Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective

Not Applicable

Completed

• Conditions: Fecal Incontinence; Faecal Incontinence
• Interventions: Device: Sacral nerve stimulation at different stimulation amplitudes

• Registration Number: NCT03261622
• Lead Sponsor: University of Aarhus

Brief 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). 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 Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-25
• Primary Completion: 2019-11-01
• Study Completion: 2020-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

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Exclusion Criteria

• Pregnancy
• Diabetes
• Neurological diseases, including spinal cord injuries
• Pelvic irradiation
• Rectal resections

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Sacral nerve stimulation at different stimulation amplitudes	Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)
Intervention arm	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.

Primary Outcome Measures

Name	Time	Method
Bowel Habit Diary changes	4 weeks	Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Bowel Habit Diary	24 weeks	Change in number of incontinence episodes(Bowel Habit diary - ≥50% reduction in fecal incontinence episodes), compared to baseline.
Functional outcome measure - St. Marks incontinence score	4, 8, 12, and 24 weeks	Changes in St. Marks incontinence score, compared to baseline.
Changes in functional outcome - Urin incontinence (UI).	4, 8, 12, and 24 weeks	ICIQ_UI Short form,
Visual analogue score (VAS score): patients overall satisfaction	4, 8, 12, and 24 weeks	VAS-score (0-100) for patients satisfaction with overall: * Social function; * Bowel function; * Quality of life Baseline value used as reference
Anal physiology test	baseline, 4,8,12 and 25 weeks after implantation(Only in patients implanted in Aarhus, Denmark)	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
Functional outcome measure - Wexner Incontinence score	4, 8, 12, and 24 weeks	Changes in Wexner incontinence score, compared to baseline.
Quality of Life FI - specific	4, 8, 12, and 24 weeks	Changes in Rockwood Faecal Incontinence Quality of Life score, compared to baseline

Trial Locations

Locations (1)

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital; 🇩🇰 Aarhus, Aarhus C, Denmark