UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010296 |
|---|---|
| Receipt number | R000012052 |
| Scientific Title | Objective assessment of fesoterodine for overactive bladder with benign prostatic hyperplasia |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2013/03/21 19:50:06 |
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Basic information
Public title
Objective assessment of fesoterodine for overactive bladder with benign prostatic hyperplasia
Acronym
Fesoterodine for OAB with BPH
Scientific Title
Objective assessment of fesoterodine for overactive bladder with benign prostatic hyperplasia
Scientific Title:Acronym
Fesoterodine for OAB with BPH
Region
| Japan |
Condition
Condition
Overactive bladder associated with benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the impact of fesoterodine on maximal bladder capacity and detrusor pressure on voiding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of maximal bladder capacity and detrusor pressure on voiding by fesoterodine administration
Key secondary outcomes
1) Changes of other parameters of urodynamic studies
2) Changes of parameters of questionnaires
3) Changes of parameters of frequency-volume charts
4) Safety
5) Ratio of increase of fesoterodine dose
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fesoterodine 4mg~8mg/day
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Obtaining of written informed consent
2) Adult male, aged≥50
3) Prostate volume≥20ml
4) Before administration of alpha-1 blockers, IPSS≥8 and QOL score≥2
5) After 4-week of more administraion of alpha-1 blockers, OABSS≥3 and OABSS third question≥2
Key exclusion criteria
1) Post-void residual≥50ml
2) Urinary retention
3) Prostate cancer, neurogenic bladder, urethral stricture, chronic prostatitis, urinary infection, urinary tract calculi, interstitial cystitis
4) Patients who are contraindicated for fesoterodine administration
5) Within 2 weeks before entry, administration of contraindicated agents or treatments
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Yoshimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3337
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Yagi |
Organization
Kyoto University Graduate School of Medicine
Division name
Urology
Zip code
Address
TEL
075-751-3337
Homepage URL
Sponsor or person
Institute
Dept. of Urology, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation money for research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 22 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
