Abstract
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
| Original language | English |
|---|---|
| Pages (from-to) | 310-314 |
| Number of pages | 5 |
| Journal | Techniques in Coloproctology |
| Volume | 11 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Dec 2007 |
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Keywords
- Alerting system
- Anal plug
- Fecal incontinence
- Non-surgical device
ASJC Scopus subject areas
- Gastroenterology
- Surgery
Cite this
The ProTect device in the treatment of severe fecal incontinence : Preliminary results of a multicenter trial. / Giamundo, P.; Altomare, D. F.; De Nardi, P.; D'Onofrio, V.; Infantino, A.; Pucciani, F.; Rinaldi, M.; Romano, G.
In: Techniques in Coloproctology, Vol. 11, No. 4, 12.2007, p. 310-314.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The ProTect device in the treatment of severe fecal incontinence
T2 - Preliminary results of a multicenter trial
AU - Giamundo, P.
AU - Altomare, D. F.
AU - De Nardi, P.
AU - D'Onofrio, V.
AU - Infantino, A.
AU - Pucciani, F.
AU - Rinaldi, M.
AU - Romano, G.
PY - 2007/12
Y1 - 2007/12
N2 - 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
AB - 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
KW - Alerting system
KW - Anal plug
KW - Fecal incontinence
KW - Non-surgical device
UR - http://www.scopus.com/inward/record.url?scp=38649109831&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=38649109831&partnerID=8YFLogxK
U2 - 10.1007/s10151-007-0371-9
DO - 10.1007/s10151-007-0371-9
M3 - Article
C2 - 18060592
AN - SCOPUS:38649109831
VL - 11
SP - 310
EP - 314
JO - Techniques in Coloproctology
JF - Techniques in Coloproctology
SN - 1123-6337
IS - 4
ER -