UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004464
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email fujimaro.takahashi@medtronic.com

Public contact
1st 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
Email fujimaro.takahashi@medtronic.com

Sponsor
Institute Medtronic Japan Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005339

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.