UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019272 |
|---|---|
| Receipt number | R000022202 |
| Scientific Title | Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study |
| Date of disclosure of the study information | 2015/10/08 |
| Last modified on | 2015/10/08 08:05:48 |
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Basic information
Public title
Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Acronym
Efficacy of Mirabegron using Pressure Flow Study
Scientific Title
Efficacy and safety of Mirabegron for treatment OAB in the postmenopausal female patients -Evaluation using Pressure Flow Study
Scientific Title:Acronym
Efficacy of Mirabegron using Pressure Flow Study
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of Mirabegron for treatment OAB using Urodynamic Study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the change of storage and voiding function before and after administration
Key secondary outcomes
the change of subjective symptom (IPSS, OABSS) before and after administration
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
Mirabegron 50mg/day for 12 weeks
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
Female
Key inclusion criteria
Inclusion criteria were as follows: total OAB symptom scores (OABSS) of 3; urgency episodes 1 per week; post-menopausal women; and age 50 years.
Key exclusion criteria
Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents; had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; or had severe cardiac disease, renal dysfunction (serum-creatinine;2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
Address
65 tsurumai, Showa-ku, Nagoya
TEL
+81-52-744-2985
yoshi44@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
Address
65 tsurumai, Showa-ku, Nagoya
TEL
+81-52-744-2985
Homepage URL
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
japan
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
名古屋大学医学部附属病院泌尿器科
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 60 patients with a mean age of 72.3 years (50-86 years) were included in the analysis. The subjective symptom parameter (i.e., the mean OABSS score) decreased significantly from 9.4 to 6.2 points (p < 0.001). In objective symptom parameters, both FDV and MCC significantly improved after treatment, and DO disappeared in 14 of 35 (40.0%) patients compared to that at baseline (p < 0.01). The voiding function parameters (i.e., mean Qmax, PdetQmax, and PVR) did not significantly change, demonstrating that mirabegron does not inhibit voiding function.
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2015 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022202
