Sacral Nerve Stimulation for Faecal Incontinence - Placebo or Clinical Effective

NCT ID: NCT03261622

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2020-11-01

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.

Conditions

Faecal Incontinence; Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Control arm

Stimulation amplitude at 90% of sensory threshold during period 1 to 3. (each period 4 weeks)

Group Type: ACTIVE_COMPARATOR

Sacral nerve stimulation at different stimulation amplitudes

Intervention Type: DEVICE

Exploring the effect of different stimulation amplitude in a randomized study

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.

Group Type: SHAM_COMPARATOR

Sacral nerve stimulation at different stimulation amplitudes

Intervention Type: DEVICE

Exploring the effect of different stimulation amplitude in a randomized study

Interventions

Sacral nerve stimulation at different stimulation amplitudes

Exploring the effect of different stimulation amplitude in a randomized study

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tromso

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Jakob Jakobsen

Principal Investigator (M.D. Ph.D.)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jakob K. Jakobsen, MD. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Locations

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Aarhus, Aarhus C, Denmark

Countries

Denmark

Other Identifiers

005

Identifier Type: -

Identifier Source: org_study_id