This is a multicenter, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLi®) in patients with overactive bladder (OAB) . Approximately 216 subjects will be enrolled. Subjects will be randomized 2:1 to receive intradetrusor injection of Botulinus Toxin Type A for Injection (HengLi®) 100 U or placebo. The study contains two parts: core double-blinded phase and extension phase. In the core double-blinded phase, eligible subjects must attend three study visits posttreatment 12 weeks. During the extension phase, subjects must also attend three study visits (12 weeks). The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.A 3-day paper bladder diary will be used before each study visits (screening period, the second week, the sixth week, the twelfth week, the fourteenth week, the eighteenth week and the twenty fourth week ) to collect all OAB symptoms (episodes of urgency, incontinence, micturition and nocturia) and volume per voidSafety parameters will also be measured, including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
Eligible patients will be randomized on day 1 to receive double-blind treatment with Botulinus Toxin Type A for Injection (HengLi®) 100U or placebo in a 2:1 ratio. A total of 216 subjects will be randomized into this study. Followup visits will occur at day 0, week 6 and 12, and week 14, 18 and 24 thereafter until study exit at week 24 unless re-treatment was necessary. The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6. After a screening period of 1 week, all eligible patients will be randomized to receive a single intramuscular treatment with Botulinus Toxin Type A for Injection (HengLi®) or placebo at day 0 (visit 0).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
216
In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
In these studies,patients received placebo administered to 20 injection sites
average frequency of micturition
The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.
Time frame: Baseline(week -1 to 0)and core phase(week 6)
The change from baseline in the daily average frequency of urgency episodes and the scores.
The degree of urgency is divided into 5 grades (With 0 points representing no hurry, hurry on behalf of 5 points, 1\~5 points gradually increase depending on the degree of urgency)
Time frame: Baseline and Week 2,6,12,14,18,24
average frequency of UI episodes
The change from baseline in the daily average frequency of UI episodes
Time frame: Baseline and Week 2,6,12,14,18,24
volume per micturition
The change from baseline in volume voided per micturition
Time frame: Baseline and Week 2,6,12,14,18,24
maximum cystometric capacity (MCC)
The change from baseline in MCC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
Time frame: Baseline(week -1 to 0)and core phase(week 6)
maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC)
The change from baseline in PdetmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
Time frame: Baseline(week -1 to 0)and core phase(week 6)
volume at first IDC (VPmaxIDC)
The change from baseline in VPmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
Time frame: Baseline(week -1 to 0)and core phase(week 6)
The change from baseline in the QOL score
The change from baseline in the QOL score
Time frame: Baseline and Week 2,6,12,14,18,24
The change from baseline in the OABSS total summary score
The change from baseline in the OABSS total summary score
Time frame: Baseline and Week 2,6,12,14,18,24
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