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

NCT01957969 | Completed

• 1 other identifier: 1.05.8004
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 16

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• 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

  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)

Study Arms (2)

Principal Population

Patients who undergo a definitive neuro-stimulator implantation.

Device: Sacral Nerve Stimulation

Annex Population

Patients who do not respond to the temporary test for the neurostimulator implantation

Device: Sacral Nerve Stimulation

Interventions

Sacral Nerve Stimulation DEVICE

Also known as: INTERSTIM

Annex Population; Principal Population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

French subjects affected by fecal incontinence, indicated to sacral neuromodulation therapy.

You may qualify if:

• 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.

You may not qualify if:

• Patient unwilling to comply to data collection and publication rules.

Sponsors & Collaborators

• MedtronicNeuro: lead
• Medtronic France SAS: collaborator
• Medtronic MCRI: collaborator

Study Sites (16)

CHU Estaing

Clermont-Ferrand, France

Location

CHU Grenoble - Hôpital Michallon

Grenoble, France

Location

CHRU Lille - Hôpital Claude Huriez

Lille, France

Location

CHU Dupuytren

Limoges, France

Location

Hopital Edouard Herriot

Lyon, France

Location

APM Hopital Nord

Marseille, France

Location

CHU Nantes - Hotel Dieu

Nantes, France

Location

GH Diaconesses Croix St Simon

Paris, France

Location

Hôpital Saint Joseph

Paris, France

Location

CHU La Milétrie

Poitiers, 86021, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, France

Location

CHU Charles Nicolle

Rouen, France

Location

Polyclinique Pays Basque Sud

Saint-Jean-de-Luz, France

Location

CHU Hautepierre

Strasbourg, France

Location

CHU Toulouse - Hotel Dieu PURPAN

Toulouse, France

Location

Clinique St Jean du Languedoc

Toulouse, France

Location

Related Publications (12)

• 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.

  PMID: 15094271 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.

  PMID: 15164447 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.

  PMID: 15484349 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.

  PMID: 19863601 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.

  PMID: 21825885 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.

  PMID: 19273950 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.

  PMID: 20160636 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.

  PMID: 18278532 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.

  PMID: 16244539 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.

  PMID: 21279370 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.

  PMID: 18727721 BACKGROUND

• 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.

  PMID: 33387373 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

FR (16)