Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Impact of Botulinum Toxin A Versus Anticholinergic Therapy for the Treatment of Bothersome Urge Urinary Incontinence
Brief Summary: Urinary incontinence is a prevalent condition that markedly impacts quality of life and disproportionately affects women. Overactive Bladder syndrome (OAB) is defined as symptoms of urgency and frequency with urge urinary incontinence (OAB-wet) and without urge incontinence (OAB-dry). Conservative first line treatments for urge incontinence combined with other OAB symptoms (OAB-wet) include behavioral therapy, pelvic floor training +/- biofeedback, or the use of anticholinergic medications. These treatment modalities may not result in total continence and often drug therapy is discontinued because of lack of efficacy, side effects and cost or because of not wanting to take a pill. Behavioral therapy and pelvic muscle exercises require consistent, active intervention by the patient which is often not sustained. Thus, the objective of the Anticholinergic vs Botox Comparison Study (ABC) is to determine whether a single intra-detrusor injection of botulinum toxin A (Botox A®) is more effective than a standardized regimen of oral anticholinergics in reducing urge urinary incontinence. The null hypothesis is that there is no difference in the change from baseline in average number of urge urinary incontinence episodes over 6 months between groups.


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: DA-8010 Placebo, Drug: Solifenacin succinate placebo | Arm Label: DA-8010 2.5mg; Type: EXPERIMENTAL; Interventions: Drug: DA-8010 2.5mg, Drug: Solifenacin succinate placebo | Arm Label: DA-8010 5mg; Type: EXPERIMENTAL; Interventions: Drug: DA-8010 5mg, Drug: Solifenacin succinate placebo | Arm Label: Solifenacin 5mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: DA-8010 Placebo, Drug: Solifenacin 5mg | Intervention Type: DRUG; Name: DA-8010 Placebo; Assigned to Arm(s): Placebo, Solifenacin 5mg | Intervention Type: DRUG; Name: DA-8010 2.5mg; Assigned to Arm(s): DA-8010 2.5mg | Intervention Type: DRUG; Name: DA-8010 5mg; Assigned to Arm(s): DA-8010 5mg | Intervention Type: DRUG; Name: Solifenacin 5mg; Assigned to Arm(s): Solifenacin 5mg | Intervention Type: DRUG; Name: Solifenacin succinate placebo; Assigned to Arm(s): DA-8010 2.5mg, DA-8010 5mg, Placebo
B: Arm Label: Botox A; Type: EXPERIMENTAL; Interventions: Drug: Botulinum toxin A (Botox A®) | Arm Label: Standardized Anticholinergic Regimen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Solifenacin 5mg, Drug: Solifenacin 10mg, Drug: Trospium chloride | Intervention Type: DRUG; Name: Botulinum toxin A (Botox A®); Assigned to Arm(s): Botox A | Intervention Type: DRUG; Name: Solifenacin 5mg; Assigned to Arm(s): Standardized Anticholinergic Regimen | Intervention Type: DRUG; Name: Solifenacin 10mg; Assigned to Arm(s): Standardized Anticholinergic Regimen | Intervention Type: DRUG; Name: Trospium chloride; Assigned to Arm(s): Standardized Anticholinergic Regimen
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tolterodine ER | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Fesoterodine | Intervention Type: DRUG; Name: Tolterodine ER; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Fesoterodine; Assigned to Arm(s): 3
D: Arm Label: 1: Solifenacin 5 mg + Mirabegron 25 mg; Type: EXPERIMENTAL; Interventions: Drug: Solifenacin succinate, Drug: Mirabegron, Drug: Placebo to match mirabegron | Arm Label: 2: Solifenacin 5 mg + Mirabegron 50 mg; Type: EXPERIMENTAL; Interventions: Drug: Solifenacin succinate, Drug: Mirabegron, Drug: Placebo to match mirabegron | Arm Label: 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to match solifenacin succinate, Drug: Placebo to match mirabegron | Arm Label: 4: Solifenacin 5 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Solifenacin succinate, Drug: Placebo to match mirabegron | Arm Label: 5:Mirabegron 25 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mirabegron, Drug: Placebo to match solifenacin succinate, Drug: Placebo to match mirabegron | Arm Label: 6: Mirabegron 50 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mirabegron, Drug: Placebo to match solifenacin succinate, Drug: Placebo to match mirabegron | Intervention Type: DRUG; Name: Solifenacin succinate; Assigned to Arm(s): 1: Solifenacin 5 mg + Mirabegron 25 mg, 2: Solifenacin 5 mg + Mirabegron 50 mg, 4: Solifenacin 5 mg | Intervention Type: DRUG; Name: Mirabegron; Assigned to Arm(s): 1: Solifenacin 5 mg + Mirabegron 25 mg, 2: Solifenacin 5 mg + Mirabegron 50 mg, 5:Mirabegron 25 mg, 6: Mirabegron 50 mg | Intervention Type: DRUG; Name: Placebo to match solifenacin succinate; Assigned to Arm(s): 3: Placebo, 5:Mirabegron 25 mg, 6: Mirabegron 50 mg | Intervention Type: DRUG; Name: Placebo to match mirabegron; Assigned to Arm(s): 1: Solifenacin 5 mg + Mirabegron 25 mg, 2: Solifenacin 5 mg + Mirabegron 50 mg, 3: Placebo, 4: Solifenacin 5 mg, 5:Mirabegron 25 mg, 6: Mirabegron 50 mg

Answer: B