Fecal Incontinence and ConstipationPhase 4MDT-301NCT00200005
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
A Phase 4 study testing Type: Implantable neurostimulator; InterStim in people with Fecal Incontinence and Constipation, run by MedtronicNeuro at 9 sites in 8 countries.
Trial summary
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Incontinence and Constipation
- What is being tested?
- Type: Implantable neurostimulator; InterStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesin 8 countries
- Study dates
- Nov 1998to Sep 2012
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
140 patients (7 study groups, up to 20 implanted patients per study group)
Fecal Incontinence groups:
Main Inclusion Criteria:
- Fecal incontinence (defined as incontinence to solid or liquid stool > 1 / week);
- Failed biofeedback or medical therapy;
Groups 1 - 5 patients with:
- Group 1) Circumferentially intact external anal sphincter, no previous surgery;
- Group 2) Circumferentially intact external anal sphincter after surgical repair;
- Group 3) Rectal prolapse repaired with a rectopexy;
- Group 4) Spinal injury including disc prolapse;
- Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis
Constipation groups:
Main Inclusion Criteria:
- Chronic constipation (defined as </= 2 weekly bowel movements; and/or >25% of bowel movements required straining; and/or >25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year
- Failed biofeedback or medical therapy;
Groups 6 - 7 patients with:
- Group 6) Idiopathic slow transit constipation as proven on colonic transit studies;
- Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.
Trial locations and contacts
9 sites in 8 countries.
9 sites in 8 countries
About this study
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
- Conditions
- Fecal Incontinence and Constipation
- Being tested
- Type: Implantable neurostimulator; InterStim
- Keywords
- Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation
- Medical subject headings
- Fecal Incontinence, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type: Implantable neurostimulator; InterStimDevice
Also called InterStim Model 3023, InterStim Model 3058
Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.
| Study group | Role | What they receive |
|---|---|---|
| InterStim therapy | Experimental | Patients being treated with sacral neuromodulation with InterStim therapy. Receives: Device: Type: Implantable neurostimulator; InterStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
Measured: Annually
Secondary outcomes (1)
FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.
Measured: Annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 1998
- Primary completionDec 2006
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Fecal Incontinence and ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Matzel, MD, Principal investigator, University Hospital Erlangen- Erlangen, GermanyMichael A Kamm, MD, Principal investigator, St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.Cor Baeten, MD, Principal investigator, Maastricht University Hospital- The NetherlandsJohn Christiansen, MD, Principal investigator, Herlev Hospital- Copenhagen, DenmarkAnders Mellgren, MD, Principal investigator, Danderyd Hospital- Stockholm, SwedenHarald Rosen, MD, Principal investigator, Danube Hospital/SMZ-Ost- Vienna, AustriaAlbert Navarro, MD, Principal investigator, Hospital Mutua de Terrassa- Terrassa, SpainRobert Madoff, MD, Principal investigator, University of Minnesota- Minneapolis, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200005
- Sponsor's protocol ID
- Mdt-301 November 03,1998
- Other IDs
- Mdt-301 (Nov 03, 98),, Amendment I (Dec 14, 99),, Amendment II (Jan 31, 02), Amendment III (Jul 01, 2009)
- Acronym
- MDT-301
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.
PubMed 7475602Matzel 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 15094271Jarrett ME, Matzel KE, Stosser M, Baeten CG, Kamm MA. Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum. 2005 Jun;48(6):1243-8. doi: 10.1007/s10350-004-0919-y.
PubMed 15793647Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stosser M, Madoff R, Kamm MA. Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg. 2005 Jun;92(6):734-9. doi: 10.1002/bjs.4859.
PubMed 15838899Jarrett ME, Matzel KE, Stosser M, Christiansen J, Rosen H, Kamm MA. Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Colorectal Dis. 2005 Sep;20(5):446-51. doi: 10.1007/s00384-004-0729-7. Epub 2005 Apr 21.
PubMed 15843939Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen H, Vaizey CJ, Matzel K, Baeten C. Sacral nerve stimulation for intractable constipation. Gut. 2010 Mar;59(3):333-40. doi: 10.1136/gut.2009.187989.
PubMed 20207638
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
- ClinicalTrials.gov ID
- NCT00200005
- Acronym / sponsor ID
- MDT-301 / Mdt-301 November 03,1998
- Conditions
- Fecal Incontinence and Constipation
- Keywords
- Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InterStim therapy | Experimental | Device: Type: Implantable neurostimulator; InterStimPatients being treated with sacral neuromodulation with InterStim therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type: Implantable neurostimulator; InterStimAlso: InterStim Model 3023, InterStim Model 3058Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant. | Device | InterStim therapy |
Primary outcome
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying
Time frame: Annually
1 secondary outcome
FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.
Time frame: Annually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Background: PubMed 7475602Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP. Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet. 1995 Oct 28;346(8983):1124-7. doi: 10.1016/s0140-6736(95)91799-3.
- Results publication: PubMed 15094271Matzel 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.
- Results publication: PubMed 15793647Jarrett ME, Matzel KE, Stosser M, Baeten CG, Kamm MA. Sacral nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum. 2005 Jun;48(6):1243-8. doi: 10.1007/s10350-004-0919-y.
- Results publication: PubMed 15838899Jarrett ME, Matzel KE, Christiansen J, Baeten CG, Rosen H, Bittorf B, Stosser M, Madoff R, Kamm MA. Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg. 2005 Jun;92(6):734-9. doi: 10.1002/bjs.4859.
- Results publication: PubMed 15843939Jarrett ME, Matzel KE, Stosser M, Christiansen J, Rosen H, Kamm MA. Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Colorectal Dis. 2005 Sep;20(5):446-51. doi: 10.1007/s00384-004-0729-7. Epub 2005 Apr 21.
- Results publication: PubMed 20207638Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, Johansson C, Laurberg S, Rosen H, Vaizey CJ, Matzel K, Baeten C. Sacral nerve stimulation for intractable constipation. Gut. 2010 Mar;59(3):333-40. doi: 10.1136/gut.2009.187989.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Matzel, MD principal investigator
University Hospital Erlangen- Erlangen, Germany
Michael A Kamm, MD principal investigator
St. Vincent's Hospital- Melbourne, Australia. Former: St. Mark's Hospital, London, U.K.
Cor Baeten, MD principal investigator
Maastricht University Hospital- The Netherlands
9 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Type: Implantable neurostimulator; InterStim in people with Fecal Incontinence and Constipation, run by MedtronicNeuro at 9 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, United States, Austria, Germany, Netherlands and 3 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptying (time frame: Annually). 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 NCT00200005, which also lists 6 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 10 Jan 2014.