Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study

Νitti, Victor W.; Ginsberg, David A.; Sievert, Karl‐Dietrich; Sussman, David; Radomski, Sidney B.; Sand, Peter K.; Ridder, Dirk De; Jenkins, Brenda; Magyar, Andrew P.; Chapple, Christopher R.; Wurzel, Rafael

doi:10.1016/j.juro.2016.03.146

Cited by 93 publications

(111 citation statements)

References 16 publications

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“…Nitti et al reported on the long-term efficacy of intradetrusor onaBoNT-A in idiopathic OAB patients over 3.5 years 19 . Patients treated with onaBoNT-A saw reductions from baseline in urgency urinary incontince (UUI) by 3.1 to 3.8 episodes per day across 6 treatments 20 .…”

Section: Clinical Efficacy Of Intradetrusor Injectionmentioning

confidence: 99%

Past, Present and Future of Chemodenervation with Botulinum Toxin in the Treatment of Overactive Bladder

et al. 2017

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Purpose We systematically reviewed both pre-clinical and clinical studies on bladder chemodenervation with onabotulinumtoxin A to highlight current limitations and future drug delivery approaches. Materials and Methods We identified peer-reviewed basic and clinical research studies of onabotulinumtoxin A (onaBoNT-A) in the treatment of neurogenic bladder and refractory idiopathic overactive bladder (OAB) published between March 2000 and March 2016. Paired investigators independently screened 125 English language articles to identify controlled studies on onaBoNT-A administration in MEDLINE® database and abstracts presented at annual American Urological Association meetings. The review yielded an evidence base of over 50 articles relevant to the approach of injection free onaBoNT-A chemodenervation. Results The efficacy and safety of intradetrusor injection of onaBoNT-A for the treatment of OAB is sensitive to both injection volume and depth, and this issue has motivated researchers to study injection-free modes of drug delivery into the bladder. Urothelial denudation with protamine sulfate or dimethyl sulfoxide (DMSO), liposome encapsulated onaBoNT-A, and other physical approaches are all being studied to increase toxin permeability and avoid intradetrusor injections. Liposome encapsulated onaBoNT-A enhances toxin activity while reducing its toxin degradation. The safety and efficacy of liposome encapsulated onaBoNT-A was tested in a multi-center, placebo controlled study. Although this treatment successfully reduced urinary frequency and urgency, it did not significantly reduce urgency urinary incontinence episodes. Conclusions Intradetrusor injection of onaBoNT-A is safe and effective as reported in several large multicenter randomized controlled trials. Injection of the toxin into the bladder wall impairs both afferent and efferent nerves, but drug delivery approaches that avoid injections impair only bladder afferent nerves. Further studies are needed to develop better drug delivery platforms that overcome the drawbacks of intradetrusor injection, increase patient acceptance, and reduce the treatment costs.

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Section: Clinical Efficacy Of Intradetrusor Injectionmentioning

confidence: 99%

Past, Present and Future of Chemodenervation with Botulinum Toxin in the Treatment of Overactive Bladder

et al. 2017

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“…This included 839 patients who had been enrolled in the original phase III studies and were invited to continue long-term follow-up (50). The cohort received up to six repeat injections and there was a consistent absolute reduction of UI episodes, ranging from −3.1 to −3.8, across each treatment cycle.…”

Section: Detrusor Overactivity (Do)mentioning

confidence: 99%

Use of botulinum toxin for voiding dysfunction

Eldred‐Evans¹

2017

Transl. Androl. Urol.

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The use of botulinum toxin A (BoNT-A) has expanded across a range of lower urinary tract conditions. This review provides an overview of the current indications for BoNT-A in the lower urinary tract and critically evaluates the published evidence within each area. The classic application of BoNT-A has been in the management of refractory neurogenic detrusor overactivity (NDO) and overactive bladder (OAB). There is a large volume of high-quality evidence, including numerous randomized placebo-controlled trials, which demonstrate the efficacy of BoNT-A over a long follow-up period. The culmination of this robust evidence-base has led to onabotulinumtoxin A (onaBoNT-A) receiving regulatory approval as a second-line treatment for NDO at a dose of 200 U and OAB at dose of 100 U. Other applications for BoNT-A are used on an off-license basis and include interstitial cystitis/bladder pain syndrome (IC/BPS), benign prostatic hyperplasia (BPH), and detrusor sphincter dyssynergia (DSD). These applications are associated with a less mature evidence-base although the literature is rapidly evolving. At present, the results for painful bladder syndrome (PBS) are promising and BoNT-A injections are recommended as a fourth line option in recent international guidelines, although larger randomized study with longer follow-up are required to confirm the initial findings. As a treatment for DSD, BoNT-A injections have shown potential but only in a small number of trials of limited quality. No definite recommendation can be made based on the current evidence. Finally, the results for the treatment of BPH have been variable and recent high quality randomized controlled trials (RCTs) have suggested no benefit over placebo so at present it cannot be recommended for routine clinical practice. Future advances of BoNT-A include liposome encapsulated formulations which are being developed as an alternative to intravesical injections.

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“…With cystoscopic injection of botulinum toxin the duration of benefit is usually about six months [5,9,10] . While the initial response rate was lower in our study, 21% of the patients were still classified as responders at six months, showing that the benefit is long lasting in some of the patients.…”

Section: Duration Of Effectmentioning

confidence: 99%

“…2-3 fewer leaks per 24 hours), 23-55% of patients achieving continence, and a statistically significant improvement in quality of life measures [2][3][4][6][7][8] . The main complications are a 5-36% risk of UTI [2][3][4][5][6]9] and a 4-11% risk of impaired bladder emptying requiring catheterization [1,3,4,6,9] . Some patients also experience postoperative pain and dysuria.…”

Section: Introductionmentioning

confidence: 99%

“…The effect of cystoscopic injection of botulinum toxin is temporary, with median duration of Abstract: effect around six months. However, the treatment may be repeated, and responders typically receive a new injection after 6-8 months [5,9,10] . EMDA (Electromotive Drug Application) is a method for enhancing absorption of drugs into tissues [11] .…”

Section: Introductionmentioning

confidence: 99%

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Intravesical Electromotive Botulinum Toxin in Women with Overactive Bladder – A Pilot Study

2017

ARC Journal of Gynecology and Obstetrics

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Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study

Abstract: Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals.

Cited by 93 publications

References 16 publications

Past, Present and Future of Chemodenervation with Botulinum Toxin in the Treatment of Overactive Bladder

Past, Present and Future of Chemodenervation with Botulinum Toxin in the Treatment of Overactive Bladder

Use of botulinum toxin for voiding dysfunction

Intravesical Electromotive Botulinum Toxin in Women with Overactive Bladder – A Pilot Study

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