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Article of the week: Botulinum toxins are not interchangeable for overactive bladder

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video of Miss Ravindra and colleagues discussing their article.

If you only have time to read one article this week, it should be this one.

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox®) or abobotulinumtoxinA (Dysport®) make a difference?

Pravisha Ravindra, Benjamin L. Jackson and Richard J. Parkinson

Nottingham Urology Centre, Nottingham University Hospitals, NHS Trust, Nottingham, UK

OBJECTIVE

• To compare the clinical effects of two different commercially available botulinum toxin type A products, onabotulinumtoxinA (Botox®; Allergan Inc., Irvine, CA, USA) and abobotulinumtoxinA (Dysport®; Ipsen Ltd, Slough, UK), on non-neurogenic overactive bladder (OAB).

PATIENTS AND METHODS

• We included 207 patients, who underwent treatment with botulinum toxin type A for non-neurogenic OAB from January 2009 to June 2012 at our institution, in a prospective database that recorded details of their presentation, treatment and outcomes.

• In December 2009, our institution switched from using onabotulinumtoxinA to using abobotulinumtoxinA.

RESULTS

• Results from the onabotulinumtoxinA cohort (n = 101) and the abobotulinumtoxinA cohort (n = 106) were compared.

• Similar reductions in daytime frequency, nocturia and incontinence episodes were observed after treatment, with no difference in duration of effect.

• The abobotulinumtoxinA cohort had almost twice the rate of symptomatic urinary retention (23 vs 42%) requiring intermittent self-catheterisation (ISC).

CONCLUSIONS

• AbobotulinumtoxinA use was complicated by a significantly higher risk of requiring ISC.

• The study suggests that these two toxins are not interchangeable at the doses used.

 

Read Previous Articles of the Week

 

Editorial: Botulinum toxin-A for overactive bladder: formulations, dosing and clean intermittent catheterisation

The article by Ravindra et al., in this issue of the BJUI, tries to address an important question of comparing the 2 commonest types of botulinum toxin-A (BTX-A), Ona- and AbobotulinumtoxinA. In their institution they changed from OnbotulinumtoxinA to AbobotulinumtoxinA and thus compared results of their different case series for patients with overactive bladder syndrome. Very few studies have tried to address this issue for botulinum toxin-A use in the urinary tract and to my knowledge there are no head to head studies. The authors found the 2 types of BTX-A equivalent in terms of voiding diary parameters, ICIQ questionnaires, patient reported global satisfaction and duration of effect but noted a significant difference for clean intermittent self catheterisation (CISC) rates (23% OnabotulinutoxinA vs 42% AbobotulinumtoxinA). The dose used for OnabotuliumtoxinA was 200 IU and for AbobotulinumtoxinA was 500 IU initially and then later 300 IU. One must bear in mind some important considerations which limit the impact of the result. Namely the non-randomised, retrospective nature of the study and the fact that the study was not designed or powered to assess the BTX-A formulations in this way. The primary endpoint in this case was a patient reported satisfaction measure indicating that 85% had ‘better’ or ‘much better’ symptoms which I think is a fair reflection in my experience. Furthermore there were significant gaps in data acquisition particularly for voiding diary, PVR and ICIQ data which again is not that uncommon in retrospective studies. No urodynamic data was included which I think may also have been interesting to look at when assessing outcomes and CISC rates.

None the less the study generates some interesting discussion about the formulations, optimal dosing and the dosing equivalence. The study is one of the first to report on the use of AbobotulinumtoxinA at 300 IU as most studies utilised 500 IU. In view of the move to lower doses of OnabotulinumtoxinA to treat refractory OAB of 100–150 IU, this dose seems appropriate. Evidence from a large dose ranging RCT using OnabotulinumtoxinA suggests no further efficacy beyond doses of 150 IU but an increase in voiding dysfunction. Interestingly CISC rates are still high at 300 IU in this study. A recent systematic review tried to assess the 2 formulations in aspects of BTX-A use for various lower urinary tract dysfunction. Due to the heterogenousity of the studies, a lack of standardised or high quality data a direct comparison between the 2 was not formally possible. It was noted that OnabotulinumtoxinA has been studied more extensively compared to AbobotulinumtoxinA and with both formulations CISC rates could be high at the doses used in this study (OnabotulinumtoxinA 43%; AbobotulinumtoxinA 35%). Assessing the compound muscle action potential of the extensor digitorum brevis muscle in healthy volunteers has suggested an AbobotulinumtoxinA to OnabotulinumtoxinA ratio of 1.57:1 (95% confidence interval: 0.77–3.20 units) with the data indicating that a dose-equivalence ratio of 3:1 was just within statistical error limits but ratios over 3:1 were too high. The same author following a review of the literature in treatments outside the urinary tract suggest a ratio of 2–2.5:1 maybe the most appropriate. An animal model of spinal cord injury and neurogenic detrusor overactivity to compare the 2 formulations has recently been published. The minimal effective dose of Abo- and OnabotulinumtoxinA was found to be 10 IU and 7.5 IU, respectively, for significant changes in cystometry.

When should CISC be instigated? Practice seems to vary considerably and thus results difficult to compare. Many clinicians will base CISC decisions on a cut off, typically 100–200 mL or on whether patients are symptomatic with their PVR. Chapple has suggested >40% of the functional capacity as a significant PVR and this to me seems entirely logical. Future studies should consider this as an endpoint regarding CISC.

At present, the decision as to which formulation is used in clinical practice is often based on local pharmacy regulation and financial considerations. Licensing is undoubtedly going to have a significant influence on this practice. OnabotulinumtoxinA is now licensed for use in many parts of the world to treat neurogenic detrsuor overactivity and has recently been approved by the FDA in the USA to treat refractory OAB. At the time of writing this editorial, no formulation is currently approved for refractory OAB in the UK.

Arun Sahai
Consultant Urologist & Honorary Senior Lecturer, Department of Urology, Guy’s Hospital MRC Centre for Transplantation, King’s College London, King’s Health Partners

Read the full article

Video: botox course the preferred choice for non-neurogenic OAB

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox®) or abobotulinumtoxinA (Dysport®) make a difference?

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Pravisha Ravindra, Benjamin L. Jackson and Richard J. Parkinson

Nottingham Urology Centre, Nottingham University Hospitals, NHS Trust, Nottingham, UK

Read the full article
OBJECTIVE

• To compare the clinical effects of two different commercially available botulinum toxin type A products, onabotulinumtoxinA (Botox®; Allergan Inc., Irvine, CA, USA) and abobotulinumtoxinA (Dysport®; Ipsen Ltd, Slough, UK), on non-neurogenic overactive bladder (OAB).

PATIENTS AND METHODS

• We included 207 patients, who underwent treatment with botulinum toxin type A for non-neurogenic OAB from January 2009 to June 2012 at our institution, in a prospective database that recorded details of their presentation, treatment and outcomes.

• In December 2009, our institution switched from using onabotulinumtoxinA to using abobotulinumtoxinA.

RESULTS

• Results from the onabotulinumtoxinA cohort (n = 101) and the abobotulinumtoxinA cohort (n = 106) were compared.

• Similar reductions in daytime frequency, nocturia and incontinence episodes were observed after treatment, with no difference in duration of effect.

• The abobotulinumtoxinA cohort had almost twice the rate of symptomatic urinary retention (23 vs 42%) requiring intermittent self-catheterisation (ISC).

CONCLUSIONS

• AbobotulinumtoxinA use was complicated by a significantly higher risk of requiring ISC.

• The study suggests that these two toxins are not interchangeable at the doses used.

Article of the Week: The botulinum toxin benefit for overactive bladder

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying blog written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

 

Long-term outcome of the use of intravesical botulinum toxin for the treatment of overactive bladder (OAB)

Amar Mohee, Ayisha Khan, Neil Harris, Ian Eardley

Read the full article
OBJECTIVES

• To assess the long-term compliance with repeated injections of intravesical botulinum toxin (BT) in a ‘real-life’ mixed population of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity.

• To identify the reasons why patients discontinued BT therapy and to explore the outcomes of those patients who did discontinue treatment.

PATIENTS AND METHODS

• Retrospective evaluation of the case notes of a series of patients who had received intravesical BT treatment at a large UK teaching hospital.

• No antibiotic prophylaxis was given for the procedure.

RESULTS

•Over a period of 7 years, 268 patients were initiated on intravesical BT treatment for overactive bladder (OAB) at our institution, with 137 followed up for ≥36 months, with 80 patients having ≥60 months follow-up after their first injection.

• Almost two-thirds of patients (61.3%) had discontinued intravesical BT therapy at 36 months, with a 63.8% discontinuation rate at 60 months.

• The main reasons for discontinuation were tolerability issues, mainly urinary tract infections and the need for clean intermittent self-catheterisation. Primary and secondary losses of efficacy were of secondary importance.

• Most of the patients that discontinued have remained under urology care and now receive alternative methods of treatment.

CONCLUSIONS

• Intravesical BT therapy is an effective short-term treatment for OAB.

• With time, two-thirds of patients discontinued treatment usually because of the tolerability issues associated with treatment.

 

Read Previous Articles of the Week

Editorial: Is botulinum toxin not the solution to OAB after all?

Dirk De Ridder
Department of Urology, University Hospital Leuven, Belgium

The article by Mohee et al. highlights a problem that is often neglected: the outomes we see in clinical trials do not predict the success of the therapy in real life. We know this from anticholinergics: the study results are good, but the performance in real life is much poorer. Only 20-40% will continue to take the medication.

For botulinum toxin in OAB it is surprising to see that even in experienced hands only 38.7% of patients continued with the treatment at 36 months. The reasons to abandon the treatment were retention, the need for CISC and urinary tract infections. Moreover, 8.6% of the patients had no response at all after the initial injection.

Of course infections could have been avoided by using prophylactic antibiotics, but the other issues remain. How to explain the primary failures? How to manage the risk of CISC?

Given the fact that most patients abandoned the treatment within the first 3 years, more research would be needed on how to increase the treatment adherence of the patients after the initial injection.

This challenging article also stresses the fact that in a time where only RCTs stand a good chance of being published in journals, good retrospective cohort studies can be extremely important too.

Read the full article
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