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

N/ACompletedNCT01957969

MedtronicNeuro234 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

234

Conditions

Fecal Incontinence

Interventions

Sacral Nerve StimulationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

CHU Estaing

Clermont-Ferrand, France

CHU Grenoble - Hôpital Michallon

Grenoble, France

CHRU Lille - Hôpital Claude Huriez

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 6 months (4-8 months)

Secondary Outcomes

Reduction of incontinence episodes per week

Time frame: 12 months (9-15 months)

Reduction of evacuations per week

Time frame: 6 months (4-8 months) and 12 months (9-15 months)

Reduction of urgency episodes per week

Time frame: 6 months (4-8 months) and 12 months (9-15 months)

Retention delay

Time frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

Complications and Adverse Events

Time frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

Fecal Incontinence severity

Time frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

Quality of Life

Time frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

Patient Satisfaction

Time frame: 6 months (5-8 months) and 12 months (9-15 months)

Data from ClinicalTrials.gov

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