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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036799
Receipt No. R000041913
Scientific Title Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Date of disclosure of the study information 2019/07/01
Last modified on 2019/05/17

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Basic information
Public title Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Acronym Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Scientific Title Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Scientific Title:Acronym Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Region
Japan

Condition
Condition Benign Prostatic Hyperplasia
Overactive Bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate useful predictors of add-on therapy for overactive bladder symptoms in male lower urinary tract symptoms
Basic objectives2 Others
Basic objectives -Others Uroflowmetry, ultrasonography, the 24-h frequency-volume charts are used to study predictors of add-on therapy for overactive bladder symptoms in male lower urinary tract symptoms
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The factors associated with residual overactive bladder symptoms eight weeks after the start of add-on therapy in male lower urinary tract symptoms patient
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >
Gender Male
Key inclusion criteria The patient with lower urinary tract symptoms and benigh prostatic hyperplasia (Prostate volume is over 20mL.)
Key exclusion criteria We excluded the patient had urinary tract infection, suspected urinary tract malignancy, treatment history of urinary tract malignancy and urinary tract surgery history.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshiyuki
Middle name
Last name Kojima
Organization Fukushima Medical University School of Medicine
Division name Department of Urology
Zip code 960-1295
Address 1-Hikarigaoka, Fukushima
TEL 024-547-1316
Email urol@fmu.ac.jp

Public contact
Name of contact person
1st name Kanako
Middle name
Last name Matsuoka
Organization Fukushima Medical University School of Medicine
Division name Department of Urology
Zip code 960-1295
Address 1-Hikarigaoka, Fukushima
TEL 024-547-1316
Homepage URL
Email kanaco@fmu.ac.jp

Sponsor
Institute Department of Urology, Fukushima Medical University School of Medicine
Institute
Department

Funding Source
Organization Fukushima Medical University
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 Fukushima Medical University School of Medicine
Address 1-Hikarigaoka, Fukushima
Tel 024-547-1316
Email kanaco@fmu.ac.jp

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
2019 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 19 Day
Date of IRB
2019 Year 01 Month 28 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information Design:Cohort Study
Recruitment:All patients who visited our facility or collaborative research facility, and met our selection criteria in April-2022 March 2019.

Management information
Registered date
2019 Year 05 Month 20 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041913

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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