UMIN-CTR Clinical Trial

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

Chronic Fecal Incontinence

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO

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

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%).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Medtronic Japan Co., Ltd.

Institute

Department

Personal name

Organization

Medtronic Japan Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2010

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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