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

NCT ID: NCT01254695

Last Updated: 2011-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard settings

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

Group Type ACTIVE_COMPARATOR

Medtronic InterStim / InterStim II

Intervention Type DEVICE

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Experimental Setting 1

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

Group Type EXPERIMENTAL

Medtronic InterStim / InterStim II

Intervention Type DEVICE

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Experimental setting 2

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

Group Type EXPERIMENTAL

Medtronic InterStim / InterStim II

Intervention Type DEVICE

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Experimental setting 3

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

Group Type EXPERIMENTAL

Medtronic InterStim / InterStim II

Intervention Type DEVICE

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Experimental setting 4

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

Group Type EXPERIMENTAL

Medtronic InterStim / InterStim II

Intervention Type DEVICE

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Interventions

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Medtronic InterStim / InterStim II

Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4

Intervention Type DEVICE

Other Intervention Names

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Medtronic InterStim Medtronic InterStim II

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London North West Healthcare NHS Trust

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakob k Jakobsen, MD.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, Aarhus C, Denmark

Site Status

St. Marks Hospital

London, Harrow - Middlesex, United Kingdom

Site Status

Countries

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Denmark United Kingdom

References

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Duelund-Jakobsen J, Dudding T, Bradshaw E, Buntzen S, Lundby L, Laurberg S, Vaizey C. Randomized double-blind crossover study of alternative stimulator settings in sacral nerve stimulation for faecal incontinence. Br J Surg. 2012 Oct;99(10):1445-52. doi: 10.1002/bjs.8867.

Reference Type DERIVED
PMID: 22961528 (View on PubMed)

Other Identifiers

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004

Identifier Type: -

Identifier Source: org_study_id