UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006500 |
|---|---|
| Receipt number | R000007474 |
| Scientific Title | Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110 |
| Date of disclosure of the study information | 2011/10/11 |
| Last modified on | 2012/12/17 08:53:49 |
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Basic information
Public title
Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110
Acronym
Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110
Scientific Title
Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110
Scientific Title:Acronym
Cost-Effectiveness of Sacral Nerve Stimulation by MDT-3110
Region
| Japan |
Condition
Condition
Chronic fecal incontinence
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the cost-effectiveness of Sacral Nerve Stimulation by MDT-3110 in patients with chronic fecal incontinence
Basic objectives2
Others
Basic objectives -Others
Cost effectiveness study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incremental cost effectiveness ratio (ICER) per QALYs (Quality-adjusted life-years) gained
Key secondary outcomes
i. ICER per symptom free year
ii. ICER per symptom improved year
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients from whom written consent can be obtained.
2) Patients who are 18 years of age or older.
3) Patients who are diagnosed with chronic fecal incontinence of a duration greater than 6 months (>12 months post-vaginal childbirth). Chronic fecal incontinence is defined as >2 incontinent episodes on average per week of more than staining (a stain on undergarments or the like) recorded in the bowel diary.
Key exclusion criteria
Patients without chronic fecal incontinence
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Sakamaki |
Organization
Meijo University
Division name
Faculty of Pharmaceutical Science
Zip code
Address
150 Yagotoyama, Tempaku-ku, Nagoya
TEL
052-839-2668
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujimaro Takahashi |
Organization
Medtronic Japan Co., Ltd.
Division name
Neuromodulation
Zip code
Address
Comodio Shiodome 5F, 2-14-1 Higashi Shimbashi, Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Medtronic Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 11 | 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
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Cost effectiveness study
Management information
Registered date
| 2011 | Year | 10 | Month | 07 | Day |
Last modified on
| 2012 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007474
