French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

Study Overview
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Brief Summary
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The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence. This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.

Official Title
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French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Sacral Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient willing to sign the Data Release Form stating the non opposition to the study conduct; Patient able to understand information given by the investigator in terms of data collection and publication; At least 18 years old or older. Patient indicated to sacral neuromodulation testing with InterStim® system. Exclusion Criteria: Replacement of an existing sacral neuromodulation system (implanted before inclusion period) without any evidence of benefits during a testing period. Patient unwilling to comply to data collection and publication rules.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Principal Population<br>Patients who undergo a definitive neuro-stimulator implantation. | Device: Sacral Nerve Stimulation<br> <br> * Other names: INTERSTIM;|
| Annex Population<br>Patients who do not respond to the temporary test for the neurostimulator implantation | Device: Sacral Nerve Stimulation<br> <br> * Other names: INTERSTIM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline. | The primary objective will evaluate the proportion of implanted patients that do not experience any serious adverse event or serious adverse device effect at 4-8 months of follow-up and show a reduction of at least 50% of incontinence episodes per week at the same timeframe, compared to baseline. | 6 months (4-8 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of incontinence episodes per week |  | 12 months (9-15 months) | 
| Reduction of evacuations per week |  | 6 months (4-8 months) and 12 months (9-15 months) | 
| Reduction of urgency episodes per week |  | 6 months (4-8 months) and 12 months (9-15 months) | 
| Retention delay |  | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) | 
| Complications and Adverse Events |  | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) | 
| Fecal Incontinence severity |  | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) | 
| Quality of Life |  | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) | 
| Patient Satisfaction |  | 6 months (5-8 months) and 12 months (9-15 months) |