Status:
COMPLETED
Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence, usually no metabolic or anatomical disorders can be found and it may have great ...
Eligibility Criteria
Inclusion
- Adults with age of 20 years old or above
- 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)
- Free of active urinary tract infection
- Free of bladder outlet obstruction on enrollment
- Free of overt neurogenic bladder dysfunction
- Having been treated with antimuscarinic agents for at least 4 weeks without effect or with intolerable adverse effects
- Patient has not been treated with bladder surgery for OAB, such as enterocystoplasty, that might affect the therapeutic effect of test drug
- Patient can record voiding diary for the urinary frequency and urgency
- Patient or his/her legally acceptable representative has signed the written informed consent form
Exclusion
- Use of antimuscarinic agent and effective in treatment of lower urinary tract symptoms
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with bladder outlet obstruction on enrollment
- Patients with postvoid residual \>150 mL
- Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
- 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
- Patients with any contraindication to be urethral catheterization during treatment
- Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
- Myasthenia gravis, Eaton Lambert syndrome.
- Patients with any other serious disease considered by the investigator not suitable for general anesthesia or in the condition to enter the trial
- Patients participated investigational drug trial within 1 month before entering this study
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01167257
Start Date
May 1 2010
End Date
December 1 2013
Last Update
September 22 2014
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 970