The procon incontinence device: a new nonsurgical approach to preventing episodes of fecal incontinence.
OBJECTIVE
Treatment of severe fecal incontinence (FI) is essentially surgical. However, patients in whom surgery has failed, those who have high operative risks, and those who refuse to undergo surgery are often condemned to living with this embarrassing condition. The Procon incontinence device, a relatively simple, nonsurgical device, may represent a good solution in preventing episodes of FI, thus improving quality of life in these individuals. This device consists of a disposable, pliable rubber catheter with an infrared photo-interrupter sensor and flatus vent holes on the distal tip that is connected to a pager (or "beeper"). The catheter is inserted in the rectum and held in place by a 20-cc capacity cuff, which acts as a temporary mechanical barrier to stool leakage. Stool entering the rectum is sensed by the photo-interrupter sensor, which then alerts the patient to an imminent bowel movement. Voluntary evacuation is accomplished by deflating the balloon and removing the catheter. The aim of this study was to evaluate the efficacy, reliability, and safety of the Procon device in a group of patients with FI.


METHODS
Patients with significant FI who had undergone anorectal manometry, ultrasound, and electromyography with pudendal nerve terminal motor latency assessment were prospectively entered into this study. The Procon device was used for 14 consecutive days. A quality of life diary and daily log of bowel activity and incontinent episodes were completed before and after the end of the study.


RESULTS
Seven patients (five female and two male) with a mean age of 72.7 yr (range 39-81 yr) were evaluated. Etiology of incontinence included idiopathic in four patients, sphincter defect in two, and neurological disorder in one patient. There was an overall significant improvement in the quality of life (p < 0.05) and a significant reduction in incontinence scores with the Procon device (p < 0.05).


CONCLUSIONS
The Procon is a unique, safe, and promising device that is able to prevent episodes of FI without the need for surgery, thereby improving quality of life. Its role includes use in patients with severe FI who are unfit to undergo surgery, those in whom previous surgical treatments have failed, or those who do not wish to undergo surgery.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000009:adverse effects* / Q000295:instrumentation*; D004867:Equipment Design; D005242:Fecal Incontinence / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index