UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016088 |
|---|---|
| Receipt number | R000018678 |
| Scientific Title | A study on the usefulness of propiverine hydrochrorid (BUP-4)for dysuria caused to the oophorectomy followed by hysterectomy |
| Date of disclosure of the study information | 2014/12/30 |
| Last modified on | 2020/01/03 11:00:34 |
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Basic information
Public title
A study on the usefulness of propiverine hydrochrorid (BUP-4)for dysuria caused to the oophorectomy followed by hysterectomy
Acronym
A study on the usefulness of propiverine hydrochrorid (BUP-4)for dysuria caused to the uterus-oophorectomy
Scientific Title
A study on the usefulness of propiverine hydrochrorid (BUP-4)for dysuria caused to the oophorectomy followed by hysterectomy
Scientific Title:Acronym
A study on the usefulness of propiverine hydrochrorid (BUP-4)for dysuria caused to the uterus-oophorectomy
Region
| Japan |
Condition
Condition
dysuria caused to the bilateral oopholectomy followed by hysterectomy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the BUP-4 for dysuria caused to oophorectomy gollowed by hysterectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of occurrence of dysuria
Key secondary outcomes
OABSS score
KHQ score
Base
Study type
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
administration of BUP-4 20mg/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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
The patients undergone oophlectomy and hysterectomy
OABSS score :equal or more 3 (Urgency score equal or more 2)
Key exclusion criteria
Bladder cancer patients
residual urine volume equal or more 100ml
serious urine infecition
pregnancy
Breast-feeding
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Tanaka |
Organization
Keio Univercity School of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
03-3353-1211
iwatatakashi@1995.jukuin.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Iwata |
Organization
Keio Univercity School of Medicine
Division name
Obstetrics and gynecology
Zip code
Address
35 Shinanomachi Shinjyuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
iwatatakashi@1995.jukuin.keio.ac.jp
Sponsor or person
Institute
Keio Univercity School of Medicine,Department of Obstetrics and gynecology
Institute
Department
Personal name
Funding Source
Organization
Keio Univercity School of Medicine,Department of Obstetrics and gynecology
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 12 | Month | 30 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 30 | Day |
Last modified on
| 2020 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018678
