OBJECTIVE 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. PATIENTS AND METHODS This was a single centre, randomized, double‐blind, placebo‐controlled trial. Participants were men and women with idiopathic detrusor overactivity (IDO). Participants were randomised to receive either 200 U of BTX‐A (Botox®, Allergan Inc., Irvine, CA, USA; n = 16) or placebo (n = 18) via a trigone‐sparing flexible cystoscopic technique. QoL was assessed using the King’s Health Questionnaire (KHQ) at baseline and at 4 and 12 weeks, after injection. At 12 weeks patients were ‘unblinded’ and a further open‐label follow‐up in the BTX‐A group occurred at 24 weeks. The changes in the subdomains of the KHQ were assessed over the study period. RESULTS Overall QoL was significantly improved in the BTX‐A treated patients compared with placebo in the blinded part of the study. When analysing the KHQ subdomains, ‘Incontinence Impact’, ‘Emotions’, ‘Physical Limitations’, ‘Social Limitations’ and ‘Severity Measures’ were significantly improved in those that received BTX‐A compared with placebo. The ‘Symptom Severity’ domain was also significantly improved at 4 weeks but not at 12 weeks. At 12 weeks ‘Role Limitations’ also became statistically significant in favour of BTX‐A. The open‐label extension study suggested these benefits last for at least 24 weeks. CONCLUSIONS BTX‐A bladder injections at 200 U appear to improve QoL in patients with OAB symptoms and IDO refractory to anticholinergics for at least 24 weeks. As well as the improvement seen in clinical parameters with this form of therapy, perhaps of more importance to the patient, is the improvement in QoL.
Objective• 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. Patients and Methods• This was a prospective, single-centre study including 211 patients in a urology outpatient setting.• All patients completed the B-SAQ and Kings Health Questionnaire (KHQ) before consultation, and the consulting urologist made an independent assessment of LUTS and the need for treatment.• The psychometric properties of the B-SAQ were analysed. Results• A total of 98% of respondents completed all items correctly in <5 min.• The mean B-SAQ scores were 12 and 3.3, respectively for cases (n = 101) and controls (n = 108) (P < 0.001).• Good correlation was evident between the B-SAQ and the KHQ.• The agreement percentages between the individual B-SAQ items and the KHQ symptom severity scale were 86, 85, 84 and 79% for frequency, urgency, nocturia and urinary incontinence, respectively.• Using a B-SAQ symptom score threshold of ≥4 alone had sensitivity, specificity and positive predictive values for detecting LUTS of 75, 86 and 84%, respectively, with an area under the curve of 0.88; however, in combination with a bother score threshold of ≥1 these values changed to 92, 46 and 86%, respectively. Conclusions• The B-SAQ is an easy and quick valid case-finding tool for LUTS/OAB in men, but appears to be less specific in men than in women.• The B-SAQ has the potential to raise awareness of LUTS.• Further validation in a community setting is required.
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.
Objective To evaluate the patient experience of our dedicated botulinum toxin A (BTX‐A) service using a validated patient‐reported experience measure (PREM) and assess patient‐reported satisfaction with treatment. Materials and Methods The first 100 patients who underwent BTX‐A treatment for refractory idiopathic detrusor overactivity (IDO) in our institution were contacted for telephone interview. They had all been assessed, injected and followed up in a dedicated BTX‐A clinic. Patients were asked to complete a validated PREM – the Client Satisfaction Questionnaire (CSQ‐8) – as well as a questionnaire developed in our department to assess satisfaction with the results of the treatment. Most patients received 200 U OnabotulinumtoxinA (Botox®) via an outpatient local anaesthetic flexible cystoscopy technique. Results Complete data was available for 72 patients. In all, 49 patients were continuing to receive BTX‐A treatment while 23 had opted for no further injections. The overall mean (sd) CSQ‐8 satisfaction score was 38.3 (3.3), indicating a high level of patient satisfaction with the service offered in our institution. There was a significant difference in total satisfaction scores between those still receiving BTX‐A (mean score 29.8) and those who have discontinued treatment (mean score 25.1) (P < 0.01). Overall patient satisfaction with the result of the treatment was high with an overall mean (sd) score of 8.6 (2.0) on a visual analogue scale. Of those who had discontinued BTX‐A, most were either using conservative measures only (44%) or had recommenced anticholinergic medications. Conclusion Overall patient satisfaction with the dedicated BTX‐A service offered in our institution is high and can result in a positive patient experience. The use of PREMs are advocated in order to fully capture the patient's views of the quality of services and treatments they receive.
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.
Overactive bladder (OAB) syndrome affects millions of people worldwide. In addition to adversely affecting quality of life, the direct and indirect costs in managing patients with OAB incur a substantial financial burden on health services. Among the approved anticholinergics for treating OAB, oxybutynin is the most extensively studied drug in clinical trials. The principle metabolite of oxybutynin has a higher affinity for muscarinic receptors in salivary glands which lead to significantly high dry mouth rates. This prompted the development of alternative formulations of oxybutynin aiming to achieve better tolerability whilst sustaining efficacy. This editorial examines the efficacy and tolerability of transdermal oxybutynin (OXY-TD) in treating OAB. Articles were retrieved from PubMed between 2000 to the present day relating to OXY-TD. Data is presented from phase I-IV trials. The results from placebo-controlled trials indicate that OXY-TD is efficacious in treating patients with OAB associated with urge urinary or mixed incontinence. Systemic side effects most notably dry mouth, appear to be less with this formulation compared with oral anticholinergics. However, further study is required in different OAB populations. The main limitation appears to be related to application site adverse events such as pruritus and erythema. OXY-TD is likely to find its place as first-line pharmacotherapy in the clinicians' armamentarium in treating OAB.
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