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

2014-08-27 03:14:54 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science


Regional Cerebral Blood Flow


Medtronic InterStim II - 3058


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




University of Aarhus

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:54-0400

Clinical Trials [1978 Associated Clinical Trials listed on BioPortfolio]

Effects of Docosahexaenoic Acid (DHA)-Rich Fish Oil on Cerebral Haemodynamics

DHA has previously been shown to increase regional cerebral blood flow response to tactile stimulation in aged monkeys; modulation of cerebral blood flow in humans has yet to be demonstrat...

Patient Registry to Study the Tined Lead Used With the InterStim System For Urinary Control

The purpose of this study is assess the long-term safety and effectiveness of the InterStim tined lead using a minimally invasive approach.

Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

Study to Evaluate the Efficacy and Safety of P-3058 Nail Solution in the Treatment of Onychomycosis

The aim of this phase III study is to establish the efficacy and safety of P-3058 (terbinafine 10% nail solution) topically administered once weekly in patients with onychomycosis in compa...

InterStim® Amplitude Study

This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

PubMed Articles [12160 Associated PubMed Articles listed on BioPortfolio]

Predicting the occurrence of hemorrhagic cerebral hyperperfusion syndrome using regional cerebral blood flow after direct bypass surgery in patients with moyamoya disease.

Superficial temporal artery-middle cerebral artery (STA-MCA) anastomosis is an established treatment for moyamoya disease (MMD). However, hemorrhagic cerebral hyperperfusion syndrome (CHS) leads to po...

Montreal Cognitive Assessment score correlates with regional cerebral blood flow in post-stroke patients.

Valid and reliable measures are needed to assess post-stroke cognitive impairment. The Montreal Cognitive Assessment (MoCA) has been considered a superior screening test to the Mini-Mental State Exami...

Evaluation of the default-mode network by quantitative O-PET: comparative study between cerebral blood flow and oxygen consumption.

Resting-state functional MRI (rs-fMRI) has revealed the existence of a default-mode network (DMN) based on spontaneous oscillations of the blood oxygenation level-dependent (BOLD) signal. The BOLD sig...

Regional cerebral effects of ketone body infusion with 3-hydroxybutyrate in humans: Reduced glucose uptake, unchanged oxygen consumption and increased blood flow by positron emission tomography. A randomized, controlled trial.

Ketone bodies are neuroprotective in neurological disorders such as epilepsy. We randomly studied nine healthy human subjects twice-with and without continuous infusion of 3-hydroxybutyrate-to define ...

Relationship between cerebral blood flow estimated by transcranial Doppler ultrasound and single photon emission computed tomography in elderly with dementia.

Transcranial Doppler (TCD) ultrasonography is a non-invasive technique allowing continuous recording of cerebral blood flow (CBF) velocity. However, it is unclear whether the CBF estimated by TCD woul...

Medical and Biotech [MESH] Definitions

The flow of BLOOD through or around an organ or region of the body.

A gamma-emitting radionuclide imaging agent used in the evaluation of regional cerebral blood flow and in non-invasive dynamic biodistribution studies and myocardial imaging. It has also been used to label leukocytes in the investigation of inflammatory bowel diseases.

A non-invasive technique using ultrasound for the measurement of cerebrovascular hemodynamics, particularly cerebral blood flow velocity and cerebral collateral flow. With a high-intensity, low-frequency pulse probe, the intracranial arteries may be studied transtemporally, transorbitally, or from below the foramen magnum.

Methods for visualizing REGIONAL BLOOD FLOW, metabolic, electrical, or other physiological activities in the CENTRAL NERVOUS SYSTEM using various imaging modalities.

Brain dysfunction or damage resulting from sustained MALIGNANT HYPERTENSION. When BLOOD PRESSURE exceeds the limits of cerebral autoregulation, cerebral blood flow is impaired (BRAIN ISCHEMIA). Clinical manifestations include HEADACHE; NAUSEA; VOMITING; SEIZURES; altered mental status (in some cases progressing to COMA); PAPILLEDEMA; and RETINAL HEMORRHAGE.

More From BioPortfolio on "Cerebral Responses During Bilateral/Unilateral Sacral Nerve Stimulation for Idiopathic Faecal Incontinence"

Quick Search


Relevant Topics

Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Searches Linking to this Trial