Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters

University of Aarhus

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: Medtronic InterStim / InterStim II

Study type: Interventional

Funder types: Other

Identifiers

NCT01254695

004

Details and patient eligibility

About

Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.

Full description

Faecal incontinence is a devastating condition affecting daily living and has major influences on quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.

The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.

Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed Consent
• Diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
• Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
• minimum one incontinence episodes pr. week during ongoing SNS-therapy

Exclusion criteria

• Colorectal surgery after IPG-implantation
• Pregnancy or breastfeeding
• Anal/perianal pain or discomfort
• Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
• Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliac, neurological disorders.
• Spinal cord injury
• Irritable Bowel Syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 5 patient groups

Standard settings

Active Comparator group

Description:

Amplitude: Sensory threshold Frequency:14 Hz Pulse width 210 μsec

Treatment:

Device: Medtronic InterStim / InterStim II

Experimental Setting 1

Experimental group

Description:

Amplitude: Sensory threshold Frequency:6.9 Hz Pulse width 210 μsec

Treatment:

Device: Medtronic InterStim / InterStim II

Experimental setting 2

Experimental group

Description:

Amplitude: Sensory threshold Frequency:31 Hz Pulse width 210 μsec

Treatment:

Device: Medtronic InterStim / InterStim II

Experimental setting 3

Experimental group

Description:

Amplitude: Sensory threshold Frequency:14 Hz Pulse width 330 μsec

Treatment:

Device: Medtronic InterStim / InterStim II

Experimental setting 4

Experimental group

Description:

Amplitude: Sensory threshold Frequency:14 Hz Pulse width 90 μsec

Treatment:

Device: Medtronic InterStim / InterStim II