Faecal IncontinenceSNSNCT03261622
Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective
A study testing Sacral nerve stimulation at different stimulation amplitudes in people with Faecal Incontinence and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
Trial summary
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). In a selected patient group we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence, Fecal Incontinence
- What is being tested?
- Sacral nerve stimulation at different stimulation amplitudes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2016to 1 Nov 2020
- 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
- ≥18 years
- Informed consent
- Idiopathic faecal incontinence or incontinence following external sphincter tear ≤ 160 degrees.
- ≥ one faecal incontinence episode after optimized conservative treatment.
- Ability to use the patient programmer.
Who cannot join
- Pregnancy
- Diabetes
- Neurological diseases, including spinal cord injuries
- Pelvic irradiation
- Rectal resections
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, 8000
About this study
Official title: Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI).
In a selected patient group we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.
Read more
Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.
During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2 pattern. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.
Read the detailed description
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). The therapy is recommended by the International Continence Society (ICS) if conservative treatments such as; regulation of diet and fibre supplements, medication, biofeedback therapy, glycerol suppositories, mini enema or transanal irrigation have been insufficient to improve continence to a satisfactory level.
The SNS therapy has traditionally been applied as a two step procedure. Firstly, a 3-4 week test-period, often with a permanent electrode with tines, followed by permanent implantation if at least a 50% symptom reduction has been obtained during the test stimulation.
In a selected patient group(idiopathic faecal incontinence or incontinence as a result of an external anal sphincter tear (<160 degrees)) we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP(unpublished data, submitted for publication) .
Thus, only 10% of the patients have the lead explanted after 3 to 4 weeks. In 90% of the patients a pacemaker is implanted after the test period, these patients will have an additional operation that could have been avoided if they had the permanent pacemaker implanted at the first stage.
Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.
During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.
- Conditions
- Faecal Incontinence, Fecal Incontinence
- Being tested
- Sacral nerve stimulation at different stimulation amplitudes
- Keywords
- Sacral Nerve Stimulation, Sacral Nerve Modulation
- Medical subject headings
- Encopresis, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral nerve stimulation at different stimulation amplitudesDevice
Exploring the effect of different stimulation amplitude in a randomized study
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Active comparator | Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks) Receives: Device: Sacral nerve stimulation at different stimulation amplitudes |
| Intervention arm | Sham comparator | Alternation of stimulation amplitude
1. Period - Stimulation amplitude 0.05 Volts (lowest possible)
2. Period - Stimulation amplitude - 50% of sensory threshold.
3. Period - Stimulation amplitude - 90% of sensory threshold. Receives: Device: Sacral nerve stimulation at different stimulation amplitudes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Habit Diary changes
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Measured: 12 weeks
Bowel Habit Diary changes
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Measured: 4 weeks
Secondary outcomes (7)
Bowel Habit Diary
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Measured: 24 weeks
Functional outcome measure - Wexner Incontinence score
Changes in Wexner incontinence score, compared to baseline.
Measured: 4, 8, 12, and 24 weeks
Functional outcome measure - St. Marks incontinence score
Changes in St. Marks incontinence score, compared to baseline.
Measured: 4, 8, 12, and 24 weeks
Quality of Life FI - specific
Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline
Measured: 4, 8, 12, and 24 weeks
Changes in functional outcome - Urin incontinence (UI).
ICIQ_UI Short form,
Measured: 4, 8, 12, and 24 weeks
Visual analogue score (VAS score): patients overall satisfaction
VAS-score (0-100) for patients satisfaction with overall:
- Social function
- Bowel function
- Quality of life Baseline value used as reference
Measured: 4, 8, 12, and 24 weeks
Anal physiology test
Functional Lumen Imaging Probe (endoFLIP) and anal sensibility. The endoFLIP allows dynamic examination of the geometry and segmental distensibility properties of the anal canal by simultaneous measurement of anal pressure(PSI) and luminal cross sectional areas (CSAs) at 16 points along the length of the anal canal
Measured: baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Nov 2016
- Primary completion1 Nov 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either control group (Stimulation amplitude at 90% of sensory threshold) or intervention arm (different stimulation amplitude - 0.05 V, 50 and 90% of sensory threshold)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, Hvidovre University Hospital
- Responsible party
- Principal investigator, Jakob Jakobsen, University of Aarhus
- Investigators
- Jakob K. Jakobsen, MD. Ph.D., Principal investigator, Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261622
- Sponsor's protocol ID
- 005
- Acronym
- SNS
- Status last verified
- Oct 2023
- First submitted
- 23 Jun 2017
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participants in the study group have access to the data and if agreed in the study group sub-analysis can be made after the trial has ended.
Publications
Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S, Sorensen M, Rydningen M. Sacral neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence - results from a randomised study with a one-stage implant procedure. Tech Coloproctol. 2025 Dec 24;30(1):18. doi: 10.1007/s10151-025-03254-9.
PubMed 41444840Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S, Sorensen M, Rydningen M. One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study. Colorectal Dis. 2024 May;26(5):968-973. doi: 10.1111/codi.16936. Epub 2024 Mar 11.
PubMed 38467565
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study
- ClinicalTrials.gov ID
- NCT03261622
- Acronym / sponsor ID
- SNS / 005
- Conditions
- Faecal Incontinence, Fecal Incontinence
- Keywords
- Sacral Nerve Stimulation, Sacral Nerve Modulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Tromso, Hvidovre University Hospital
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 25 Aug 2017 (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.
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI).
In a selected patient group we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP.
Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.
During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized in a 1 to 2 pattern. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.
Detailed description
Sacral nerve stimulation (SNS) has over the last 20 years been recognised as an efficient treatment option for faecal incontinence (FI). The therapy is recommended by the International Continence Society (ICS) if conservative treatments such as; regulation of diet and fibre supplements, medication, biofeedback therapy, glycerol suppositories, mini enema or transanal irrigation have been insufficient to improve continence to a satisfactory level.
The SNS therapy has traditionally been applied as a two step procedure. Firstly, a 3-4 week test-period, often with a permanent electrode with tines, followed by permanent implantation if at least a 50% symptom reduction has been obtained during the test stimulation.
In a selected patient group(idiopathic faecal incontinence or incontinence as a result of an external anal sphincter tear (<160 degrees)) we have evidence that 90% of patients will have a successful test period (≥50% reduction in incontinence episodes). If preoperative there is motor response on at least 3 out of 4 poles on the lead, at a threshold ≤1.5 mAMP(unpublished data, submitted for publication) .
Thus, only 10% of the patients have the lead explanted after 3 to 4 weeks. In 90% of the patients a pacemaker is implanted after the test period, these patients will have an additional operation that could have been avoided if they had the permanent pacemaker implanted at the first stage.
Hypotheses In a selected patient group suffering from faecal incontinence a one-stage permanent implant will be possible. The functional results will be improved as more time can be spent finding the optimal pacemaker settings as the risk of infection is reduced compared to the stage implant. One-Stage implantation gives the opportunity to test the amount of placebo effect with SNS.
During the first 3 months postoperative patients will be randomized to either stimulation amplitude set at 90% of sensory threshold (control group) or 3 periods of stimulation at 0.05v (placebo), 50% and 90% of sensory threshold. Patients are randomized. After the initial 3 months the stimulation amplitude is increased to sensory threshold. After six months the project ends and the number of patients achieving the 50% improvement in incontinence episodes are evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized to either control group (Stimulation amplitude at 90% of sensory threshold) or intervention arm (different stimulation amplitude - 0.05 V, 50 and 90% of sensory threshold)
| Arm | Type | Receives |
|---|---|---|
| Control arm | Active comparator | Device: Sacral nerve stimulation at different stimulation amplitudesStimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks) |
| Intervention arm | Sham comparator | Device: Sacral nerve stimulation at different stimulation amplitudesAlternation of stimulation amplitude 1. Period - Stimulation amplitude 0.05 Volts (lowest possible) 2. Period - Stimulation amplitude - 50% of sensory threshold. 3. Period - Stimulation amplitude - 90% of sensory threshold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years
- Informed consent
- Idiopathic faecal incontinence or incontinence following external sphincter tear ≤ 160 degrees.
- ≥ one faecal incontinence episode after optimized conservative treatment.
- Ability to use the patient programmer.
Key exclusion criteria (5 listed)
- Pregnancy
- Diabetes
- Neurological diseases, including spinal cord injuries
- Pelvic irradiation
- Rectal resections
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 |
|---|---|---|
| Sacral nerve stimulation at different stimulation amplitudesExploring the effect of different stimulation amplitude in a randomized study | Device | Control arm, Intervention arm |
Primary outcome
Bowel Habit Diary changes
Time frame: 12 weeks
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Bowel Habit Diary changes
Time frame: 4 weeks
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
7 secondary outcomes
Bowel Habit Diary
Time frame: 24 weeks
Functional outcome measure - Wexner Incontinence score
Time frame: 4, 8, 12, and 24 weeks
Functional outcome measure - St. Marks incontinence score
Time frame: 4, 8, 12, and 24 weeks
Quality of Life FI - specific
Time frame: 4, 8, 12, and 24 weeks
Changes in functional outcome - Urin incontinence (UI).
Time frame: 4, 8, 12, and 24 weeks
Visual analogue score (VAS score): patients overall satisfaction
Time frame: 4, 8, 12, and 24 weeks
Anal physiology test
Time frame: baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)
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 2 Nov 2023.
- Derived from this study: PubMed 41444840Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S, Sorensen M, Rydningen M. Sacral neuromodulation with ultra-low stimulation intensity is effective in faecal incontinence - results from a randomised study with a one-stage implant procedure. Tech Coloproctol. 2025 Dec 24;30(1):18. doi: 10.1007/s10151-025-03254-9.
- Derived from this study: PubMed 38467565Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S, Sorensen M, Rydningen M. One-stage implant in sacral neuromodulation for faecal incontinence - short-term outcome from a prospective study. Colorectal Dis. 2024 May;26(5):968-973. doi: 10.1111/codi.16936. Epub 2024 Mar 11.
- Individual participant dataSharing planned: Yes. All participants in the study group have access to the data and if agreed in the study group sub-analysis can be made after the trial has ended.
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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.
Jakob K. Jakobsen, MD. Ph.D. principal investigator
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral nerve stimulation at different stimulation amplitudes in people with Faecal Incontinence and Fecal Incontinence, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 5 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 2 Nov 2023. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Bowel Habit Diary changes (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03261622, which also lists 2 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 2 Nov 2023.