How to assess and predict success or failure of intra-detrusor injections with onabotulinumtoxinA

Abstract

Intra-detrusor injection therapy with onabotulinumtoxinA is generally accepted as a highly effective, minimally invasive and well-tolerated day procedure for patients with refractory overactive bladder (OAB) and neurogenic detrusor overactivity (NDO). The aim of this study was to summarize currently available methods of assessing treatment efficacy and risk factors that may influence the therapeutic effect of this approach. We found that there are discrepancies in the assessment methods. The evaluation of intra-detrusor injections with onabotulinumtoxinA in clinical trials are not always transposable into day-today practice. Moreover, the primary endpoints in clinical trials do not explore the entirety of meaningful patient-centered outcomes. Therefore, in daily clinical practice with patients with overactive bladder syndrome, the therapy should be assessed with objective measures (bladder diaries) and patient-oriented outcomes analyzing the quality of life (questionnaires). In neurogenic individuals, therapeutic efficacy should be additionally evaluated with urodynamic studies. Potential risk factors that may influence the treatment outcomes include urodynamically proven detrusor overactivity, elevated maximum detrusor pressure, greater maximum cystometric capacity, impaired bladder compliance, older age, male gender, a higher baseline bother score, previous anticholinergic treatment, and repeated injections with a subsequent decline in efficacy. The risk of intermittent catheterization following injections seems to depend on the etiology of detrusor overactivity, the injected dose, the injection technique, and the definition of significant post-void residual urine requiring catheterization.

Immunogenicity of Botulinum Toxin Formulations: Potential Therapeutic Implications

“…Following the initial priming of the adaptive immune response, repeated exposure to the antigen may result in a faster and stronger response [30,38]. In the case of biologic drug therapies, including BoNT therapy, repeated clinical exposure can potentially provoke a continual immune response and formation of nAbs, resulting in a spectrum of clinical nonresponsiveness outcomes [31,[39][40][41][42]. Common signs of clinical resistance include increasing the frequency or dose of the drug administered to elicit results, complete nonresponse, and partial nonresponse (Fig.…”

Prevalence and bother of lower urinary tract symptoms and overactive bladder in Poland, an Eastern European Study

“…Recent studies have been based on validated OAB screening instruments 18,21 . A patient's notion of help seeking and perception of OAB treatment outcome are important factors for success, but these factors are subjective and highly individual 30 . Thus, validated instruments that measure relevant symptom burden may be optimal for population-based analyses.…”

The Pharmacotherapy Time-to-Effect of Overactive Bladder Medications and Treatment Duration

“…Clinicians may underestimate the extent to which patients are affected by their symptoms in 25ñ37% of cases. Therefore, reports of medical outcomes after OAB treatment should include independent, validated questionnaires, self-administered by patients to avoid interviewer bias (40). Second, there is a significant impact of the placebo effect on OAB treatment outcomes (41).…”