UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020778
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email Nomusan0531@gmail.com

Sponsor
Institute Kameda Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.