Overview

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

Status:
Recruiting
Trial end date:
2020-06-01
Target enrollment:
0
Participant gender:
Female
Summary
To determine the efficacy and safety of Botulax® in treatment of Overactive Bladder
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hugel
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
Criteria
Inclusion Criteria:

1. Female at the age of 19 or older

2. Subjects who agree to participate in the clinical study and voluntarily sign the
written informed consent form

3. Subjects with idiopathic overactive bladder who meets the following conditions:

1. Subjects with persistent overactive bladder symptoms for the last 12 weeks

2. 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

3. Subjects with urinary incontinence, urgency, and urinary frequency symptoms

4. 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:

1. Subjects with the following comorbidities:

1. Subjects with peripheral motor neuron disease (eg. amyotrophic lateral sclerosis,
motor neuropathy) or systemic neuromuscular junction disorders (eg. myasthenia
gravis, Lambert-Eaton syndrome)

2. Overactive bladder patients due to neurological factors (eg stroke, spinal cord
disease, Parkinson's disease, etc.)

3. Subjects with clinically significant stress incontinence

4. Subjects with Urinary Tract Infections*

* Culture showing ≥10^5 colony-forming units (CFU)/mL and leukocytes ≥5 high
power field (HPF)

5. 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.)

6. 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)

2. Those who have had lower urinary tract surgery within 24 weeks before screening

3. Those who received botulinum toxin due to urinary system disease within 24 weeks
before screening

4. 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

5. Those who have received or plan to receive oral medications for overactive bladder
including anticholinergic drugs within 1 week prior to randomization

6. Those who received antiplatelet and anticoagulants within 1 week prior to
randomization

7. Subjects with a history of hypersensitivity reactions to any of the components of the
investigational product

8. Women of childbearing potential who are planning to become pregnant during the
clinical trials or are not using an appropriate method of contraception

9. Those who participated in another clinical trial within 12 weeks prior to screening
and received investigational product/medical device/medical procedure

10. Those who are sensitive to cephalosporin or penicillin antibiotics