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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004554
Receipt No. R000005183
Scientific Title Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Date of disclosure of the study information 2010/11/15
Last modified on 2016/02/22

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Basic information
Public title Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Acronym Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Scientific Title Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Scientific Title:Acronym Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Region
Japan

Condition
Condition Interstitial cystitis/ Painful bladder syndrome (IC/ PBS)
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect and safety of intravesical instillaion of 100IU of botulinum toxin A in patients with IC/ PBS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Subjects are randomized into 2 groups;one is group who will be treated soon after the enrollment, the other will be observed with present therapy for a month, then treated.
The primary end point of this study will be the Global response assessment score in these two groups.
Key secondary outcomes 1.Duration of symptom relief
2.Changes during 12 months after the therapy
1)flow volume chart
2)O'Leary and Sants' symptom index and problem index
3)Visual analogue scale for pain
4)over active bladder symptom score
5)International prostate symptom score
6)Core lower urinary tract symptom score
7)QOL score
8)Global response assessment score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Subjects will be treated soon after the randomization, then will have monthly follow up for 12months.
Interventions/Control_2 Subjects will be observed for a month with present therapy, then have BTX treatment. After the therapy, they will have monthly follow up for 12 months.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. IC/ PBS patients whose age is between 20 and 80 years.
2. Those who can have informed consent.
3. Those whose VAS score is more than 4 points and both OSSI/ OSPI scores are more than 6 points despite of hydrodistension, oral administration and intravesical therapy at present institution.
Key exclusion criteria 12
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Nomiya
Organization University of Tokyo
Division name Department of Urology, Graduate school of medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL 03-5800-8753
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo
Division name Department of Urology, Graduate school of medicine
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan.
TEL 03-5800-8753
Homepage URL
Email

Sponsor
Institute Department of Urology, Unversity of Tokyo hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding 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 東京大学医学部附属病院泌尿器科(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/iju.12833/epdf
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
2010 Year 06 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 13 Day
Last modified on
2016 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005183

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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