Phase 2
N=62
Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Overactive Bladder
Bottom Line
View on ClinicalTrials.gov: NCT01167257 ↗Enrolled (actual)
62
Serious AEs
4.8%
Results posted
Sep 2014
Primary outcome: Primary: Mean Change of the Total Frequency Per 3 Days — -4.64; -0.19 Frequency per 3 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liposome encapsulated botulinum toxin A (Drug); Normal saline instillation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Buddhist Tzu Chi General Hospital
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change of the Total Frequency Per 3 Days |
-4.64; -0.19 | — |
| SECONDARY Mean Change of the Urgency Episodes Per 3 Days |
-7.43; -3.43 | — |
| SECONDARY Mean Change of the Urgency Urinary Incontinence (UUI) Per 3 Days |
0.43; 0.56 | — |
| SECONDARY Net Change of the Overactive Bladder Symptom Score (OABSS) |
-1.86; -0.75 | — |
| SECONDARY Net Change of the Functional Bladder Capacity (FBC) |
-12.86; 18.15 | — |
| SECONDARY Net Change of the Maximum Flow Rate (Qmax) |
0.11; -0.84 | — |
| SECONDARY Net Change of the Postvoid Residual Volume (PVR) |
-2.65; -2.31 | — |
| SECONDARY Net Change of the Urgency Severity Score (USS) Within 3 Days |
11; 4; 16; 20; 1; 4 | — |
| SECONDARY Net Change of the Global Response Assessment (GRA) |
21; 19; 7; 9 | — |
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
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01167257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.