Clinical trial NCT01957969: French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
Official title: French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
Collaborators: name: Medtronic France SAS
name: Medtronic MCRI
First posted: 2013-10-08
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French subjects affected by fecal incontinence, indicated to sacral neuromodulation therapy.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline.
timeFrame: 6 months (4-8 months)
Secondary outcomes:
measure: Reduction of incontinence episodes per week
timeFrame: 12 months (9-15 months)
measure: Reduction of evacuations per week
timeFrame: 6 months (4-8 months) and 12 months (9-15 months)
measure: Reduction of urgency episodes per week
timeFrame: 6 months (4-8 months) and 12 months (9-15 months)
measure: Retention delay
timeFrame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
measure: Complications and Adverse Events
timeFrame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
measure: Fecal Incontinence severity
timeFrame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
measure: Quality of Life
timeFrame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
measure: Patient Satisfaction
timeFrame: 6 months (5-8 months) and 12 months (9-15 months)
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: CHU Estaing
city: Grenoble
country: France
facility: CHU Grenoble - Hôpital Michallon
city: Lille
country: France
facility: CHRU Lille - Hôpital Claude Huriez
city: Limoges
country: France
facility: CHU Dupuytren
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: APM Hopital Nord
city: Nantes
country: France
facility: CHU Nantes - Hotel Dieu
city: Paris
country: France
facility: GH Diaconesses Croix St Simon
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Poitiers
country: France
facility: CHU La Milétrie
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Charles Nicolle
city: St Jean de Luz
country: France
facility: Polyclinique Pays Basque Sud
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulouse
country: France
facility: CHU Toulouse - Hotel Dieu PURPAN
city: Toulouse
country: France
facility: Clinique St Jean du Languedoc
Study officials:
References:
citation: 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.
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. doi: 10.1002/bjs.4545.
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. doi: 10.1007/s10350-004-0589-9.
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.
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.
citation: 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.
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.
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.
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. doi: 10.1097/01.sla.0000186281.09475.db.
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.
citation: 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.
citation: 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.