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 ]

Measure Type	Primary
Measure Title	Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week
Measure Description	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.
Time Frame	Baseline and 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week [units: proportion of subjects] Mean ( 95% Confidence Interval )	0.73 ( 0.64 to 0.81 )

Statistical Analysis 1 for Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Episodes Per Week

Groups ^[1]	Implanted Subjects
Method ^[2]	Exact Binomial
P Value ^[3]	<0.0001
Proportion ^[4]	0.73
95% Confidence Interval	( 0.64 to 0.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

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

Measure Type	Secondary
Measure Title	Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week
Measure Description	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.
Time Frame	Baseline and 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. A modified worst-case analysis was used for missing data, where all subjects who were missing 12-month data were classified as failures unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week [units: proportion of subjects] Mean ( 95% Confidence Interval )	0.73 ( 0.64 to 0.81 )

Statistical Analysis 1 for Proportion of Subjects With at Least 50% Reduction in Number of Incontinent Days Per Week

Groups ^[1]	Implanted Subjects
Method ^[2]	Exact Binomial
P Value ^[3]	<0.0001
Proportion ^[4]	0.73
95% Confidence Interval	( 0.64 to 0.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle [ Time Frame: Baseline and 12 months ]

Measure Type	Secondary
Measure Title	Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle
Measure Description	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.
Time Frame	Baseline and 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle [units: units on a scale] Mean ± Standard Deviation	0.92 ± 0.92

Statistical Analysis 1 for Change in Quality of Life From Baseline to 12 Months: Scale 1 - Lifestyle

Groups ^[1]	Implanted Subjects
Method ^[2]	Wilcoxon signed-rank test
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.

4. Secondary:

Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior [ Time Frame: Baseline and 12 Months ]

Measure Type	Secondary
Measure Title	Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior
Measure Description	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.
Time Frame	Baseline and 12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior [units: units on a scale] Mean ± Standard Deviation	1.12 ± 0.99

Statistical Analysis 1 for Change in Quality of Life From Baseline to 12 Months: Scale 2 - Coping/Behavior

Groups ^[1]	Implanted Subjects
Method ^[2]	Wilcoxon signed-rank test
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.

5. Secondary:

Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception [ Time Frame: Baseline and 12 Months ]

Measure Type	Secondary
Measure Title	Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception
Measure Description	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.
Time Frame	Baseline and 12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception [units: units on a scale] Mean ± Standard Deviation	0.86 ± 0.96

Statistical Analysis 1 for Change in Quality of Life From Baseline to 12 Months: Scale 3 - Depression/Self-Perception

Groups ^[1]	Implanted Subjects
Method ^[2]	Wilcoxon signed-rank test
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.

6. Secondary:

Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment [ Time Frame: Baseline and 12 Months ]

Measure Type	Secondary
Measure Title	Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment
Measure Description	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.
Time Frame	Baseline and 12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in the analysis. The modified worst-case analysis was used to account for subjects who did not complete the FIQOL questionnaire at either baseline or 12 months; these subjects were classified as no change from baseline.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment [units: units on a scale] Mean ± Standard Deviation	1.06 ± 1.00

Statistical Analysis 1 for Change in Quality of Life From Baseline to 12 Months: Scale 4 - Embarrassment

Groups ^[1]	Implanted Subjects
Method ^[2]	Wilcoxon signed-rank test
P Value ^[3]	<0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.

7. Secondary:

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

Measure Type	Secondary
Measure Title	Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week
Measure Description	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.
Time Frame	Baseline and 12 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects who were successfully implanted were included in this analysis. The modified worst-case analysis for missing data was used, so that all subjects with missing 12-month data were classified as failures, unless there was a subsequent diary available, in which case the subsequent diary was substituted for the missing 12-month data.

Reporting Groups

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

Measured Values

	Implanted Subjects
Number of Participants Analyzed [units: participants]	120
Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week [units: proportion of subjects] Mean ( 95% Confidence Interval )	0.71 ( 0.62 to 0.79 )

Statistical Analysis 1 for Proportion of Subjects With at Least 50% Reduction in Number of Urgent Incontinent Episodes Per Week

Groups ^[1]	Implanted Subjects
Method ^[2]	Exact Binomial
P Value ^[3]	<0.0001
Proportion ^[4]	0.71
95% Confidence Interval	( 0.62 to 0.79 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chad Giese
Organization: Medtronic Neuromodulation
phone: 763-377-5955
e-mail: chad.giese@medtronic.com

Publications of Results:

Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9.

Wexner SD, Hull T, Edden Y, Coller JA, Devroede G, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. 2010 Jul;14(7):1081-9. Epub 2010 Mar 31.

Responsible Party:	Sudha Iyer, Clinical Research Manager, Medtronic
ClinicalTrials.gov Identifier:	NCT00200057 History of Changes
Other Study ID Numbers:	G010206
Study First Received:	September 12, 2005
Results First Received:	April 13, 2011
Last Updated:	January 17, 2013
Health Authority:	United States: Food and Drug Administration

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