Comparison of Sacral Nerve Modulation and Pudendal Nerve Stimulation in Treatment of Fecal Incontinence
Summary
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 patients failing SNM treatment of urinary dysfunction (Spinelli 2005). In this study SNM and PNS are compared for the treatment of fecal incontinence. In a test phase, both treatments will be applied for one week each in a randomized and blinded order (cross-over design). After the test phase the more successful treatment will be determined and applied permanently. If both treatments are equally sufficient, PNS will be chosen for permanent stimulation, since preliminary data indicate that PNS has a lower power consumption than SNM. Lower power consumption results in a longer lifetime of the stimulator, thus requiring less replacement surgeries.
Description
Primary Surgery:
- Implantation of two electrodes, one placed next to the sacral nerve, one close to the pudendal nerve. Electrode wires are passed through the skin just above the gluteal region and are marked S and P. One of the sub-investigators (not involved in the follow-up) replaces the S and P marks by 1 and 2 marks in absence of the operating surgeon. Assignment of 1 and 2 is carried out in a predefined randomized fashion (computerized block randomization).
Test phase:
- Electrode labeled 1 is connected to a stimulator and the nerve is stimulated for one week, then the other electrode is stimulated for a week.
- Based on bowel habit diary, Wexner score (Jorge 1993) and subjective experience of the patient, the more successful treatment is chosen. If both electrodes were equally successful, the pudendal nerve electrode will be chosen for permanent stimulation.
Secondary surgery:
- After unblinding, the less effective electrode is removed and the remaining electrode is connected to an implanted stimulator (permanent phase). In case both treatments were unsuccessful, both electrodes are removed.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Fecal Incontinence
Intervention
Sacral nerve modulation, Pudendal nerve stimulation
Location
Department of Surgey, Cantonal Hospital St. Gallen
St.Gallen
Switzerland
9007
Status
Recruiting
Source
Cantonal Hospital of St. Gallen
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01069016
- 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.
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.
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.
Nerve Fibers, Myelinated
A class of nerve fibers as defined by their structure, specifically the nerve sheath arrangement. The AXONS of the myelinated nerve fibers are completely encased in a MYELIN SHEATH. They are fibers of relatively large and varied diameters. Their NEURAL CONDUCTION rates are faster than those of the unmyelinated nerve fibers (NERVE FIBERS, UNMYELINATED). Myelinated nerve fibers are present in somatic and autonomic nerves.
Accessory Nerve Diseases
Diseases of the eleventh cranial (spinal accessory) nerve. This nerve originates from motor neurons in the lower medulla (accessory portion of nerve) and upper spinal cord (spinal portion of nerve). The two components of the nerve join and exit the skull via the jugular foramen, innervating the sternocleidomastoid and trapezius muscles, which become weak or paralyzed if the nerve is injured. The nerve is commonly involved in MOTOR NEURON DISEASE, and may be injured by trauma to the posterior triangle of the neck.
Clinical Trials
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 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
Sacral Nerve Stimulation Therapy for the Treatment of Chronic Fecal Incontinence
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 exper...
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und...
Tibial Nerve Stimulation for Faecal Incontinence
The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.
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...
Surgical location and anatomical variations of pudendal nerve.
BACKGROUND: An objective of our work was to clarify variations in pudendal nerve formation, as well as their possible impact on the clinical picture. METHOD: Bilateral pudendal nerve course and format...
Neuralgia of the pudendal nerve following violent trauma : Analgesia by pudendal neuromodulation.
Pudendal neuralgia is a neuropathic disease which is predominantly caused by pelvic trauma with pressure or stretching strain of the pudendal nerve. The Nantes criteria are used for the differential d...
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...
