Unique ID issued by UMIN | UMIN000012712 |
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Receipt number | R000014851 |
Scientific Title | Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms |
Date of disclosure of the study information | 2014/01/06 |
Last modified on | 2013/12/27 11:45:22 |
Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms
Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms
Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms
Efficacy and safety study of flexible-dose fesoterodine on female overactive bladder symptoms
Japan |
overactive bladder (OAB)
Urology |
Others
NO
To evaluate the efficacy, the initial onset of action and patient satisfaction of flexible-dose fesoterodine on urinary urgency seen in female subjects with overactive bladder (OAB).
Safety,Efficacy
Changes from baseline in mean of urgency episodes per 24 hours after 12-week fesoterodine treatment.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Subjects receive fesoterodine 4 mg once daily for 4 weeks; thereafter, daily dosage is maintained at 4 mg or increased to 8 mg based on the subject's and physician's subjective assessment of efficacy and tolerability.
20 | years-old | <= |
80 | years-old | >= |
Female
1.female adults with moderate/severe OAB(OABSS>=6)
2.Untreated OAB patients or OAB drug washout for at least 2 weeks before starting the treatment period.
3.Obtaining of written informed consent
1.subject with the episode of urinary retention within 12 months.
2.subjects with post void residual more than 100ml.
3.subject with urinary catheter indwelled or subject under clean intermittent catheterization (CIC)
4.Acute urinary tract infection(
more than 3 times within 1 year), history of urolithiasis and interstitial cystitis.
5.Polyuria(>=3000ml/day)
6.subjects who are contraindicated for fesoterodine administration.
7.Subject considered inappropriate for participating in the study by the physician.
30
1st name | |
Middle name | |
Last name | Yasukuni Yoshimura |
Yotsuya Medical Cube
Department of Urology
7-7, Ni-bancho, Chiyoda-ku, Tokyo
03-3261-0401
yoshimura@mcube.jp
1st name | |
Middle name | |
Last name | Yasukuni Yoshimura |
Yotsuya Medical Cube
Department of Urology
7-7, Ni-bancho, Chiyoda-ku, Tokyo
03-3261-0401
yoshimura@mcube.jp
Department of Urology, Yotsuya Medical Cube
none
Self funding
NO
2014 | Year | 01 | Month | 06 | Day |
Unpublished
Preinitiation
2013 | Year | 12 | Month | 05 | Day |
2014 | Year | 03 | Month | 01 | Day |
2013 | Year | 12 | Month | 27 | Day |
2013 | Year | 12 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014851
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