Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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.

Official Title
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Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective: A Randomized Blinded Study

Conditions
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Faecal Incontinence, Fecal Incontinence

Intervention / Treatment
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* Device: Sacral nerve stimulation at different stimulation amplitudes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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. Exclusion Criteria: Pregnancy Diabetes Neurological diseases, including spinal cord injuries Pelvic irradiation Rectal resections

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks) | Device: Sacral nerve stimulation at different stimulation amplitudes<br>* Exploring the effect of different stimulation amplitude in a randomized study<br>|
| Sham Comparator: Intervention arm<br>Alternation of stimulation amplitude Period - Stimulation amplitude 0.05 Volts (lowest possible) Period - Stimulation amplitude - 50% of sensory threshold. Period - Stimulation amplitude - 90% of sensory threshold. | Device: Sacral nerve stimulation at different stimulation amplitudes<br>* Exploring the effect of different stimulation amplitude in a randomized study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Habit Diary changes | Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline. | 12 weeks | 
| Bowel Habit Diary changes | Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Habit Diary | Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline. | 24 weeks | 
| Functional outcome measure - Wexner Incontinence score | Changes in Wexner incontinence score, compared to baseline. | 4, 8, 12, and 24 weeks | 
| Functional outcome measure - St. Marks incontinence score | Changes in St. Marks incontinence score, compared to baseline. | 4, 8, 12, and 24 weeks | 
| Quality of Life FI - specific | Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline | 4, 8, 12, and 24 weeks | 
| Changes in functional outcome - Urin incontinence (UI). | ICIQ_UI Short form, | 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 | 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 | baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral Nerve Stimulation, Sacral Nerve Modulation