Fecal Incontinence
Conditions
Brief summary
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.
Interventions
DEVICESacral Nerve Stimulation
Sponsors
Medtronic France SAS
Medtronic MCRI
MedtronicNeuro
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline. | 6 months (4-8 months) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Reduction of incontinence episodes per week | 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) |
| Complications and Adverse Events | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) |
Countries
France
Outcome results
None listed