Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Liposome encapsulated botulinum toxin A; Normal saline instillation
Intervention description: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day; Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Overactive bladder; Detrusor overactivity; Liposome; Botulinum toxin A

Summary:

      Overactive bladder (OAB) is a bothered symptom syndrome. Traditional medication for OAB is
      antimuscarinic agent. However, adverse events such as dry mouth, constipation, blurred
      vision, and dizziness may prohibit patient to take this drug for OAB. Intravesical botulinum
      toxin A (BoNT-A) is a novel treatment however, BoNT-A can cause acute urinary retention and
      large postvoid residual. In this grant we will evaluate liquid liposome delivery of BoNT-A
      (Liposome encapsulated BoNT-A) into the bladder without the need for cystoscopic-guided
      needle injection for refractory OAB.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults with age of 20 years old or above

          2. Patients with symptoms of urgency frequency and/or urge incontinence and a urgency
             severity scale (USS) of at least 2, with or without urodynamically proven detrusor
             overactivity (DO) (defined by the International Continence Society (ICS)
             recommendation as: spontaneous detrusor contraction occurring during bladder filling
             phase or occurring before uninhibited detrusor contraction voiding at bladder capacity
             in the urodynamic study)

          3. Free of active urinary tract infection

          4. Free of bladder outlet obstruction on enrollment

          5. Free of overt neurogenic bladder dysfunction

          6. Having been treated with antimuscarinic agents for at least 4 weeks without effect or
             with intolerable adverse effects

          7. Patient has not been treated with bladder surgery for OAB, such as enterocystoplasty,
             that might affect the therapeutic effect of test drug

          8. Patient can record voiding diary for the urinary frequency and urgency

          9. Patient or his/her legally acceptable representative has signed the written informed
             consent form

        Exclusion Criteria:

          1. Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms

          2. Patients with severe cardiopulmonary disease and such as congestive heart failure,
             arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

          3. Patients with bladder outlet obstruction on enrollment

          4. Patients with postvoid residual >150 mL

          5. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection

          6. Patients have laboratory abnormalities at screening including:

             Alanine aminotransferase (ALT) >3 x upper limit of normal range Aspartate
             aminotransferase (AST) >3 x upper limit of normal range Patients have abnormal serum
             creatinine level >2 x upper limit of normal range

          7. Patients with any contraindication to be urethral catheterization during treatment

          8. Female patients who is pregnant, lactating, or with child-bearing potential without
             contraception.

          9. Myasthenia gravis, Eaton Lambert syndrome.

         10. Patients with any other serious disease considered by the investigator not suitable
             for general anesthesia or in the condition to enter the trial

         11. Patients participated investigational drug trial within 1 month before entering this
             study