An interventional study of Sacral nerve stimulation at different stimulation amplitudes in Faecal Incontinence and Fecal Incontinence, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science
Among 21 studies in Fecal Incontinence with a site in Denmark — 3 open to participants now, 3 under way, none of them phase 3. Fecal Incontinence · Denmark.
Among the 21 studies in Fecal Incontinence with a site in Denmark, this one is the 8th largest by enrollment of the 20 interventional ones that give a count, is the only one that started in 2016, is one of 15 with no phase, and was the 12th registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
Browse Fecal Incontinence studies →3 of the 21 studies in Fecal Incontinence with a site in Denmark are open now. Recruiting first, the newest first:
InnoCon Medical · Sites in Denmark
Ages 18+
InnoCon Medical · Sites in Denmark
Ages 18+ · Women only
Wellspect HealthCare · Sites in Denmark, France, Italy and 3 more countries
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 73 is above the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Median enrollment 32 across the 20 interventional studies, 90 across the 1 observational. Of the 16 that completed or were terminated, 2 (13%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 21 have an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 9 studies filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
1 of the studies in Fecal Incontinence with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06091566InnoCon MedicalSafety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) | 2027-01-01 |
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Among the 21 studies in Fecal Incontinence with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)
Device: Sacral nerve stimulation at different stimulation amplitudes
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.
Device: Sacral nerve stimulation at different stimulation amplitudes
Exploring the effect of different stimulation amplitude in a randomized study
Bowel Habit Diary changes
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Time frame: 12 weeks
Bowel Habit Diary changes
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Time frame: 4 weeks
Bowel Habit Diary
Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Time frame: 24 weeks
Functional outcome measure - Wexner Incontinence score
Changes in Wexner incontinence score, compared to baseline.
Time frame: 4, 8, 12, and 24 weeks
Functional outcome measure - St. Marks incontinence score
Changes in St. Marks incontinence score, compared to baseline.
Time frame: 4, 8, 12, and 24 weeks
Quality of Life FI - specific
Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline
Time frame: 4, 8, 12, and 24 weeks
Changes in functional outcome - Urin incontinence (UI).
ICIQ_UI Short form,
Time frame: 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
Time frame: 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
Time frame: baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Nov 2019, 36 months.
Of 70 non-industry interventional studies with no phase under Fecal Incontinence, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's 36 months is close to that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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