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

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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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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