French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
- Conditions
- Fecal Incontinence
- Interventions
- Device: Sacral Nerve Stimulation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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.
- 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
- Arm && Interventions
Group Intervention Description Annex Population Sacral Nerve Stimulation Patients who do not respond to the temporary test for the neurostimulator implantation Principal Population Sacral Nerve Stimulation Patients who undergo a definitive neuro-stimulator implantation.
- 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 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) 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)
Trial Locations
- Locations (16)
CHU Nantes - Hotel Dieu
🇫🇷Nantes, France
CHU Grenoble - Hôpital Michallon
🇫🇷Grenoble, France
CHU Dupuytren
🇫🇷Limoges, France
APM Hopital Nord
🇫🇷Marseille, France
CHU La Milétrie
🇫🇷Poitiers, France
Polyclinique Pays Basque Sud
🇫🇷St Jean de Luz, France
GH Diaconesses Croix St Simon
🇫🇷Paris, France
CHU Rennes - Hôpital Pontchaillou
🇫🇷Rennes, France
Clinique St Jean du Languedoc
🇫🇷Toulouse, France
CHU Hautepierre
🇫🇷Strasbourg, France
CHU Toulouse - Hotel Dieu PURPAN
🇫🇷Toulouse, France
CHU Charles Nicolle
🇫🇷Rouen, France
CHU Estaing
🇫🇷Clermont Ferrand, France
Hopital Edouard Herriot
🇫🇷Lyon, France
Hôpital Saint Joseph
🇫🇷Paris, France
CHRU Lille - Hôpital Claude Huriez
🇫🇷Lille, France