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

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

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

Interventions

  • Device: Sacral Nerve Stimulation

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • MedtronicNeuro
  • Collaborator
    • Medtronic France SAS
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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