Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01095029
First received: March 22, 2010
Last updated: July 3, 2014
Last verified: March 2012
  Purpose

The purpose of this study is to determine whether Sacral Nerve Stimulation (SNS) for idiopathic faecal incontinence affect cortical and deep brain activity in an acute and chronically stimulation model. Furthermore the association between brain activity and unilateral/bilateral SNS will be studied in each patient. Brain activity will be studied by use of positron emission tomography.


Condition Intervention
Regional Cerebral Blood Flow
Fecal Incontinence
Device: Medtronic InterStim II - 3058

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence - Assessed With Positron Emission Tomography Scan (PET-scan)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Changes in Regional Cerebral Blood Flow with different pacemaker settings [ Time Frame: 12 weeks after study enrolment ] [ Designated as safety issue: No ]
    RCBF evaluated with positron emission tomography.


Secondary Outcome Measures:
  • Changes in continence and quality of life with different pacemaker activation. [ Time Frame: 12 weeks after study enrolment ] [ Designated as safety issue: No ]
    Changes in incontinence episodes and quality of life will be correlated to changes in RCBF with different pacemaker activation.


Enrollment: 10
Study Start Date: February 2010
Study Completion Date: July 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Off/Off
Pacemaker status: Bilateral Off for four weeks before first PET scann.
Device: Medtronic InterStim II - 3058
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
Experimental: On/On
Pacemaker status: Bilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Device: Medtronic InterStim II - 3058
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
Experimental: On/Off
Pacemaker status: Unilateral On. PET scan one hour after activation and after four weeks continuous stimulation.
Device: Medtronic InterStim II - 3058
Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.

Detailed Description:

Faecal incontinence is a devastating condition affecting daily living and quality of life. A new treatment Sacral Nerve Stimulation (SNS) has over the last decade given new hope to these patients. In Europe SNS is routinely offered to patients not archiving satisfactory continence result with standard non-surgical treatments. SNS is electrical stimulation of the sacral nerve root(s2,3 or 4). Stimulation of this nerve roots results in improved continence. The mechanism of action is at present not well described. Recent studies have shown that the effect of SNS is by means a neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves to the anal sphincter and the pelvic floor has less significance.

The aim of this study is to describe changes in regional cerebral blood flow (RCBF), with positron emission tomography (PET), in patients implanted bilaterally with sacral neuromodulators with the indication idiopathic faecal incontinence.

RCBF in three deferent stimulations settings will be compared. PET will be performed before and one hour after changes in the activity status of the pacemakers. Four weeks prior to the first scan, patients are informed to switch both neurostimulator off. PET will be performed with the pacemaker settings: OFF/OFF (Stimulation status of left/right pacemaker), On/Off and On/On. The order of the On/OFF and On/On period will be random. Unilateral stimulation will be performed with the pacemaker there has the best efficacy, determined prior to study enrolment. The interval between these three pacemaker settings is four weeks. Four weeks prior to each PET scan the patients fill in bowel habit diaries, bowel habit questionnaires and quality of life assessments.

The association between continence and changes in RCBF will be studied. Additional RCBF and quality of life will be compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Informed consent
  • Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
  • Permanent neuromodulator (medtronic InterStim II) bilateral implanted
  • Reduction in fecal incontinence episodes of at least 50% between baseline and latest follow up with unilateral stimulation(Bowel diary card)
  • Willing and competent to fill out diary cards
  • MR-cerebrum before implantatation of neuromodulator
  • Right-handed dominant

Exclusion Criteria:

  • Colorectal/proctological surgery since IPG-implant
  • Pregnancy
  • Neurological diseases including spinal cord injury.
  • Use of medication with known alternation of gastrointestinal motilitet (thyroid, diabetes, neuroleptica)
  • Claustrofobia
  • Latex allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095029

Locations
Denmark
Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Jakob K Jakobsen, MD. Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01095029     History of Changes
Other Study ID Numbers: 003
Study First Received: March 22, 2010
Last Updated: July 3, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Positron emission tomography (PET)
Idiopathic Faecal Incontinence
Bilateral Sacral Nerve Stimulation
Sacral Nerve Stimulation
Sacral Nervemodulation

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014