A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of OnabotulinumtoxinA 200 U to Treat Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia

McVary, Kevin T.; Roehrborn, Claus G.; Chartier‐Kastler, Emmanuel; Efros, Mitchell; Bugarin, Denise; Chen, Ru; Patel, Anand; Haag‐Molkenteller, Cornelia

doi:10.1016/j.juro.2014.02.004

Cited by 39 publications

(30 citation statements)

References 14 publications

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“…In an analysis of a different prostate injectable, Elhilali et al [60] found a significant placebo response that made it difficult for their injectable protein to demonstrate a statistically significant improvement over placebo. Similar to the endoscopic procedures, increases in Qmax were often pronounced with improvement over 1.5 mL/s commonly seen [57,58].…”

Section: Surgical Treatmentsmentioning

confidence: 75%

“…In the first study looking at injection of botox, no significant response was noted to injection of normal saline [59] with each study afterwards showing a pronounced response. Work by Marberger et al [57] and McVary et al [58] found decreases in AUASS of 27 and 26 %, respectively, in the groups injected with saline. In an analysis of a different prostate injectable, Elhilali et al [60] found a significant placebo response that made it difficult for their injectable protein to demonstrate a statistically significant improvement over placebo.…”

Section: Surgical Treatmentsmentioning

confidence: 89%

“…Studies utilizing prostatic injection have an equally pronounced sham surgical response and this surprising decreases in symptom scores has likely led to the failure of at least botulinum toxin (botox) for prostate injections [57,58]. In the first study looking at injection of botox, no significant response was noted to injection of normal saline [59] with each study afterwards showing a pronounced response.…”

Section: Surgical Treatmentsmentioning

confidence: 99%

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Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials

2015

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Placebo medications and sham surgeries have long been thought to be inert treatments. These groups served as a threshold to which an active treatment should be compared in a randomized trial to determine the true efficacy of the active treatment. However, surprising changes in subjective symptom scores and objective measures of voiding have been demonstrated in numerous placebo medication or sham surgery arms of trials. The exact mechanisms by which these inactive treatments augment patient outcomes are not clearly defined and multiple theories have been proposed to explain the often pronounced response. It appears that urologic outcomes are particularly prone to these effects and the astute physician should keep these responses in mind when interpreting any trial on a new therapy.

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Section: Surgical Treatmentsmentioning

confidence: 75%

Section: Surgical Treatmentsmentioning

confidence: 89%

Section: Surgical Treatmentsmentioning

confidence: 99%

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Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials

2015

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“…McVary et al ,13 in a randomised controlled trial, compared intraprostatic injections of 200 UI BTX versus sham procedure. This study pointed out that BTX and placebo each improved International Prostate Symptom Score from baseline, but no difference was noted between treatment groups due to an exaggerated response to placebo.…”

Section: Discussionmentioning

confidence: 99%

OnabotulinumtoxinA injections in detrusor facilitate self-catheterisation in a patient with paraplegia and bladder outlet dyssynergia

2017

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This case report describes the case of improvement of clean intermittent catheterisation procedures after each intradetrusor administration of onabotulinumtoxinA in a 45-year-old man with L1 paraplegia with neurogenic detrusor overactivity and bladder outlet dyssynergia.On three occasions, improvement on clean intermittent catheterisation procedures appeared 10 to 14 days after intradetrusor injections of onabotulinumtoxinA and lasted for 9 months. We hypothesise a possible influence of intravesical injections of onabotulinumtoxinA on the storage reflex. We also discuss the possibility of a dispersion of onabotulinumtoxinA towards contiguous structures such as the urethral sphincter.

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“…Most studies describe BoNT-A injections using a transperineal approach (9,88-92,94,96) ( Table 3 ). It might be expected that the transrectal route would be associated with a high risk of infection due to bacterial contamination from rectal flora.…”

Section: Bphmentioning

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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A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of OnabotulinumtoxinA 200 U to Treat Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia

Abstract: OnabotulinumtoxinA 200 U and placebo improved I-PSS and were well tolerated but no between group difference in efficacy was observed.

Cited by 39 publications

References 14 publications

Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials

Placebo Medication and Sham Surgery Responses in Benign Prostatic Hyperplasia Treatments: Implications for Clinical Trials

OnabotulinumtoxinA injections in detrusor facilitate self-catheterisation in a patient with paraplegia and bladder outlet dyssynergia

Use of botulinum toxin for voiding dysfunction

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