The ProTect device in the treatment of severe fecal incontinence: preliminary results of a multicenter trial.
BACKGROUND
Patients suffering from severe fecal incontinence (FI) in whom surgical treatment has either failed or is inappropriate due to high operative risks and those who refuse to undergo surgery are condemned to living with their embarrassing symptoms, often responsible for progressive social isolation. ProTect is a new, relatively simple, medical device intended for selected patients suffering from severe FI. It consists of a pliable, silicone catheter with an inflatable balloon that seals the rectum at the anorectal junction, acting like an anal plug. The proximal part of the catheter incorporates two contacts that monitor the rectum for the presence of feces. The patient is alerted to an imminent bowel movement and, hence, a potential fecal accident, through a beeper.


METHODS
A multicenter trial has been set up to assess the reliability of the device in preventing episodes of FI and to evaluate its impact on quality of life. Patients with significant FI (CCF>10) were prospectively entered into this 14-day study. Two quality of life questionnaires and a daily log of bowel activity and incontinent episodes were completed before and during the study.


RESULTS
Currently, the study enrolled 17 patients and 11 patients (9 women, 2 men) with a mean age of 66 years (range, 46-85) completed the trial. In these 11 subjects, there was an overall significant improvement in the quality of life (p<0.05) and a significant reduction in incontinence scores (p<0.001) while using ProTect compared to baseline.


CONCLUSIONS
The ProTect is a safe non-surgical device that is able to prevent episodes of FI. It is unique because it can be used according to a patient's needs without interfering with activities of daily living.
Giamundo
P
P
Department of General Surgery, Santo Spirito Hospital, Bra CN, Italy. giamundo@hotmail.com
Altomare
D F
DF
Rinaldi
M
M
De Nardi
P
P
D'Onofrio
V
V
Infantino
A
A
Pucciani
F
F
Romano
G
G
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002404:Catheterization / Q000295:instrumentation*; D003672:Defecation; D004867:Equipment Design; D005242:Fecal Incontinence / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome