

et al. 2017

Trends Urol & Men's Health

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O veractive bladder (OAB) is the term used to describe the symptom complex of urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology. 1 HOW COMMON IS OAB?Epidemiological studies from North America have reported a prevalence of OAB in women of 16.9%, increasing with age to 30.9% in those over the age of 65 years. 2 Further data from Europe have shown the overall prevalence in men and women over the age of 40 years to be 16.6%. 3 Frequency was the most commonly reported symptom (85%), while 54% complained of urgency and 36% of urgency incontinence. The European Prospective Investigation into Cancer and Nutrition (EPIC) study, a cross-sectional telephone survey conducted in Canada and four European countries including the UK, utilised the International Continence Society terminology (more specific for the current OAB definition) and found the prevalence of OAB to be 12.8% in women and 10.8% in men.

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“…This alternative dose of 200 U was used off label before the compound was registered for idiopathic OAB, but this is not clinical practice at present due to higher chance of adverse events like urinary retention and urinary tract infection [34]. The registered dose of onabotulinumtoxinA for idiopathic OAB is 100 U, which was significantly more effective than placebo at 4 months [35].…”

Section: Oab With or Without Urinary Incontinencementioning

confidence: 99%

Sacral neuromodulation for the treatment of urinary bladder dysfunction: mechanism of action and future directions

Blok

2018

Bioelectronics in Medicine

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Symptoms of overactive bladder affect a large portion of the world population, especially the elderly. Sacral neuromodulation (SNM) is an effective third-line therapy in patients with overactive bladder. The working mechanism of SNM can be explained by the neural connections of the lower urinary tract. It is proposed that SNM does not work directly on the central components of the micturition reflex, but on cortical and subcortical areas, which in turn inhibits the micturition reflex components in the caudal brainstem. The clinical use and outcomes of SNM are described for several forms of bladder dysfunction. Furthermore, some recent new developments in SNM are discussed, such as expanded indications, more effective use of existing nonrechargeable neuromodulators and the introduction of a rechargeable device. Conservative treatment of overactive bladder (OAB) with or without urinary incontinence consists of pelvic floor exercises, medication and lifestyle intervention, including fluid restriction and timely voiding. If these conservative interventions fail, it is possible to offer electrical stimulation therapies, such as sacral neuromodulation (SNM). In patients suffering from urinary urgency, frequency and urgency incontinence, electrical stimulation of the sacral nerve significantly reduces urinary symptoms and improves patient quality of life. SNM is also used effectively for other forms of bladder dysfunction, such as underactive bladder and bladder pain syndrome (BPS). The increased use of minimally invasive SNM has decreased the need for more open surgical procedures such as ileocystoplasty and urinary diversion. SNM uses an implanted electrode to the third or fourth sacral spinal nerve to deliver a nonpainful electrical stimulus. The brain of the patient perceives this stimulus and, in turn, effectively restores bladder function and alleviates the patients' symptoms. Due to the system-oriented, and not organ-oriented, approach, SNM not only treats urinary disorders, but may also have a beneficial effect on bowel and sexual dysfunction as well as on pelvic pain. Normal control of the lower urinary tractIn order to understand the role of the brain in the control of the urinary bladder and its sphincter, one can make a distinction between structures and axonal tracts in the caudal brainstem and spinal cord, which are intrinsic part of the micturition and continence reflex, and structures and pathways, located in the forebrain and mesencephalon, which modulate these micturition and continence areas. Most of the clinical therapies aimed at functional bladder disorders are not specifically targeted to the micturition reflex areas, but influence cortical and subcortical brain areas, which, in turn, modulate the micturition reflex components. Examples of such therapies are pelvic floor physiotherapy, biofeedback, transcutaneous electrical nerve stimulation, posterior tibial nerve stimulation and SNM. Currently, there is no effective behavioral, chemical or electrical treatment which works directly and specifica...

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OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Abstract: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Cited by 184 publications

References 18 publications

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder

Managing overactive bladder in primary care

Sacral neuromodulation for the treatment of urinary bladder dysfunction: mechanism of action and future directions

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OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Abstract: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Cited by 184 publications

References 18 publications

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox&lt;sup&gt;&amp;reg&lt;/sup&gt; for Non-Neurogenic Overactive Bladder

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox&lt;sup&gt;&amp;reg&lt;/sup&gt; for Non-Neurogenic Overactive Bladder

Managing overactive bladder in primary care

Sacral neuromodulation for the treatment of urinary bladder dysfunction: mechanism of action and future directions

Contact Info

Product

Resources

About

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder

Very Low, Real-Time Rate of Urinary Retention after Intradetrusor Botox<sup>&reg</sup> for Non-Neurogenic Overactive Bladder