UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004554 |
|---|---|
| Receipt number | 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 18:28:28 |
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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
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
Sponsor or person
Institute
Department of Urology, Unversity of Tokyo hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005183
