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Completed

NCT Number: NCT01254695

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

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic InterStim / InterStim II

Device

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

Other names: Medtronic InterStim, Medtronic InterStim II

Primary outcomes

  1. Quality of life changes

    Time frame: Will be assessed every four weeks during a twenty-week period

    Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.

Secondary outcomes

  1. Number of incontinence episodes

    Time frame: Will be assessed every four weeks durring a twenty-week period

    Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated five times during the twenty-week protocol perioed.

  2. Days with faecal soiling

    Time frame: Will be assessed every four weeks during a twenty-week period

    By means of a four week bowel habit diary

  3. Days with faecal urgency.

    Time frame: Will be assessed every four weeks during a twelve-week period

    By means of a four week bowel habit diary

  4. Wexner incontinence score

    Time frame: Will be assessed every four weeks during a twenty-week period

  5. St. Marks Incontinence score

    Time frame: Will be assessed every four weeks during a twenty-week period

  6. Assess changes in anorectal volume and pressure with different pacemaker settings

    Time frame: Will be assessed every four weeks during a twenty-week period

    Resting, maximal anal sphincter pressure and rectal filling(first sensation, urge to defacate and maximal tolerabel volume(Air))pressure will be measured with different pacemaker settings. In total five evaluations will be made in the twenty week protocol perioed.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • London North West Healthcare NHS Trust

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 6, 2010
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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