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Completed

NCT Number: NCT01957969

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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Estaing, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sacral nerve stimulation

Device

Other names: INTERSTIM

Primary outcomes

  1. Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline.

    Time frame: 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 outcomes

  1. Reduction of incontinence episodes per week

    Time frame: 12 months (9-15 months)

  2. Reduction of evacuations per week

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

  3. Reduction of urgency episodes per week

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

  4. Retention delay

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

  5. Complications and Adverse Events

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

  6. Fecal Incontinence severity

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

  7. Quality of Life

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

  8. Patient Satisfaction

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

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Collaborators

  • Medtronic France SAS
  • Medtronic MCRI

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2013
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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