French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence
NCT ID: NCT01957969
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
234 participants
OBSERVATIONAL
2013-09-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
NCT02186041
Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
NCT00977652
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
NCT00200005
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
NCT00200057
Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence
NCT00974909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Principal Population
Patients who undergo a definitive neuro-stimulator implantation.
Sacral Nerve Stimulation
Annex Population
Patients who do not respond to the temporary test for the neurostimulator implantation
Sacral Nerve Stimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sacral Nerve Stimulation
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patient unwilling to comply to data collection and publication rules.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic France SAS
INDUSTRY
Medtronic MCRI
UNKNOWN
MedtronicNeuro
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Saint-Jean-de-Luz, , France
CHU Hautepierre
Strasbourg, , France
CHU Toulouse - Hotel Dieu PURPAN
Toulouse, , France
Clinique St Jean du Languedoc
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1.05.8004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.