UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020778 |
|---|---|
| Receipt number | R000023984 |
| Scientific Title | Effectiveness of imidafenacin on symptoms, quality of life, and urodynamics in women with urinary incontinence associated with overactive bladder |
| Date of disclosure of the study information | 2016/01/28 |
| Last modified on | 2016/12/14 16:02:36 |
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Basic information
Public title
Effectiveness of imidafenacin on symptoms, quality of life, and urodynamics in women with urinary incontinence associated with overactive bladder
Acronym
Effectiveness of Imidafenacin for female OAB
Scientific Title
Effectiveness of imidafenacin on symptoms, quality of life, and urodynamics in women with urinary incontinence associated with overactive bladder
Scientific Title:Acronym
Effectiveness of Imidafenacin for female OAB
Region
| Japan |
Condition
Condition
Overactive bladder (OAB)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of imidafenacin on symptoms, QOL and unodynamics in women with urinary incontinence associated with OAB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of urinary incontinence episodes at 8-10 weeks after the administration
Key secondary outcomes
OABSS, ICIQ-SF, IPSS-QOL, number of urine pad exchanges, urodynamics, and incidence of adverse events
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
Imidafenacin 0.2mg/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
| Not applicable |
Gender
Female
Key inclusion criteria
1)OABSS Q3(urgency) score >=1
2)ICIQ-SF Q1(Frequency of urinary incontinence) score >=2
3)Patients from whom we have received written consent
Key exclusion criteria
1)use of prohibited drugs within the past 2 weeks
2)use of prohibited therapies within the past 8 weeks
3)presence of urinary retention
4)residual urine volume >= 100 mL
5)a urinary catheter in place or intermittent use of urethral catheterization
6)urethral stenosis, active urinary tract infection, urinary calculus, interstitial cystitis
7)serious hepatic impairment, renal impairment cardiac disease
8)pyloric/duodenal/intestinal obstruction or paralytic ileus
9)decreased gastrointestinal motility or tension
10)angle-closure glaucoma
11)severe myasthenia gravis
12)polyuria
13)severe cognitive impairment
14)lack of consenting ability
15)presence of any other conditions that required preclusion in the opinion of the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nomura |
Organization
Kameda Medical Center
Division name
Urogynecology center
Zip code
Address
929 Higashicho, Kamogawa, Chiba 296-8602 Japan
TEL
04-7092-2211
Nomusan0531@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nomura |
Organization
Kameda Medical Center
Division name
Urogynecology center
Zip code
Address
929 Higashicho, Kamogawa, Chiba 296-8602 Japan
TEL
04-7092-2211
Homepage URL
Nomusan0531@gmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
亀田メディカルセンター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 28 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 28 | Day |
Last modified on
| 2016 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023984
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| Registered date | File name |
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| Registered date | File name |
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