UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026714 |
|---|---|
| Receipt number | R000024393 |
| Scientific Title | RCT study of bladder instillation therapy in patients with refractory interstitial cystitis. |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2017/03/27 12:27:01 |
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Basic information
Public title
RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.
Acronym
RCT study of bladder instillation therapy for refractory interstitial cystitis.
Scientific Title
RCT study of bladder instillation therapy in patients with refractory interstitial cystitis.
Scientific Title:Acronym
RCT study of bladder instillation therapy for refractory interstitial cystitis.
Region
| Japan |
Condition
Condition
Interstitial cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of bladder instillation therapy of heparin alone and combination of heparin and alkalized lidocaine in patients with interstitial cystitis. Also to assess the safety and efficacy of maintenance therapy with heparin or heparin and alkalized lidocaine combination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Global response assessment at 3rd month of maintenance therapeutic phase.
Key secondary outcomes
1. daily urinary frequency, nocturnal urinary frequency, average voided volume per urination.
2. Maximum urine flow rate, average urine flow rate, residual urine volume.
3. O'Leary & Sant's symptom score, problem score, visual analogue scale for pain, overactive bladder symptom score, international prostate symptom score
4. adverse event
at 6,12 the weeks after enrollment and 3rd,6th ,9th months at maintenance therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated with vesical instillation with heparin and alkalized lidocaine. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
Interventions/Control_2
Treated with vesical instillation with heparin alone. As introduction therapy, patients will recieve instillation every 1 to 2 weeks for six times. Then maintenance therapy follows with 6 times of monthly instillation.
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
Male and Female
Key inclusion criteria
1. Patients over 20 years old with interstitial cystitis who were diagnosed by hydrodistension at present institution.
2. Patients who are willing to participate in the study after written informed consent.
3. Patients with both OSSI and OSPI scores more than 6points and visual analogue scale for pain more than 3 points.
4. Patients who are able to be treated at outpatient.
Key exclusion criteria
1. Patients who cannot fulfill the above inclusion criteria.
2. Patients with gross hematuria.
3. Patients with lidocaine allergy.
4. Patients who are regarded not suitable for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Nomiya |
Organization
Mitsui Memorial Hospital
Division name
Department of Urology
Zip code
Address
1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
TEL
03-3862-9111
anomiya-jua@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Nomiya |
Organization
Mitsui Memorial Hospital
Division name
Department of Urology
Zip code
Address
1, Kanda-Izumicho, Chiyoda, Tokyo, 101-8643
TEL
03-3862-9111
Homepage URL
anomiya-jua@umin.ac.jp
Sponsor or person
Institute
Department of Urology, Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Mitsui Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
社会福祉法人 三井記念病院 （東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 27 | 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
| 2014 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 26 | 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
| 2017 | Year | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024393
