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

Medtronic

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: Sacral Nerve Stimulation

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT01957969

1.05.8004

Details and patient eligibility

About

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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

234 participants in 2 patient groups

Principal Population

Description:

Patients who undergo a definitive neuro-stimulator implantation.

Treatment:

Device: Sacral Nerve Stimulation

Annex Population

Description:

Patients who do not respond to the temporary test for the neurostimulator implantation

Treatment:

Device: Sacral Nerve Stimulation