The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study

W. Douglas Wong; Susan M. Congliosi; Michael P. Spencer; Marvin L. Corman; Patrick Tan; Frank G. Opelka; Marcus Burnstein; Juan J. Nogueras; H. Randolph Bailey; Jose Manuel Devesa; Robert D. Fry; Burt Cagir; Elisa Birnbaum; James W. Fleshman; Mallory A. Lawrence; W. Donald Buie; John Heine; Peter S. Edelstein; Sharon Gregorcyk; Paul Antoine Lehur; Francis Michot; P. Terry Phang; David J. Schoetz; Fabio Potenti; Josephine Y. Tsai

doi:10.1007/s10350-004-6381-z

The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study

W. Douglas Wong, Susan M. Congliosi, Michael P. Spencer, Marvin L. Corman, Patrick Tan, Frank G. Opelka, Marcus Burnstein, Juan J. Nogueras, H. Randolph Bailey, Jose Manuel Devesa, Robert D. Fry, Burt Cagir, Elisa Birnbaum, James W. Fleshman, Mallory A. Lawrence, W. Donald Buie, John Heine, Peter S. Edelstein, Sharon Gregorcyk, Paul Antoine LehurFrancis Michot, P. Terry Phang, David J. Schoetz, Fabio Potenti, Josephine Y. Tsai

Research output: Contribution to journal › Article › peer-review

245 Scopus citations

Abstract

PURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon™ artificial bowel sphincter for fecal incontinence. METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1-120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant. RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18-81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.

Original language	English (US)
Pages (from-to)	1139-1153
Number of pages	15
Journal	Diseases of the Colon and Rectum
Volume	45
Issue number	9
DOIs	https://doi.org/10.1007/s10350-004-6381-z
State	Published - Sep 2002

Keywords

Artificial bowel sphincter
Fecal incontinence
Multicenter clinical trial
Quality of life

ASJC Scopus subject areas

Gastroenterology

Access to Document

10.1007/s10350-004-6381-z

Cite this

Wong, W. D., Congliosi, S. M., Spencer, M. P., Corman, M. L., Tan, P., Opelka, F. G., Burnstein, M., Nogueras, J. J., Bailey, H. R., Devesa, J. M., Fry, R. D., Cagir, B., Birnbaum, E., Fleshman, J. W., Lawrence, M. A., Buie, W. D., Heine, J., Edelstein, P. S., Gregorcyk, S., ... Tsai, J. Y. (2002). The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study. Diseases of the Colon and Rectum, 45(9), 1139-1153. https://doi.org/10.1007/s10350-004-6381-z

Wong, WD, Congliosi, SM, Spencer, MP, Corman, ML, Tan, P, Opelka, FG, Burnstein, M, Nogueras, JJ, Bailey, HR, Devesa, JM, Fry, RD, Cagir, B, Birnbaum, E, Fleshman, JW, Lawrence, MA, Buie, WD, Heine, J, Edelstein, PS, Gregorcyk, S, Lehur, PA, Michot, F, Phang, PT, Schoetz, DJ, Potenti, F & Tsai, JY 2002, 'The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study', Diseases of the Colon and Rectum, vol. 45, no. 9, pp. 1139-1153. https://doi.org/10.1007/s10350-004-6381-z

@article{207e399a8867431c8924c95107f45fc1,

title = "The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study",

abstract = "PURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon{\texttrademark} artificial bowel sphincter for fecal incontinence. METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1-120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant. RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18-81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.",

keywords = "Artificial bowel sphincter, Fecal incontinence, Multicenter clinical trial, Quality of life",

author = "Wong, {W. Douglas} and Congliosi, {Susan M.} and Spencer, {Michael P.} and Corman, {Marvin L.} and Patrick Tan and Opelka, {Frank G.} and Marcus Burnstein and Nogueras, {Juan J.} and Bailey, {H. Randolph} and Devesa, {Jose Manuel} and Fry, {Robert D.} and Burt Cagir and Elisa Birnbaum and Fleshman, {James W.} and Lawrence, {Mallory A.} and Buie, {W. Donald} and John Heine and Edelstein, {Peter S.} and Sharon Gregorcyk and Lehur, {Paul Antoine} and Francis Michot and Phang, {P. Terry} and Schoetz, {David J.} and Fabio Potenti and Tsai, {Josephine Y.}",

year = "2002",

month = sep,

doi = "10.1007/s10350-004-6381-z",

language = "English (US)",

volume = "45",

pages = "1139--1153",

journal = "Diseases of the Colon and Rectum",

issn = "0012-3706",

publisher = "Lippincott Williams and Wilkins",

number = "9",

}

TY - JOUR

T1 - The safety and efficacy of the artificial bowel sphincter for fecal incontinence

T2 - Results from a multicenter cohort study

AU - Wong, W. Douglas

AU - Congliosi, Susan M.

AU - Spencer, Michael P.

AU - Corman, Marvin L.

AU - Tan, Patrick

AU - Opelka, Frank G.

AU - Burnstein, Marcus

AU - Nogueras, Juan J.

AU - Bailey, H. Randolph

AU - Devesa, Jose Manuel

AU - Fry, Robert D.

AU - Cagir, Burt

AU - Birnbaum, Elisa

AU - Fleshman, James W.

AU - Lawrence, Mallory A.

AU - Buie, W. Donald

AU - Heine, John

AU - Edelstein, Peter S.

AU - Gregorcyk, Sharon

AU - Lehur, Paul Antoine

AU - Michot, Francis

AU - Phang, P. Terry

AU - Schoetz, David J.

AU - Potenti, Fabio

AU - Tsai, Josephine Y.

PY - 2002/9

Y1 - 2002/9

N2 - PURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon™ artificial bowel sphincter for fecal incontinence. METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1-120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant. RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18-81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.

AB - PURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon™ artificial bowel sphincter for fecal incontinence. METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1-120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant. RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18-81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.

KW - Artificial bowel sphincter

KW - Fecal incontinence

KW - Multicenter clinical trial

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=18544363596&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=18544363596&partnerID=8YFLogxK

U2 - 10.1007/s10350-004-6381-z

DO - 10.1007/s10350-004-6381-z

M3 - Article

C2 - 12352228

AN - SCOPUS:18544363596

SN - 0012-3706

VL - 45

SP - 1139

EP - 1153

JO - Diseases of the Colon and Rectum

JF - Diseases of the Colon and Rectum

IS - 9

ER -

The safety and efficacy of the artificial bowel sphincter for fecal incontinence: Results from a multicenter cohort study

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this