Clinical Trial: Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Medtronic InterStim® Sacral Nerve Stimulation Therapy for Bowel Control: Fecal Incontinence Study

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.


Detailed Summary:
Sponsor: MedtronicNeuro

Current Primary Outcome: Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ]

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.



Original Primary Outcome: Reduction in the number of incontinent episodes per week

Current Secondary Outcome:

  • Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week [ Time Frame: Baseline and 12 months ]

    This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of incontinent days per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of fecal incontinent days 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 days per week from baseline to twelve months.

  • Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle [ Time Frame: Baseline and 12 months ]
    This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
  • Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior [ Time Frame: Baseline and 12 Months ]
    This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
  • Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception [ Time Frame: Baseline and 12 Months ]
    This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
  • Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment [ Time Frame: Baseline and 12 Months ]
    This secondary efficacy objective was to demonstrate improvement in Fecal Incontinence Quality of Life (FIQOL) scores at 12 months post-implant compared to baseline. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. The four component scales of the FIQOL instrument were evaluated separately.
  • Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week [ Time Frame: Baseline and 12 months ]

    This secondary objective was to demonstrate that at least 50% of subjects achieved at least 50% reduction in the number of urgent incontinent episodes per week at 12 months post-implant compared to baseline. Subjects who achieve at least 50% reduction in the number of urgent 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 urgent incontinent episodes per week from baseline to 12 months.



Original Secondary Outcome:

  • Reduction in the number of incontinent days per week
  • Improvement in quality of life
  • Reduction in urgent incontinent bowel movements


Information By: MedtronicNeuro

Dates:
Date Received: September 12, 2005
Date Started: January 2002
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013