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

October 31, 2023 updated by: Jakob Jakobsen, University of Aarhus

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

  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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bowel Habit Diary
Time Frame: 24 weeks
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
Time Frame: 4, 8, 12, and 24 weeks
Changes in Wexner incontinence score, compared to baseline.
4, 8, 12, and 24 weeks
Functional outcome measure - St. Marks incontinence score
Time Frame: 4, 8, 12, and 24 weeks
Changes in St. Marks incontinence score, compared to baseline.
4, 8, 12, and 24 weeks
Quality of Life FI - specific
Time Frame: 4, 8, 12, and 24 weeks
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).
Time Frame: 4, 8, 12, and 24 weeks
ICIQ_UI Short form,
4, 8, 12, and 24 weeks
Visual analogue score (VAS score): patients overall satisfaction
Time Frame: 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
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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Tromso
Hvidovre University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jakob K. Jakobsen, MD. Ph.D., Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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