Urinary Bladder, Overactive
Conditions
Keywords
Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence
Brief summary
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with symptoms of overactive bladder for at least 12 weeks before the study * Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself * Subject with an average frequency of micturition of 8 or more times per 24-hour period * Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period * Subject having provided written informed consent by him/herself
Exclusion criteria
* Subject having stress urinary incontinence as a predominant symptom * Subject with transient symptoms suspected for overactive bladder * Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection * Subject complicated with bladder tumor/prostatic tumor or with the historical condition * Subject confirmed to have a post-void residual volume of \>=100ml or with a clinically significant lower urinary tract obstructive disease * Subject with indwelling catheter or practicing intermittent self-catheterization * Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia * Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study * Subject with uncontrolled hypertension (indicated by sitting SBP \>=180mmHg or DPB \>= 110mmHg) * Subject with a pulse rate \>= 110bpm or \<50 bpm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean number of micturitions per 24 hrs | Within a 12-week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Change in mean number of urinary incontinence episodes per 24 hrs | Within a 12-week treatment period |
| Change in mean number of urge incontinence episodes per 24 hrs | Within a 12-week treatment period |
| Change in mean number of urgency episodes per 24 hrs | Within a 12-week treatment period |
| Change in mean number of nocturia episodes | Within a 12-week treatment period |
| Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume | During 12-week treatment |
| Change in mean volume voided per micturition | Within a 12-week treatment period |
Countries
China, India, South Korea, Taiwan
Outcome results
None listed