Faecal IncontinenceNCT05049486
Computational Model of SNS (Sacral Nerve Stimulation) Induced Electrical Current Flow Using Tractography Imaging
A study testing CT scan in people with Faecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 26 Mar 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent
- Patients with symptoms of faecal incontinence for solid or liquid stool
- Patients who have had successful outcome from temporary SNS
- Patients who are willing and competent to fill in questionnaires and undergo an extra CT and MRI scan during the study
Who cannot join
- Patients who are claustrophobic to undertake MRI scan
- Patients who had previous devices implanted that may be magnetically, electrically, mechanically activated or affected by MRI scan
- Pregnant patients
- Patients who are breastfeeding
- Patients who are psychologically unstable and unsuitable for intervention and unable to provide informed consent
- Patients who did not successfully pass the trial of SNS temporary SNS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computational Model of SNS Using Tractography
This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). DTI is a non-invasive technique sometimes described as fiber tractography that enables visualization of the pathways and integrity of nerves. In this feasibility study, we plan to use DTI to assess the sacral plexus and its peripheral nerves. A model will be constructed by superimposing SNS lead from a CT scan onto the DTI imaging to map out the electrode position. It is hoped that this study will lead to a better understanding of both therapeutic and adverse stimulation effects and enable patient-specific adjustments of stimulation parameters.
Read the detailed description
Patients who have had successful temporary SNS and awaiting permanent SNS will be approached. An assessment will be made to determine whether the patient meets the inclusion/exclusion criteria. Patients will be given a consent form to sign.
The investigators will recruit from the outpatient clinic a total of ten patients for this study.
A physical examination will be performed as per standard practice. Patients will be asked to fill in questionnaires probing the severity of faecal incontinence symptoms. Included questionnaires are ICIQ-B4, Wexner's and St Mark's.
Incontinence score (see appendix). It will also evaluate any existing pain symptoms.
The patient will undergo an MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed at Mount Vernon Hospital over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing.
A surgical procedure (implant of SNS) will be performed as per standard practice.
Briefly, an antibiotic will be given at induction of anesthesia prior to skin incision. All types of equipment for SNS implantation will be soaked in antibiotic solution (gentamicin 80mg in 500ml of normal saline or equivalent). Under general anesthesia without neuromuscular junction blockade and the patient in prone position, a permanent quadripolar lead (model 3889) will be inserted aiming to observe contraction of the anus and/or toe flexion, which are signs to confirm that the lead is nearby third sacral nerve root. The lead position will be confirmed by an x-ray and the lead will be connected to an implantable neurostimulator which will be placed under the skin but deep enough in the upper outer area of the buttock region. The procedure will be performed according to the manufacturer's manual as per our clinical standard.
After the implantation, patients will be given one generic starting program to start the therapy.
Three to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed (see details below).
After the scan, a clinician will test stimulation settings systematically to find an optimal program. Briefly, as the lead as 4 electrodes, each electrode will be tested, followed by a combination of electrodes. The patient's subjective responses (type and site of sensation, if there is any pain/discomfort site and nature, a degree of pain using a Lickert scale,) will be recorded. The investigators will try and obtain motor response if possible, at the level when patients' anus contracts slightly if this is achievable without causing significant distress and pain to the patients. This is also a routine process and the clinician will note if there is any specific setting that causes adverse pain and identify settings that are comfortable and give stimulation sensation around the anus.
The computational model will be done in a computer laboratory and the record will be compared and evaluated for any clinical relevance. The same set of questionnaires used during the baseline evaluation will be repeated at follow-ups, as per routine care.
- Conditions
- Faecal Incontinence
- Being tested
- CT scan
- Keywords
- Sacral Nerve Stimulator;, DTI;, MRI;, Faecal Incontinence;, CT scan;
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
Patients will undergone a pelvic CT scan.
| Study group | Role | What they receive |
|---|---|---|
| MRI sequences and (DTI) | No intervention | The aim of this study is to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high resolution anatomical MRI sequences and diffusion tensor imaging (DTI). To do so, the patient will undergo a MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing. |
| CT scan | Active comparator | Three to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed. Receives: Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead.
Size and distance of the sacral nerves from the implanted lead measured in millimetres (mm).
Measured: 12 months
Secondary outcomes (1)
Stimulation of the sacral nerve using computational model induced electrical current to establish therapeutic range of SNS
Patient's sensation of stimulation will be measured in amplitude (reported in voltage) shown in the standard remote control during the patient stimulation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start1 Oct 2017
- Primary completion1 Dec 2017
- Study completion26 Mar 2018
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 Faecal IncontinenceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Carolynne Vaizey, FRCS, Principal investigator, London North West NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049486
- Sponsor's protocol ID
- London North West NHS Trust
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD. Reserach results will be shared at the end of the study by local conferences and by peer scientific journals.
Publications
Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
PubMed 8416784Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
PubMed 9862829Maeda Y, Lundby L, Buntzen S, Laurberg S. Outcome of sacral nerve stimulation for fecal incontinence at 5 years. Ann Surg. 2014 Jun;259(6):1126-31. doi: 10.1097/SLA.0b013e31829d3969.
PubMed 23817505Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011 Jan;98(1):140-7. doi: 10.1002/bjs.7302. Epub 2010 Oct 27.
PubMed 21136568van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.
PubMed 22705377Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL. A patient-centered approach to developing a comprehensive symptom and quality of life assessment of anal incontinence. Dis Colon Rectum. 2008 Jan;51(1):82-7. doi: 10.1007/s10350-007-9069-3. Epub 2007 Nov 15.
PubMed 18008106
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Model of SNS Using Tractography
- ClinicalTrials.gov ID
- NCT05049486
- Acronym / sponsor ID
- London North West NHS Trust
- Conditions
- Faecal Incontinence
- Keywords
- Sacral Nerve Stimulator;, DTI;, MRI;, Faecal Incontinence;, CT scan;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 20 Sep 2021 (actual)
- 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.
This study aims to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high-resolution anatomical MRI sequences and diffusion tensor imaging (DTI). DTI is a non-invasive technique sometimes described as fiber tractography that enables visualization of the pathways and integrity of nerves. In this feasibility study, we plan to use DTI to assess the sacral plexus and its peripheral nerves. A model will be constructed by superimposing SNS lead from a CT scan onto the DTI imaging to map out the electrode position. It is hoped that this study will lead to a better understanding of both therapeutic and adverse stimulation effects and enable patient-specific adjustments of stimulation parameters.
Detailed description
Patients who have had successful temporary SNS and awaiting permanent SNS will be approached. An assessment will be made to determine whether the patient meets the inclusion/exclusion criteria. Patients will be given a consent form to sign.
The investigators will recruit from the outpatient clinic a total of ten patients for this study.
A physical examination will be performed as per standard practice. Patients will be asked to fill in questionnaires probing the severity of faecal incontinence symptoms. Included questionnaires are ICIQ-B4, Wexner's and St Mark's.
Incontinence score (see appendix). It will also evaluate any existing pain symptoms.
The patient will undergo an MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed at Mount Vernon Hospital over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing.
A surgical procedure (implant of SNS) will be performed as per standard practice.
Briefly, an antibiotic will be given at induction of anesthesia prior to skin incision. All types of equipment for SNS implantation will be soaked in antibiotic solution (gentamicin 80mg in 500ml of normal saline or equivalent). Under general anesthesia without neuromuscular junction blockade and the patient in prone position, a permanent quadripolar lead (model 3889) will be inserted aiming to observe contraction of the anus and/or toe flexion, which are signs to confirm that the lead is nearby third sacral nerve root. The lead position will be confirmed by an x-ray and the lead will be connected to an implantable neurostimulator which will be placed under the skin but deep enough in the upper outer area of the buttock region. The procedure will be performed according to the manufacturer's manual as per our clinical standard.
After the implantation, patients will be given one generic starting program to start the therapy.
Three to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed (see details below).
After the scan, a clinician will test stimulation settings systematically to find an optimal program. Briefly, as the lead as 4 electrodes, each electrode will be tested, followed by a combination of electrodes. The patient's subjective responses (type and site of sensation, if there is any pain/discomfort site and nature, a degree of pain using a Lickert scale,) will be recorded. The investigators will try and obtain motor response if possible, at the level when patients' anus contracts slightly if this is achievable without causing significant distress and pain to the patients. This is also a routine process and the clinician will note if there is any specific setting that causes adverse pain and identify settings that are comfortable and give stimulation sensation around the anus.
The computational model will be done in a computer laboratory and the record will be compared and evaluated for any clinical relevance. The same set of questionnaires used during the baseline evaluation will be repeated at follow-ups, as per routine care.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI sequences and (DTI) | No intervention | –The aim of this study is to obtain finer details of tissues surrounding a lead in the pelvis using a combination of high resolution anatomical MRI sequences and diffusion tensor imaging (DTI). To do so, the patient will undergo a MRI scan (3 Tesla) of the pelvis using sequences including anatomical sequences and diffusion tensor imaging technique for construction of sacral nerve tractography prior to permanent SNS. This will be performed over an hour: first 30 minutes for anatomical sequences and the second 30 minutes for DTI sequencing. |
| CT scan | Active comparator | Radiation: CT scanThree to 4 weeks after the procedure the patient will undergo a limited CT scan of the pelvis to visualise the position of the SNS lead. The scan will focus only on the sacrum, implanted lead, and rectum and will not be extended beyond this area. Imaging from this CT will be superimposed to the MRI imaging the patient had pre-operatively, and a computational simulation will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are psychologically stable and suitable for intervention and able to provide informed consent
- Patients with symptoms of faecal incontinence for solid or liquid stool
- Patients who have had successful outcome from temporary SNS
- Patients who are willing and competent to fill in questionnaires and undergo an extra CT and MRI scan during the study
Key exclusion criteria (6 listed)
- Patients who are claustrophobic to undertake MRI scan
- Patients who had previous devices implanted that may be magnetically, electrically, mechanically activated or affected by MRI scan
- Pregnant patients
- Patients who are breastfeeding
- Patients who are psychologically unstable and unsuitable for intervention and unable to provide informed consent
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 |
|---|---|---|
| CT scanPatients will undergone a pelvic CT scan. | Radiation | CT scan |
Primary outcome
Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead.
Time frame: 12 months
Size and distance of the sacral nerves from the implanted lead measured in millimetres (mm).
1 secondary outcome
Stimulation of the sacral nerve using computational model induced electrical current to establish therapeutic range of SNS
Time frame: 12 months
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 20 Sep 2021.
- Background: PubMed 8416784Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
- Background: PubMed 9862829Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999 Jan;44(1):77-80. doi: 10.1136/gut.44.1.77.
- Results publication: PubMed 23817505Maeda Y, Lundby L, Buntzen S, Laurberg S. Outcome of sacral nerve stimulation for fecal incontinence at 5 years. Ann Surg. 2014 Jun;259(6):1126-31. doi: 10.1097/SLA.0b013e31829d3969.
- Results publication: PubMed 21136568Maeda Y, Lundby L, Buntzen S, Laurberg S. Suboptimal outcome following sacral nerve stimulation for faecal incontinence. Br J Surg. 2011 Jan;98(1):140-7. doi: 10.1002/bjs.7302. Epub 2010 Oct 27.
- Results publication: PubMed 22705377van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.
- Results publication: PubMed 18008106Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL. A patient-centered approach to developing a comprehensive symptom and quality of life assessment of anal incontinence. Dis Colon Rectum. 2008 Jan;51(1):82-7. doi: 10.1007/s10350-007-9069-3. Epub 2007 Nov 15.
- Individual participant dataSharing planned: No. There is no plan to make IPD. Reserach results will be shared at the end of the study by local conferences and by peer scientific journals.
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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.
Carolynne Vaizey, FRCS principal investigator
London North West NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Faecal Incontinence, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
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 6 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Implanting a lead around a nerve for finer details of tissues surrounding a sacral nerve stimulation lead. (time frame: 12 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 NCT05049486, 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 20 Sep 2021.