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Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence

This study has been completed.
Sponsor:
Information provided by:
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00200057
First received: September 12, 2005
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
Results First Received: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Fecal Incontinence
Intervention: Device: InterStim Sacral Nerve Stimulation Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The clinical investigation began on January 14, 2002, and the first implant occurred on May 03, 2002. The study was closed to enrollments on June 15, 2006, and the last implant occurred on August 04, 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients who signed an informed consent were considered enrolled in the study. Of the 285 subjects who enrolled in the study, 132 subjects underwent acute test stimulation with 129 proceeding to the sub-chronic test stimulation phase. Of these, 120 subjects qualified for permanent implant. All 120 patients were successfully implanted.

Reporting Groups
  Description
Implanted Subjects Subjects implanted with Sacral Nerve Stimulation (SNS) device.

Participant Flow:   Overall Study
    Implanted Subjects  
STARTED     120  
1 Month Follow-up     117  
3 Month Follow-up     116  
6 Month Follow-up     114  
12 Month Follow-up     111  
COMPLETED     111  
NOT COMPLETED     9  
Lack of Efficacy                 3  
Exited due to terminal illness of PI                 2  
Withdrawal by Subject                 1  
Change in medical condition                 1  
Infection                 1  
Death                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Implanted Subjects Subjects implanted with Sacral Nerve Stimulation (SNS) device.

Baseline Measures
    Implanted Subjects  
Number of Participants  
[units: participants]
 		  120  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     71  
>=65 years     49  
Age  
[units: years]
Mean ± Standard Deviation 		  60.5  ± 12.5  
Gender  
[units: participants]
 		 
Female     110  
Male     10  
Region of Enrollment  
[units: participants]
 		 
United States     87  
Canada     19  
Australia     14  
Weekly Fecal Incontinent Episodes [1]
[units: incontinent episodes per week]
Mean ± Standard Deviation 		  9.39  ± 7.27  
Weekly Fecal Incontinent Days [2]
[units: incontinent days per week]
Mean ± Standard Deviation 		  4.51  ± 1.61  
Weekly Urgent Fecal Incontinent Episodes [3]
[units: urgent incontinent episodes per week]
Mean ± Standard Deviation 		  4.95  ± 4.88  
Fecal Incontinence Quality of Life (FIQOL) Scale 1 - Lifestyle [4]
[units: units on a scale]
Mean ± Standard Deviation 		  2.31  ± 0.85  
FIQOL Scale 2 - Coping/Behavior [5]
[units: units on a scale]
Mean ± Standard Deviation 		  1.49  ± 0.53  
FIQOL Scale 3 - Depression/Self-Perception [5]
[units: units on a scale]
Mean ± Standard Deviation 		  2.53  ± 0.81  
FIQOL Scale 4 - Embarrassment [5]
[units: units on a scale]
Mean ± Standard Deviation 		  1.60  ± 0.63  
[1] A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling.
[2] A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each bowel episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A day in a diary period was considered as an incontinent day if there was at least one incontinent episode during that day.
[3] A bowel diary was used by subjects to record information about their bowel elimination frequency. Over the 14-day diary period, subjects recorded the date and time of each bowel episode and responded to questions related to each episode, including amount of incontinence (none, staining, minor soiling, major soiling) and urgency (no, yes). A bowel movement was considered incontinent if the amount of incontinence was minor or major soiling. A bowel movement was considered urgent if the answer to the urgency question was yes and it was associated with incontinence.
[4] Baseline measure from all subjects who were successfully implanted and completed the Fecal Incontinence Quality of Life (FIQOL) at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.
[5] Baseline measure from all subjects who were successfully implanted and completed the FIQOL at baseline, n=119. Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life.



  Outcome Measures
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1.  Primary:   Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week   [ Time Frame: Baseline and 12 months ]
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2.  Secondary:   Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week   [ Time Frame: Baseline and 12 months ]
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3.  Secondary:   Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle   [ Time Frame: Baseline and 12 months ]
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4.  Secondary:   Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior   [ Time Frame: Baseline and 12 Months ]
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5.  Secondary:   Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception   [ Time Frame: Baseline and 12 Months ]
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6.  Secondary:   Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment   [ Time Frame: Baseline and 12 Months ]
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7.  Secondary:   Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week   [ Time Frame: Baseline and 12 months ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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