Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
Summary
Fecal incontinence (FI) is a difficulty in storing gas, liquid stool or solid stool (bowel movement) in order to expel it at a proper time and place. Patients who suffer from FI may experience passive FI (difficulty in sensing stool in the rectum) or urgency (able to sense a bowel movement but cannot hold the stool until an acceptable time and place). FI is not a life-threatening disease, but it is often profoundly distressing and socially incapacitating.
If a patient is suffering with symptoms of chronic FI despite trying oral medications, biofeedback and/or other more conservative treatments, a patient may be eligible to participate in a clinical research study to evaluate the safety and effectiveness of sacral nerve stimulation for the treatment of chronic fecal incontinence. One hundred-twenty (120) patients will be implanted with medical devices and followed closely for twelve months, and then once a year after that until the study closes. There are up to 20 centers in the United States.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Fecal Incontinence
Intervention
InterStim Sacral Nerve Stimulation Therapy
Location
Contact Medtronic for specific site information
Los Angeles
California
United States
Status
Active, not recruiting
Source
MedtronicNeuro
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00200057
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sciatic Nerve
A nerve which originates in the lumbar and sacral spinal cord (L4 to S3) and supplies motor and sensory innervation to the lower extremity. The sciatic nerve, which is the main continuation of the sacral plexus, is the largest nerve in the body. It has two major branches, the TIBIAL NERVE and the PERONEAL NERVE.
Pelvic Organ Prolapse
Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.
Tibial Nerve
The medial terminal branch of the sciatic nerve. The tibial nerve fibers originate in lumbar and sacral spinal segments (L4 to S2). They supply motor and sensory innervation to parts of the calf and foot.
Epidural Abscess
Circumscribed collections of suppurative material occurring in the spinal or intracranial EPIDURAL SPACE. The majority of epidural abscesses occur in the spinal canal and are associated with OSTEOMYELITIS of a vertebral body; ANALGESIA, EPIDURAL; and other conditions. Clinical manifestations include local and radicular pain, weakness, sensory loss, URINARY INCONTINENCE, and FECAL INCONTINENCE. Cranial epidural abscesses are usually associated with OSTEOMYELITIS of a cranial bone, SINUSITIS, or OTITIS MEDIA. (From Adams et al., Principles of Neurology, 6th ed, p710 and pp1240-1; J Neurol Neurosurg Psychiatry 1998 Aug;65(2):209-12)
Tarlov Cysts
Perineurial cysts commonly found in the SACRAL REGION. They arise from the PERINEURIUM membrane within the SPINAL NERVE ROOTS. The distinctive feature of the cysts is the presence of spinal nerve root fibers within the cyst wall, or the cyst cavity itself.
Clinical Trials
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Faecal incontinence is a devastating condition causing psychological stress, affecting daily living and influences quality of life. Faecal incontinence affects 2,2 to 5 % of the adult popu...
Sacral nerve modulation (SNM) is an established treatment for refractory lower urinary tract and bowel dysfunction (Spinelli 2008). Pudendal nerve stimulation (PNS) has been proposed for p...
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 stim...
Comparison of Motor and Sensory Response With Interstim Stimulation
Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has current FDA approval for urinary urge incontinence, urgency-frequency syndrome and non-obstructive u...
PubMed Articles
Sphincteroplasty for fecal incontinence in the era of sacral nerve modulation.
The role of sphincteroplasty in the treatment of patients with fecal incontinence due to anal sphincter defects has been questioned because the success rate declines in the long-term. A new emerging t...
Sacral nerve stimulation (SNS) has become an established therapy worldwide for the treatment for fecal incontinence. A large number of papers have been published over the years, and SNS is generally c...
Sacral nerve stimulation during pregnancy in patients with severe fecal incontinence.
Sacral neuromodulation in urology : The emperor's new clothes or effective high-tech medicine?
Sacral nerve modulation (SNM) is an innovative, minimally invasive treatment that uses chronic low-level electrical stimulation of the sacral plexus to recruit residual physiological function of urina...
