overactive bladder
Conditions
Interventions
3 months administration of fesoterodine (4mg/day or 8mg/day flexibly updosed after initial 4 weeks observation)
Sponsors
Neurology, Sakura Medical Center, Toho University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject who received Informed consent and signed informed consent form. Subject has >=6 in OABSS total score and >=3 in sub score, Q3 of OABSS at screening. Subject who is moderate and more in OAB severity. Subject is male or female patients >=20 years old. Subject who reported overactive bladder symptoms 3 months or greater in duration at Visit 1. Subject who is able and willing to complete all study related assessment tools and complied with scheduled clinic visits and clinical study procedures.
Exclusion criteria
Exclusion criteria: Subject who had a known disorder that damages a spinal cord (e.g., spinal cord injury, lumbar spondylosis, spina bifida etc.). Subjects with indwelling catheter or who require the clean intermittent catheterization(CIC) Subject who had a residual urine volume (sonographic) >100 mL, or a prostate size >30 ml at Visit 1. Subject who had a complication of lower urinary tract pathology potentially responsible for urgency or incontinence (e.g., bladder stone, interstitial cystitis, urothelial tumors etc.), clinically relevant bladder outlet obstruction (e.g., benign prostatic hypertrophy etc.) Subject who had an active urinary tract infection (UTI) as shown by the results of the urinalysis at Visit 1 or recurrent urinary tract infection defined as treatment for UTI >=3 times in the last year. Subject who was known to have polyuria (>3000 mL/24h). Subject who had been treated with OAB treatment agents, such as antimuscarinic drugs within 2 weeks prior to Visit 1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of oxy-hemoglobin concentration in frontal micturition area of subjects before and after treatment with fesoterodine (from Baseline to value after 12 weeks of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of CPT in bladder afferent nerves of subjects before and after treatment with fesoterodine (from Baseline to value after 12 weeks of treatment). A multiple correlation of improving among urgency symptom, oxy-hemoglobin concentration in frontal micturition area and CPT in bladder afferent nerves in subjects before and after treatment with fesoterodine. | — |
Countries
Japan
Contacts
Public ContactRyuji Sakakibara
Sakura Medical Center, Toho University Neurology
Outcome results
None listed