Brief Summary

Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating. If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

285

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach

2 countries

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.7 years study duration

Study Start

First participant enrolled

January 1, 2002

Completed

3.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

August 30, 2011

Completed

2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

September 12, 2005

Results QC Date

April 13, 2011

Last Update Submit

January 17, 2013

Conditions

Fecal Incontinence

Keywords

Fecal IncontinenceInterStim

Outcome Measures

Primary Outcomes (1)

Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
The primary efficacy objective was to demonstrate that at least 50% of subjects will achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent episodes per week at 12 months post-implant compared to baseline are considered "successes." The observed therapeutic success rate is calculated as the proportion of implanted subjects who achieve at least 50% reduction in the number of incontinent episodes per week from baseline to twelve months.
Baseline and 12 months

Secondary Outcomes (6)

Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
Baseline and 12 months
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
Baseline and 12 Months
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
Baseline and 12 Months
+1 more secondary outcomes

Interventions

InterStim Sacral Nerve Stimulation TherapyDEVICE

Open label study. All subjects that qualify for the study will be implanted.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed and dated informed consent.
years of age or older.
Patient is diagnosed with chronic fecal incontinence of a duration greater than 6 months (\>12 months post-vaginal childbirth) and defined as \> 2 incontinent episodes on average per week of more than staining recorded during the baseline diary period.
Failed or are not candidates for more conservative treatments.
Willing and competent to completely and accurately fill out bowel diaries and questionnaires throughout the study.

You may not qualify if:

Congenital anorectal malformations.
Active participation in another bowel disorder investigational study.
Present rectal prolapse.
Previous rectal surgery (such as rectopexy or resection) or sphincteroplasty done \< 12 months prior to study enrollment (24 months for cancer).
Neurological diseases such as clinically significant peripheral neuropathy or complete spinal cord injury (i.e. paraplegia).
Grade III hemorrhoids.
Known or suspected organic disorders of the bowel (i.e. Inflammatory bowel disease such as Crohn's or ulcerative colitis).
Pregnancy or planned pregnancy.
Patients for whom patient materials are not available in a language understood by the patient.
Life expectancy of less than one year.
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).
Patients with a history of pelvic irradiation who present with visible or functional effects of irradiation.
Patients with active anal abscesses or fistulas.
Patients with anatomical limitations that would prevent the successful placement of an electrode.
Patients with knowledge of planned MRIs, diathermy, microwave, or RF energy.
+2 more criteria

Contact the study team to confirm eligibility.