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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957969
• Other study ID #: 1.05.8004
• Status: Completed
• Phase: N/A
• First received: October 4, 2013
• Last updated: January 18, 2018
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Sacral Nerve Stimulation

Locations

Country	Name	City	State
France	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	CHU Rennes - Hôpital Pontchaillou	Rennes
France	CHU Charles Nicolle	Rouen
France	Polyclinique Pays Basque Sud	St Jean de Luz
France	CHU Hautepierre	Strasbourg
France	CHU Toulouse - Hotel Dieu PURPAN	Toulouse
France	Clinique St Jean du Languedoc	Toulouse

Sponsors (3)

Lead Sponsor	Collaborator
MedtronicNeuro	Medtronic France SAS, Medtronic MCRI

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Matzel KE, Kamm MA, Stösser 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. — View Citation

Matzel KE, Lux P, Heuer S, Besendörfer 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction of incontinence episodes per week		12 months (9-15 months)
Secondary	Reduction of evacuations per week		6 months (4-8 months) and 12 months (9-15 months)
Secondary	Reduction of urgency episodes per week		6 months (4-8 months) and 12 months (9-15 months)
Secondary	Retention delay		3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Secondary	Complications and Adverse Events		3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Secondary	Fecal Incontinence severity		3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Secondary	Quality of Life		3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Secondary	Patient Satisfaction		6 months (5-8 months) and 12 months (9-15 months)