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Case Study Activity: Managing Overactive Bladder in the Community Pharmacy Answers to Interactive Questions and Resources

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Case Study Activity: Managing Overactive Bladder in the Community Pharmacy Answers to Interactive Questions and Resources Case Study Activity: Managing Overactive Bladder in the Community Pharmacy Answers to Interactive Questions and Resources Case 3: Updates on Overactive Bladder Treatments Activity Preview Overactive bladder (OAB) is a defined as “urinary urgency (except in the absence of sensory input), with or without urge incontinence, usually with frequency and nocturia” and in the absence of a known pathologic condition (uncommon) that may cause similar symptoms (e.g., urinary tract infection). When inadequately treated, OAB has a significant detrimental effect on patients’ quality of life including bothersome symptoms, inferior health-related quality of life, and higher rates of depression, anxiety, and insomnia due to nocturia and the fear of enuresis. The first-line treatment for OAB is nonpharmacologic management, consisting of lifestyle modifications, behavioral therapies (e.g., bladder and/or pelvic floor muscle training) and other toilet scheduling regimens. Anti-incontinence devices and supportive interventions are adjunctive or used to manage residual OAB symptoms. If these measures do not adequately control symptoms, pharmacotherapy with antimuscarinic medications is initiated. Antimuscarinic agents, currently the mainstay of OAB pharmacotherapy, include oxybutynin, solifenacin, darifenacin, tolterodine, trospium, and fesoterodine. These agents are available in a variety of dosage forms, ranging from transdermal patches and topical gels to oral medications (immediate-release and extended-release formulations). Still, many patients do not achieve adequate symptom relief or experience intolerable medication-related adverse events from the currently available medications. Fortunately, new treatment options for OAB with different mechanisms of action are now available. In addition, other agents, including a novel pharmacologic class of medications, are in various stages of development; the manufacturer of one of these medications has filed a New Drug Application for U.S. Food and Drug Administration (FDA) approval. Antimuscarinic Agents Oxybutynin Dosage Forms One of the first antimuscarinic agents, oxybutynin is available for administration via transdermal patch or topical gel in addition to oral forms. Like the transdermal patch formulation, the oxybutynin topical gel avoids first-pass liver metabolism of oxybutynin to the active metabolite © 2011 by the American Pharmacists Association. All rights reserved. N-desethyloxybutynin. This approach produces lower concentrations of the active metabolite, which (like the parent medication) has anticholinergic effects. Benefits of this characteristic include lower rates of the adverse anticholinergic effects of dry mouth and constipation compared with non-transdermal forms of oxybutynin, especially immediate-release oxybutynin. In contrast to the transdermal patch form of oxybutynin, the rates of local skin reactions to the gel are lower due to elimination of the patch delivery system. These improvements in tolerability are achieved while retaining the effectiveness of the oral and patch forms. Nevertheless, the same contraindications and precautions applicable to other antimuscarinics apply to the gel formulation of oxybutynin. Flexible Dosing Strategy for Antimuscarinics OAB symptoms have a variable, subjective effect on different patients. In consultation with the prescribing physician, patients have the opportunity to request increases or decreases of their medication to determine the dose that achieves the optimal balance between effectiveness and tolerability of adverse effects. In fact, this flexible dosing regimen approach has been shown to improve OAB urgency and other symptoms. Antimuscarinics that are available in multiple strengths (i.e., darifenacin, solifenacin, oxybutynin extended-release, and tolterodine), enable dose titration to patient response and therefore are candidates for flexible dosing. Patients using this approach must be cognitively intact and committed, must understand the principles of dose titration, and must be willing to assume a central role in requesting and accepting dose changes in consultation with their physician. In preparation, these patients are counseled on what to expect regarding drug effectiveness and adverse effects. They are informed of available drug strengths and encouraged to discuss the planned dose titration with their care provider. Starting with the lowest recommended dose, patients are informed that a dose increase may be needed. If intolerable adverse effects occur, patients can request a dose decrease without concern about resistance from their physician. Regardless of some improvement in the risk-to- benefit ratio using this strategy, the same contraindications and precautions apply. Antimuscarinics Alone or Combined With an α-Adrenergic Antagonist for Men Historically, antimuscarinic drugs were avoided in men with OAB symptoms and benign prostatic obstruction (BPO). This precaution was due to concern about the risk of acute urinary retention characterized by worsening voiding lower urinary tract symptoms , uncomfortable or painful effort to urinate without success, and abdominal pressure/bloating. However, recent research in this population concluded that antimuscarinic monotherapy is safe and effective in decreasing OAB symptoms and improving quality of life in men with OAB storage lower urinary tract symptoms ( see OAB Lexicon) due to primary bladder conditions (e.g., detrusor overactivity), with minimal or no voiding lower urinary tract symptoms. Conversely, antimuscarinic monotherapy is not recommended for the treatment of benign prostatic hyperplasia (BPH) without obstruction. Nor should this approach be used in men with baseline post-void residual urine volume greater than 200 mL or clinically significant bladder outlet obstruction, history of acute urinary retention due to BPH, high serum prostate-specific antigen (PSA), or low urine flow rate (as determined by urodynamic measurement). Antimuscarinic therapy may be added to α-adrenergic antagonist treatment in men with BPO and predominant OAB symptoms due to a concomitant or secondary bladder condition (e.g., BPH) or when these storage symptoms persist despite relief of voiding symptoms with an α-adrenergic antagonist alone or in combination or monotherapy with a 5-α-reductase inhibitor. However, concomitant therapy of an antimuscarinic and an α-adrenergic antagonist is not recommended for the treatment of BPH or in men with OAB symptoms with no significant bladder voiding lower urinary tract symptoms or significant bladder outlet obstruction. While the effectiveness and safety of the combined therapy does not appear to be affected by prostate size or PSA level, further research is needed to determine the effect of antimuscarinics in men with larger prostate glands or higher PSA levels. Also in need of investigation is whether criteria composed of these parameters would better identify suitable candidates for combined therapy. Therefore, while these parameters may help to guide treatment strategy, treatment should be chosen according to individual patient response. Post-void residual urine volume should be assessed before and after an antimuscarinic is started, especially during the first month of therapy. OAB Lexicon Term Definition Voiding lower urinary Slow or intermittent urinary stream, splitting or spraying, hesitancy, tract symptoms straining, terminal dribble Storage lower urinary Urinary urgency, frequency, nocturia, urinary incontinence tract symptoms BPH Benign prostatic hyperplasia BPO BPH with bladder outlet obstruction BTX-A OnabotulinumtoxinA, recently FDA-approved OAB treatment, for injection OnabotulinumtoxinA The FDA recently approved onabotulinumtoxinA (BTX-A) for injection to treat urinary incontinence due to detrusor overactivity associated with neurologic conditions such as post- stroke, spinal cord injury, and multiple sclerosis in adults inadequately controlled or intolerant of an anticholinergic medication. Two double-blind, randomized controlled trials demonstrated a significant reduction in urinary incontinence episodes and increased bladder capacity in patients who received BTX-A. Cure rates of up to 38% have been achieved after a single intradetrusor injection administered under local or general anesthesia. Although BTX-A has been shown to be effective in controlling urologic symptoms in idiopathic OAB, it is not FDA-approved for this indication at this time. BTX-A achieves its therapeutic effects in OAB by inhibiting acetylcholine and adenosine 5'-triphosphate (ATP) release at the parasympathetic presynaptic nerve terminal. The duration of BTX-A effects is approximately 9 months; repeated injections may be necessary. BTX-A does not produce anticholinergic symptoms. The most common adverse effects with BTX-A bladder injection are urinary tract infection and urinary retention. Therefore, intermittent self-catheterization may be necessary to empty the bladder in individuals who develop urinary retention and who are willing and able to perform this procedure. BTX-A has a boxed warning for the possible and potentially life-threatening distant spread of toxin effect. In addition to contraindications and precautions with other forms of BTX-A used, intradetrusor administration is contraindicated with acute urinary tract infection or urinary retention. Furthermore, BTX-A should be administered only with caution in individuals with urinary retention and only with monitoring of post-void residual urine volume in those who do not catheterize routinely,
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