Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® versus Botox® in Patient with Overactive Bladder

Inclusion criteria

• Female at the age of 19 or older
• Subjects who agree to participate in the clinical study and voluntarily sign the written informed consent form
• Subjects with idiopathic overactive bladder who meets the following conditions:

• Subjects with persistent overactive bladder symptoms for the last 12 weeks
• Subjects who are not properly controlled by the administration of anticholinergic agents for 4 weeks or more or who are difficult to treat due to adverse reactions
• Subjects with urinary incontinence, urgency, and urinary frequency symptoms
• Subjects who are willing to perform clean intermittent catheterization (CIC), if needed

Exclusion criteria

Subjects who are eligible for any of the following conditions may not participate in this study:

• Subjects with the following comorbidities:

• Subjects with peripheral motor neuron disease (eg. amyotrophic lateral sclerosis, motor neuropathy) or systemic neuromuscular junction disorders (eg. myasthenia gravis, Lambert-Eaton syndrome)
• Overactive bladder patients due to neurological factors (eg stroke, spinal cord disease, Parkinson's disease, etc.)
• Subjects with clinically significant stress incontinence
• Subjects with Urinary Tract Infections*

• Culture showing ≥10^5 colony-forming units (CFU)/mL and leukocytes ≥5 high power field (HPF)
• Patients with acute urinary retention, or with a history or accompanying diseases that can cause urinary retention (urolithiasis, acute cystitis, foreign body in the bladder, bladder flow, etc.)
• Uncontrolled diabetes patients who meet one or more of the following criteria:

• HbA1c ≥ 9% at screening
• Patients with over 10 years of diabetes
• Have diabetic chronic complications (eg diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.)
• Patients taking a drug that causes glycosuria (sodium-glucose co-transporter 2 inhibitor, SGLT2 inhibitor)
• Those who have had lower urinary tract surgery within 24 weeks before screening
• Those who received botulinum toxin due to urinary system disease within 24 weeks before screening
• Those who have been administered botulinum toxin type A within 12 weeks prior to screening or botulinum toxin type B within 16 weeks of treatment, or planned during the clinical trials
• Those who have received or plan to receive oral medications for overactive bladder including anticholinergic drugs within 1 week prior to randomization
• Those who received antiplatelet and anticoagulants within 1 week prior to randomization
• Subjects with a history of hypersensitivity reactions to any of the components of the investigational product
• Women of childbearing potential who are planning to become pregnant during the clinical trials or are not using an appropriate method of contraception
• Those who participated in another clinical trial within 12 weeks prior to screening and received investigational product/medical device/medical procedure
• Those who are sensitive to cephalosporin or penicillin antibiotics