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Fecal IncontinenceNCT01957969

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

An observational study of Fecal Incontinence, run by MedtronicNeuro at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fecal Incontinence
What is being tested?
Sacral Nerve Stimulation
Type of treatment
Medical device
How many people
234 participants
Where
16 sitesFrance
Study dates
Sep 2013to Dec 2017
How long will I take part?
15 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites

  • CHU Estaing

    Clermont-Ferrand

  • CHU Grenoble - Hôpital Michallon

    Grenoble

  • CHRU Lille - Hôpital Claude Huriez

    Lille

  • CHU Dupuytren

    Limoges

  • Hopital Edouard Herriot

    Lyon

  • APM Hopital Nord

    Marseille

  • CHU Nantes - Hotel Dieu

    Nantes

  • GH Diaconesses Croix St Simon

    Paris

  • Hôpital Saint Joseph

    Paris

  • CHU La Milétrie

    Poitiers, 86021

  • CHU Rennes - Hôpital Pontchaillou

    Rennes

  • CHU Charles Nicolle

    Rouen

  • Polyclinique Pays Basque Sud

    Saint-Jean-de-Luz

  • CHU Hautepierre

    Strasbourg

  • CHU Toulouse - Hotel Dieu PURPAN

    Toulouse

  • Clinique St Jean du Languedoc

    Toulouse

Other trials in France

About this study

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.

Being tested
Sacral Nerve Stimulation
Medical subject headings
Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral Nerve StimulationDevice

    Also called INTERSTIM

Study groups in NCT01957969
Study groupRoleWhat they receive
Principal PopulationPatients who undergo a definitive neuro-stimulator implantation.
Receives: Device: Sacral Nerve Stimulation
Annex PopulationPatients who do not respond to the temporary test for the neurostimulator implantation
Receives: Device: Sacral Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months (4-8 months)

Secondary outcomes (8)

  1. Reduction of incontinence episodes per week

    Measured: 12 months (9-15 months)

  2. Reduction of evacuations per week

    Measured: 6 months (4-8 months) and 12 months (9-15 months)

  3. Reduction of urgency episodes per week

    Measured: 6 months (4-8 months) and 12 months (9-15 months)

  4. Retention delay

    Measured: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

  5. Complications and Adverse Events

    Measured: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

  6. Fecal Incontinence severity

    Measured: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

  7. Quality of Life

    Measured: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)

  8. Patient Satisfaction

    Measured: 6 months (5-8 months) and 12 months (9-15 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
234 participants (actual)
Target duration
15 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01957969
Sponsor's protocol ID
1.05.8004
Status last verified
Jan 2018
First submitted
4 Oct 2013
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15094271

  • 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.

    PubMed 15164447

  • 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.

    PubMed 15484349

  • 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.

    PubMed 19863601

  • 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.

    PubMed 21825885

  • 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.

    PubMed 19273950

  • 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.

    PubMed 20160636

  • 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.

    PubMed 18278532

  • 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.

    PubMed 16244539

  • 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.

    PubMed 21279370

  • 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.

    PubMed 18727721

  • 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.

    PubMed 33387373

Questions about this trial

What is this clinical trial studying?

An observational study of Fecal Incontinence, run by MedtronicNeuro at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01957969, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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