Christopher Dowson

Repeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

BACKGROUND Efficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO). OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO. DESIGN, SETTING, AND PARTICIPANTS Prospective data from a single centre were collected from the first 100 patients. INTERVENTION Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting. MEASUREMENTS OAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate. RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)-related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients. CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

Voiding DysfunctionRepeated Botulinum Toxin Type A Injections for Refractory Overactive Bladder: Medium-Term Outcomes, Safety Profile, and Discontinuation Rates

BACKGROUND Efficacy and safety of botulinum toxin type A (BoNTA) injection is supported by level 1 evidence, but data regarding repeated injections are limited in patients with refractory overactive bladder (OAB) and idiopathic detrusor overactivity (IDO). OBJECTIVES Describe medium-term outcomes and discontinuation rates for patients adopting repeated BoNTA as a management strategy for IDO. DESIGN, SETTING, AND PARTICIPANTS Prospective data from a single centre were collected from the first 100 patients. INTERVENTION Bladder injection of BoNTA (predominantly 200 U onabotulinumtoxinA; Allergan Ltd., Marlow, Buckinghamshire, UK) in an outpatient setting. MEASUREMENTS OAB symptoms, quality of life, discontinuation rates, interinjection interval, and adverse events were recorded. Data comparisons were performed using a generalised linear model or a chi-square test where appropriate. RESULTS AND LIMITATIONS Two hundred seven injections were performed in 100 patients. All patients had 1 injection, 53 had a total of 2, 20 had 3, 13 had 4, 10 had 5, 5 had 6, 3 had 7, 1 had 8, 1 had 9, and 1 had 10 injections. Statistics were applied up to five repeated injections. A statistically significant reduction in frequency, urgency, and urge urinary incontinence were seen following the first BoNTA injection compared to baseline. This improvement was maintained after repeated injections and was not statistically different when comparing differences between injections. Thirty-seven patients stopped treatment after the first two injections; thereafter, dropouts were rare. The most common reasons for discontinuing treatment were poor efficacy (13%) and clean intermittent self-catheterisation (CISC)-related issues (11%). The incidence of CISC after the first injection was 35%. Bacteriuria was detected in 21% of patients. The mean interinjection interval was 322 d. Limitations included the concurrent use of antimuscarinic drugs in some patients. CONCLUSIONS BoNTA can provide a safe and effective medium-term management option for patients with refractory IDO. The most common reasons cited for stopping treatment were poor efficacy and CISC-related issues.

Repeated injections of botulinum toxin-A for idiopathic detrusor overactivity.

OBJECTIVES To report the efficacy and safety of repeated injections of botulinum toxin-A (BTX-A) in treating idiopathic detrusor overactivity refractory to anticholinergics. Furthermore, we describe whether dose alteration in patients with poor responses or voiding dysfunction after initial treatment can improve outcomes. METHODS A cohort of 34 patients who participated in a clinical trial was followed up and their progress reported. Twenty from this group had >1 BTX-A injection. Each patient received 200 U BTX-A initially, with subsequent injections between 100 and 300 U, administered by a trigone-sparing flexible cystoscopic technique. Efficacy was measured using voiding diaries and quality of life (QoL) assessed with Incontinence Impact Questionnaire-7 and Urogenital Distress Inventory-6 questionnaires. Urodynamic data were obtained for injections 1-3. All measurements were performed before and 3 months after injections. RESULTS Twenty patients received a repeat injection and of these 9 subsequently received a third and fourth injection. Significant improvements in overactive bladder syndrome symptoms and QoL were observed after each injection as compared with baseline. Maximum cystometric capacity and bladder compliance increased with decrease in the maximum detrusor pressure during filling cystometry. When comparing overactive bladder symptoms, QoL, and urodynamic parameters 3 months after the first and last injections, no significant differences were found. Nine patients had their BTX-A dose altered, with better outcomes in 5. The commonest reported problems were difficulty in emptying the bladder and urinary tract infection. CONCLUSIONS BTX-A appears to be effective and safe after repeated administration in patients with idiopathic detrusor overactivity. Certain patients will benefit from dose optimization to improve efficacy or prevent voiding dysfunction.

Improvement in quality of life after botulinum toxin―A injections for idiopathic detrusor overactivity: results from a randomized double―blind placebo―controlled trial

To determine whether botulinum toxin‐A (BTX‐A) treatment has an effect on the quality of life (QoL) of patients with overactive bladder (OAB) refractory to anticholinergics.

The safety and efficacy of botulinum toxin-A in the management of bladder oversensitivity: a randomised double-blind placebo-controlled trial

Objective:  To assess the safety and efficacy of botulinum toxin‐A (botn‐A) in the management of patients with bladder oversensitivity (BO).

Repeat botulinum toxin-A injections for treatment of adult detrusor overactivity

Intravesical injections of botulinum toxin-A have become established as an effective therapy in the management of neurogenic and idiopathic detrusor overactivity that is refractory to treatment with anticholinergic medication. The effects of the toxin are finite and repeated injections are required to sustain the beneficial therapeutic effects. The available data suggest a reproducible and sustained improvement in symptoms as well as urodynamic parameters following repeated injections of botulinum toxin-A. The reported incidence of adverse events is low and resistance to the toxin is uncommon. The timing of repeat injections within the published data is variable, reflecting differing practise among clinicians, but is typically 6–12 months. Larger scale studies are still required to clarify the usefulness of botulinum toxin-A as a long-term treatment in the management of detrusor overactivity.

Validation of the bladder control self‐assessment questionnaire (B‐SAQ) in men

To validate the Bladder Control Self‐Assessment Questionnaire (B‐SAQ), a short screener to assess lower urinary tract symptoms (LUTS) and overactive bladder (OAB) in men.

Botulinum toxin-A for the treatment of overactive bladder: UK contributions.

Background: Botulinum toxin-A (BoNT/A) is now established second-line management for refractory overactive bladder (OAB) and recognised in many incontinence guidelines and pathways. For those with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis, the toxin is currently licensed in certain parts of the world, including the UK. It is an effective treatment in those in whom antimuscarinics and conservative measures have failed who have symptoms of OAB and or detrusor overactivity (DO). Methods: Treatment can be given in an outpatient setting and can be administered under local anaesthesia. Its efficacy lasts for between six and 12 months. Results: It has an acceptable safety profile with the biggest risk being urinary tract infection and difficulty emptying the bladder, necessitating clean intermittent self-catheterisation (CISC). Medium-term follow-up suggests repeated injections are also safe and efficacious. Conclusions: The mechanism of action of the toxin is more complicated than originally thought, and it seems likely that it affects motor and sensory nerves of the bladder. In the last 10 years much of the progress of this treatment from early experimental trials to mainstream clinical use, and a better understanding of how it works in the bladder, are as a result of research conducted in the UK. This review summarises the significant and substantial evidence for BoNT/A to treat refractory OAB from UK centres.

Botulinum toxin-A for the treatment of overactive bladder: UKcontributions

Background: Botulinum toxin-A (BoNT/A) is now established second-line management for refractory overactive bladder (OAB) and recognised in many incontinence guidelines and pathways. For those with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis, the toxin is currently licensed in certain parts of the world, including the UK. It is an effective treatment in those in whom antimuscarinics and conservative measures have failed who have symptoms of OAB and or detrusor overactivity (DO). Methods: Treatment can be given in an outpatient setting and can be administered under local anaesthesia. Its efficacy lasts for between six and 12 months. Results: It has an acceptable safety profile with the biggest risk being urinary tract infection and difficulty emptying the bladder, necessitating clean intermittent self-catheterisation (CISC). Medium-term follow-up suggests repeated injections are also safe and efficacious. Conclusions: The mechanism of action of the toxin is more complicated than originally thought, and it seems likely that it affects motor and sensory nerves of the bladder. In the last 10 years much of the progress of this treatment from early experimental trials to mainstream clinical use, and a better understanding of how it works in the bladder, are as a result of research conducted in the UK. This review summarises the significant and substantial evidence for BoNT/A to treat refractory OAB from UK centres.

Botulinum toxin-A for the treatment of overactive bladder

Background: Botulinum toxin-A (BoNT/A) is now established second-line management for refractory overactive bladder (OAB) and recognised in many incontinence guidelines and pathways. For those with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis, the toxin is currently licensed in certain parts of the world, including the UK. It is an effective treatment in those in whom antimuscarinics and conservative measures have failed who have symptoms of OAB and or detrusor overactivity (DO). Methods: Treatment can be given in an outpatient setting and can be administered under local anaesthesia. Its efficacy lasts for between six and 12 months. Results: It has an acceptable safety profile with the biggest risk being urinary tract infection and difficulty emptying the bladder, necessitating clean intermittent self-catheterisation (CISC). Medium-term follow-up suggests repeated injections are also safe and efficacious. Conclusions: The mechanism of action of the toxin is more complicated than originally thought, and it seems likely that it affects motor and sensory nerves of the bladder. In the last 10 years much of the progress of this treatment from early experimental trials to mainstream clinical use, and a better understanding of how it works in the bladder, are as a result of research conducted in the UK. This review summarises the significant and substantial evidence for BoNT/A to treat refractory OAB from UK centres.