Sacral Nerve Stimulation May Be Helpful for Fecal Incontinence CME

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Sacral Nerve Stimulation May Be Helpful for Fecal Incontinence CME

News Author: Laurie Barclay, MD

CME Author: Vega, MD, FAAFP

Complete author affiliations and disclosures, and other CME information, are

available at the end of this activity.

Release Date: April 20, 2004; Valid for credit through April 20, 2005

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April 20, 2004 ‹ Sacral nerve stimulation is safe and effective for the

treatment of fecal incontinence, according to the results of a small

multicenter trial published in the April 17 issue of The Lancet.

" Our trial has shown a convincing benefit of sacral nerve stimulation to

continence and quality of life for patients with fecal incontinence, " lead

author Klaus E. Matzel, from the University of Nuremberg in Germany, says in

a news release. " The technique is relatively simple, and its practicality is

enhanced by the predictive value of a staged approach, in which every

patient serves as his or her own control. "

Anal incontinence affects an estimated 2% of the general population, and its

prevalence increases with age to 11% of men and 26% of women after age 50

years. When conservative treatment such as dietary change and pelvic-floor

exercise fails, therapeutic options have been limited to date.

In this study, 34 patients from eight medical centers had electrodes

implanted for sacral nerve stimulation, and they kept a record of

incontinence episodes for up to three years after starting treatment.

Sacral nerve stimulation reduced the mean number of weekly episodes of

incontinence, from 16.4 per week at study entry to 3.1 per week after one

year of treatment and 2.0 per week at two year follow-up (P < .0001). The

average number of incontinent days per week and use of incontinence pads

also decreased, while the ability to postpone defecation and quality-of-life

scores improved (P < .0001 for all).

Infection was the most serious complication, but overall risk of serious

complications was limited.

Study limitations include prospective design, lack of randomized control

group, and limited generalizability to other groups.

" With its low morbidity, sacral nerve stimulation is a safe and effective

option for patients with an intact or repaired anal sphincter, " Dr. Matzel

says. " When conventional treatment is inappropriate or ineffective, it

should be considered before sphincter replacement or stoma creation. "

Bakken Research Center supported this study. One author is an employee of

Medtronic, and four authors are consultants to Medtronic.

Lancet. 2004;363:1270-1276

Learning Objectives

Upon completion of this activity, participants will be able to:

* Describe treatment options for fecal incontinence.

* Evaluate the efficacy and safety of sacral nerve stimulation in the

management of fecal incontinence.

Clinical Context

Fecal incontinence is a common problem that will become even more important

as the U.S. population ages. Several treatment options exist for fecal

incontinence, according to a review by Kamm that appeared in the Feb. 14,

1998, issue of the British Medical Journal. He suggests either loperamide or

codeine for mild or infrequent symptoms. Although biofeedback has been shown

to improve symptoms of fecal incontinence, many of the studies demonstrating

efficacy have been of poor quality. Surgery, usually accomplished by

transposing a muscle such as the gracilis or gluteus around the anal canal

to increase resting pressure, can produce continence levels above 70%.

Sacral spinal nerve stimulation also has been demonstrated to be effective

in the treatment of fecal incontinence, but studies have been performed in

single centers with limited numbers of patients. The authors of the current

study sought to determine the efficacy and safety of sacral nerve

stimulation in a multicenter trial.

Study Highlights

* The study was not randomized and was conducted in 8 different centers

simultaneously. All patients were adults with fecal incontinence, defined by

involuntary passage of feces at least once a week. Subjects had to have an

intact external anal sphincter. Patients were excluded from study

participation if they had a history of congenital anorectal malformation,

previous rectal surgery, or chronic bowel or neurologic disease.

* All participants underwent diagnostic procedures with percutaneous

stimulation to maximize the potential of the permanent neurostimulation

device. Those who achieved a 50% reduction in symptoms underwent

implantation of a permanent neurostimulator.

* The main study outcome was the frequency of fecal incontinence. The

researchers also measured staining or pad use as well as the ability to

defer defecation when necessary. Quality-of-life measures, both general and

specific for patients with fecal incontinence, were also followed. Patients

were evaluated for these outcomes as well as adverse events at 3, 6, 12, and

24 months after implantation.

* 37 patients underwent diagnostic testing. 33 of these patients were

women, and the mean age of subjects was 54.3 years. 8 patients had a

previous history of surgical procedure for fecal incontinence.

* Of the cohort of 37, 34 participants underwent permanent

neurostimulator placement. The 3 patients who dropped out of the study

protocol were either not adherent to therapy, suffered lead displacement, or

had an infection after treatment.

* A permanent lead was placed at the S3 level in 22 subjects and the S4

level in 12. The mean amplitude of stimulation was 1.65 V after activation,

but this mean level increased to 2.34 V by the end of the trial.

* Median follow-up was 23.9 months.

* The number of episodes of fecal incontinence decreased from a mean of

16.4 at baseline to 1.2 at 3 months and 2.0 at 24 months. 37% of

participants experienced a return to complete continence, and 83% of

subjects experienced a more than 50% reduction in the number of incontinence

episodes per week.

* Both urge and passive incontinence were improved to a similar degree,

and these results were comparable between participants with and without a

history of previous surgery for fecal incontinence.

* The ability to postpone defecation improved significantly with

neurostimulation, as did the rate of staining and use of pads.

* Scores on a quality-of-life scale specific for patients with fecal

incontinence were improved in all aspects at 12 and 24 months. Scores on a

standard quality-of-life scale were improved except for the variable of

bodily pain. Social functioning was the variable most improved with sacral

neurostimulation on this scale.

* 9 subjects developed infection during the screening procedure, and 4 of

these patients required lead removal.

* 12 participants experienced 19 device-related adverse events after

permanent neurostimulator placement. Pain was the most common adverse

effect, accounting for 10 episodes. One patient had an infection

necessitating removal of the device. 3 patients had a worsening of bowel

symptoms during the treatment period. 63.2% of all adverse events eventually

resolved.

Pearls for Practice

* Fecal incontinence can be treated medically when mild, but surgical

treatment is required for more severe cases.

* Sacral nerve stimulation is an effective means to reduce symptoms of

fecal incontinence.

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Target Audience

This article is intended for primary care physicians, surgeons,

gastroenterologists, and other physicians who care for patients with fecal

incontinence.

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News Author

Laurie Barclay, MD

Freelance writer for Medscape Medical News

Disclosure: Dr. Barclay has reported no significant financial interests.

CME Author

Vega, MD, FAAFP

Assistant Clinical Professor, Associate Residency Program Director,

Department of Family Medicine, University of California, Irvine

Disclosure: Dr. Vega has disclosed that he has received grants for

educational activities from Pfizer.

News CME Staff

Deborah Flapan

Assistant Managing Editor, Medscape Medical News

Disclosure: Ms. Flapan has reported no significant financial interests.

Vogin, MD

Clinical Reviewer and Senior Medical Editor, Medscape

Disclosure: Dr. Vogin has reported no significant financial interests.

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