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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010296
Receipt No. 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

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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&#8805;50
3) Prostate volume&#8805;20ml
4) Before administration of alpha-1 blockers, IPSS&#8805;8 and QOL score&#8805;2
5) After 4-week of more administraion of alpha-1 blockers, OABSS&#8805;3 and OABSS third question&#8805;2
Key exclusion criteria 1) Post-void residual&#8805;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
Email

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
Email

Sponsor
Institute Dept. of Urology, Kyoto University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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