Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective (SNS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Faecal Incontinence
• Intervention / Treatment: Device: Sacral nerve stimulation at different stimulation amplitudes

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus C
    • Aarhus, Aarhus C, Denmark, 8000
      • Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control arm; Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)	Device: Sacral nerve stimulation at different stimulation amplitudes; Exploring the effect of different stimulation amplitude in a randomized study
Sham Comparator: Intervention arm; 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; Exploring the effect of different stimulation amplitude in a randomized study

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: University of Tromso; Hvidovre University Hospital
• Investigators: Principal Investigator: Jakob K. Jakobsen, MD. Ph.D., Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Sacral Nerve Modulation; Sacral Nerve Stimulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No