UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006387 |
|---|---|
| Receipt number | R000007579 |
| Scientific Title | Clinical study on the intravesical instillation of heparin, lidocain and bicarbonate for the patients with interstitial cystitis |
| Date of disclosure of the study information | 2011/10/31 |
| Last modified on | 2011/09/21 19:14:07 |
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Basic information
Public title
Clinical study on the intravesical instillation of heparin, lidocain and bicarbonate for the patients with interstitial cystitis
Acronym
Heparin, lidocain and bicarbonate for interstitial cystitis
Scientific Title
Clinical study on the intravesical instillation of heparin, lidocain and bicarbonate for the patients with interstitial cystitis
Scientific Title:Acronym
Heparin, lidocain and bicarbonate for interstitial cystitis
Region
| Japan |
Condition
Condition
interstitital cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of the treatment with heparin, lidocaine and bicarbonate intaravesical instillation for the patients with interstitial cystitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Urinary frequency
Bladder pain
Key secondary outcomes
Flow volume chart
O'leary and Sant's symptom index and problem index
Visual analogue scale for pain
Overactive bladder symptom score
International prostate symptom score
QOL score
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
Intravesical instillation of heparin, lidocain and bicarbonate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Interstitital Cystitis
Key exclusion criteria
Patients with cystitis other than interstitial cystitis or patients with bladder neoplasms
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyo Yamamoto |
Organization
University of Tokushima
Division name
Department of Urology, Tokushima University Hospital
Zip code
Address
3-18-15, Kuramotocho, Tokushima city, Tokushima, Japan
TEL
088-633-7159
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyo Yamamoto |
Organization
University of Tokushima
Division name
Department of Urology, Tokushima University Hospital
Zip code
Address
3-18-15, Kuramotocho, Tokushima city, Tokushima, Japan
TEL
088-633-7159
Homepage URL
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2011 | Year | 10 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 21 | Day |
Last modified on
| 2011 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007579
