UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004464 |
|---|---|
| Receipt number | R000005339 |
| Scientific Title | Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110 |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2014/06/13 12:46:04 |
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Basic information
Public title
Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110
Acronym
Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110
Scientific Title
Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using MDT-3110
Scientific Title:Acronym
Clinical Study of Sacral Nerve Stimulation Therapy in Patients with Chronic Fecal Incontinence using 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 investigate the efficacy and safety of sacral nerve stimulation therapy for fecal incontinence in a small number of subjects under actual medical situations in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy: To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent episodes per week at 6 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%).
Safety: Adverse events observed during the study will be characterized.
Key secondary outcomes
1. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent episodes per week at 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%).
2. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of incontinent days per week at 6 and 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%).
3. To investigate improvements (as compared to baseline) in the Fecal Incontinence Quality of Life at 6 and 12 months after neurostimulator implant based on the changes and the 95% confidence intervals.
4. To estimate the proportion of patients (achievement rate) with at least 50% reduction from baseline in the number of urgent incontinent bowel movements per week at 6 and 12 months after neurostimulator implant and, based on the distribution, to confirm the status of reaching the target achievement rate (>=50%).
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
| Device,equipment |
Interventions/Control_1
Long term Sacral Nerve Stimulation by implanted MDT-3110
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.
4. Patients who are failed or are not candidates for more conservative treatments.
5. Patients who are willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.
Key exclusion criteria
1. Patients with congenital anorectal malformations.
2. Patients with a present rectal prolapse.
3. Patients with a defect of external anal sphincter of >60 degrees or amenable to surgical repair.
4. Patients with a previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done less than 12 months prior to study enrollment (24 months for cancer).
5. Patients with neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e., paraplegia).
6. Patients with a grade III hemorrhoid.
7. Patients with active anal abscesses or fistulas.
8. Patients with known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
9. Patients with chronic watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence. (Incontinent episodes with a Bristol stool consistency of >=6 for >=4 days during the baseline diary period will be exclusionary, unless the investigator determines that the diary is not indicative of chronic watery diarrhea).
10. Patients who are pregnant or planned pregnancy. Patients with childbearing potential have to have a confirmed negative pregnancy test.
11. Patients with active participation in another bowel disorder investigational study.
12. Patients with a life expectancy of less than one year.
13. Patient characteristics indicating a poor understanding of the study or poor compliance with the study protocol (i.e., patients unable to adequately operate equipment, patients unwilling or unable to return for scheduled follow-up visits).
14. Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
15. Patients with anatomical limitations that would prevent the successful placement of an electrode.
16. Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
17. Patients with other implantable neurostimulators, pacemakers or defibrillators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 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
03-6430-7240
fujimaro.takahashi@medtronic.com
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
03-6430-7240
Homepage URL
fujimaro.takahashi@medtronic.com
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
社会保険中央総合病院（東京都）、医療法人財団順和会山王病院（東京都）、関西医科大学香里病院（大阪府）、高知大学医学部附属病院（高知県）、医療法人鉄蕉会亀田総合病院・亀田クリニック（千葉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jcoloproctology/67/6/67_371/_article/-char/ja/
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 | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 10 | Month | 27 | Day |
Last modified on
| 2014 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005339
