Fecal Incontinence Clinical Trial
Official title:
Treatment of Idiopathic Faecal Incontinence With Sacral Nerve Stimulation - Improved Function With Implantation and Stimulation of Permanent Electrodes Bilaterally - a Double-blinded Randomized Cross-over Trial
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 population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, sacral nerve stimulation (SNS), has over the last decade given hope to these patients. The treatment is divided in two; first a test operation (PNE-test) has to reveal if the patient will benefit from treatment with permanent sacral nerve stimulation. Second if the patient benefit from the PNE-test, they proceed to final implant. 75-80% of the patients with idiopathic fecal incontinence benefit from the PNE-test, 70% of those get satisfactory functional results and the remaining 30% get suboptimal improvement in continence after permanent unilateral sacral nerve stimulation. The aim of this project is to investigate if bilateral sacral nerve stimulation can produce better fecal continence results than standard unilateral stimulation, through a double blind, randomized crossover study.
Sacral nerve stimulation is a very good and effective treatment for faecal incontinence The
method was introduced to patients with voiding disorders in 1981. In 1995 sacral nerve
stimulation was used for three patients with faecal incontinence, two were afterwards fully
continent. The method has over the last decade been used increasingly in Europe. The method
is now used routinely in the treatment of faecal incontinence in Europe.
Recent studies have shown that the effect of sacral nerve stimulation is due to a
neuromodulation in the central nervous system, whereas direct stimulation of efferent nerves
to anal sphincter and the pelvic floor has less significance.
The sacral nerve stimulation is performed in two steps, first a test stimulation, if
positive the patients proceed to permanent implant.
Test stimulation (PNE-test) is performed over a 3 week period. If this test stimulation
produces a decrease in incontinence episodes of more than 50 per cent, a permanent electrode
and neurostimulator are implanted. The test period has a success rate of approximately
75-80% in patients with idiopathic fecal incontinence or incontinence after anal surgery.
These 75-80% will normal be candidates to unilateral implantation of permanent electrode and
neurostimulator.
All permanently implanted has less incontinence symptoms after the treatment. Satisfactory
continence results after permanent implantation are seen in 70% of the patients, the
remaining 30% only obtain a suboptimal efficacy. It is unclear whether these patients could
have a more optimal function if they were stimulate on more than one sacral nerve
simultaneously.
Hypothesis: Is it possible to improve the functional result in faecal incontinent patients
treated with routine unilateral sacral nerve stimulation by stimulating the sacral nerves
bilaterally.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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