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| Name | Class |
|---|---|
| Medtronic France SAS | INDUSTRY |
| Medtronic MCRI | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Principal Population | Patients who undergo a definitive neuro-stimulator implantation. |
| |
| Annex Population | Patients who do not respond to the temporary test for the neurostimulator implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacral Nerve Stimulation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months (4-8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of incontinence episodes per week | 12 months (9-15 months) | |
| Reduction of evacuations per week | 6 months (4-8 months) and 12 months (9-15 months) | |
| Reduction of urgency episodes per week |
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Inclusion Criteria:
Exclusion Criteria:
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French subjects affected by fecal incontinence, indicated to sacral neuromodulation therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Clermont-Ferrand | France | ||||
| CHU Grenoble - Hôpital Michallon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15094271 | Background | Matzel KE, Kamm MA, Stosser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6. doi: 10.1016/S0140-6736(04)15999-0. | |
| 15164447 | Background | Jarrett ME, Varma JS, Duthie GS, Nicholls RJ, Kamm MA. Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg. 2004 Jun;91(6):755-61. doi: 10.1002/bjs.4545. |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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) |
| Quality of Life | 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) |
| Patient Satisfaction | 6 months (5-8 months) and 12 months (9-15 months) |
| 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 | 86021 | France |
| CHU Rennes - Hôpital Pontchaillou | Rennes | France |
| CHU Charles Nicolle | Rouen | France |
| Polyclinique Pays Basque Sud | Saint-Jean-de-Luz | France |
| CHU Hautepierre | Strasbourg | France |
| CHU Toulouse - Hotel Dieu PURPAN | Toulouse | France |
| Clinique St Jean du Languedoc | Toulouse | France |
| 15484349 | Background | Uludag O, Koch SM, van Gemert WG, Dejong CH, Baeten CG. Sacral neuromodulation in patients with fecal incontinence: a single-center study. Dis Colon Rectum. 2004 Aug;47(8):1350-7. doi: 10.1007/s10350-004-0589-9. |
| 19863601 | Background | Altomare DF, Rinaldi M, Lobascio P, Marino F, Giuliani RT, Cuccia F. Factors affecting the outcome of temporary sacral nerve stimulation for faecal incontinence. The value of the new tined lead electrode. Colorectal Dis. 2011 Feb;13(2):198-202. doi: 10.1111/j.1463-1318.2009.02088.x. |
| 21825885 | Background | Mellgren A, Wexner SD, Coller JA, Devroede G, Lerew DR, Madoff RD, Hull T; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011 Sep;54(9):1065-75. doi: 10.1097/DCR.0b013e31822155e9. |
| 19273950 | Background | Altomare DF, Ratto C, Ganio E, Lolli P, Masin A, Villani RD. Long-term outcome of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2009 Jan;52(1):11-7. doi: 10.1007/DCR.0b013e3181974444. |
| 20160636 | Background | Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0. |
| 18278532 | Background | Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008 May;51(5):494-502. doi: 10.1007/s10350-007-9103-5. Epub 2008 Feb 16. |
| 16244539 | Background | Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, Bresler L, Portier G, Michot F; Study Group. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005 Nov;242(5):662-9. doi: 10.1097/01.sla.0000186281.09475.db. |
| 21279370 | Background | Tan E, Ngo NT, Darzi A, Shenouda M, Tekkis PP. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis. 2011 Mar;26(3):275-94. doi: 10.1007/s00384-010-1119-y. Epub 2011 Jan 29. |
| 18727721 | Background | Matzel KE, Lux P, Heuer S, Besendorfer M, Zhang W. Sacral nerve stimulation for faecal incontinence: long-term outcome. Colorectal Dis. 2009 Jul;11(6):636-41. doi: 10.1111/j.1463-1318.2008.01673.x. Epub 2008 Aug 21. |
| 33387373 | Derived | Meurette G, Siproudhis L, Leroi AM, Damon H, Urs Josef Keller D, Faucheron JL; French Faecal Registry Study Group. Sacral neuromodulation with the InterStim system for faecal incontinence: results from a prospective French multicentre observational study. Colorectal Dis. 2021 Jun;23(6):1463-1473. doi: 10.1111/codi.15507. Epub 2021 Mar 12. |