Fesoterodine ameliorates the activity in frontal brain micturition area and the hypersensibility of bladder afferent nerves in patients with OAB symptoms.
- Conditions
- overactive bladder
- Registration Number
- JPRN-UMIN000013084
- Lead Sponsor
- eurology, Sakura Medical Center, Toho University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 53
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.