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

Completed

• Conditions: Fecal Incontinence

• Registration Number: NCT01957969
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-04
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-08
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reduction of evacuations per week	6 months (4-8 months) and 12 months (9-15 months)
Patient Satisfaction	6 months (5-8 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)
Complications and Adverse Events	3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Fecal Incontinence severity	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)
Quality of Life	3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

Trial Locations

Locations (16)

CHU Estaing; 🇫🇷 Clermont Ferrand, France

CHU Grenoble - Hôpital Michallon; 🇫🇷 Grenoble, France

CHRU Lille - Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU Dupuytren; 🇫🇷 Limoges, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

APM Hopital Nord; 🇫🇷 Marseille, France

CHU Nantes - Hotel Dieu; 🇫🇷 Nantes, France

GH Diaconesses Croix St Simon; 🇫🇷 Paris, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

CHU La Milétrie; 🇫🇷 Poitiers, France

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