A Prospective, Randomized, Controlled Clinical Trial of Placement of the Artificial Bowel Sphincter (Acticon Neosphincter) for the Control of Fecal Incontinence

Abstract

Through a prospective, randomized trial format, we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone. Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation. For the remainder, the device is easy and discrete to use, highly effective in achieving continence, and able to generate a major improvement in the quality of life.

Challenges faced in the clinical application of artificial anal sphincters

“…These studies focused chiefly on results from the clinical application of the AMS series sphincter (the unmodified AMS800, the modified version of the AMS800, and the final version, the Acticon Neosphincter) from the point of view of safety and efficacy. The longest follow-up period was 10 years after implantation (Christiansen et al, 1999) and the shortest was only 6 months (O'Brien et al, 2004). The largest case included 115 patients (Wong et al, 2002) and the smallest only 6 (Chittawatanarat et al, 2010).…”

“…The clinical application of AAS has been studied by many experts, and this paper summarizes and analyzes the most important 24 studies from 1996 to 2010 (Lehur et al, 1996;2000;Wong et al, 1996;Vaizey et al, 1998;Christiansen et al, 1999;Dodi et al, 2000;Malouf et al, 2000;O'Brien and Skinner, 2000;Altomare et al, 2001;2004;Devesa et al, 2002;Ortiz et al, 2002;Michot et al, 2003;Parker et al, 2003;Romano et al, 2003;Casal et al, 2004;O'Brien et al, 2004;Ruiz Carmona et al, 2009;Gallas et al, 2009;Meurette et al, 2009;Chittawatanarat et al, 2010). These studies focused chiefly on results from the clinical application of the AMS series sphincter (the unmodified AMS800, the modified version of the AMS800, and the final version, the Acticon Neosphincter) from the point of view of safety and efficacy.…”

“…Fifteen papers (Lehur et al, 1998;2000;Christiansen et al, 1999;Malouf et al, 2000;O'Brien and Skinner, 2000;Altomare et al, 2001;2004;Devesa et al, 2002;Wong et al, 2002;Parker et al, 2003;O'Brien et al, 2004;Ruiz Carmona et al, 2009;Gallas et al, 2009;Meurette et al, 2009) reported data about surgical revision, which varied between 13% (Lehur et al, 2002) and 65% (Ruiz Carmona et al, 2009). In three papers of Lehur et al (1998;2000;, the frequencies of surgical revision were 46%, 38%, and 13%, respectively.…”

“…Twelve studies (Wong et al, 1996;Vaizey et al, 1998;O'Brien and Skinner, 2000;Altomare et al, 2001;2004;Lehur et al, 2002;Parker et al, 2003;Romano et al, 2003;O'Brien et al, 2004;Ruiz Carmona et al, 2009;Meurette et al, 2009;Chittawatanarat et al, 2010) assessed the quality of life (QL) and ten of those (Vaizey et al, 1998;O'Brien and Skinner, 2000;Altomare et al, 2001;2004;Lehur et al, 2002;Parker et al, 2003;O'Brien et al, 2004;Ruiz Carmona et al, 2009;Meurette et al, 2009;Chittawatanarat et al, 2010) used one of the following scores: the AMS Quality of Life Scale (AMSQLS), Rockwood FI Quality of Life Score (RFIQLS), Short-Form 36 Questionnaire (SF-36), or the Beck Depression Inventory (BDI) (Wong et al, 1996;Lustman et al, 1997;Lehur et al, 2002;O'Brien et al, 2004;Meurette et al, 2009). The other two studies (Wong et al, 1996;Romano et al, 2003) assessed QL by questionnaire.…”

“…Fifteen papers (Wong et al, 1996;Lehur et al, 1998;2000;Vaizey et al, 1998;Christiansen et al, 1999;Dodi et al, 2000;O'Brien and Skinner, 2000;Altomare et al, 2001;Parker et al, 2003;Romano et al, 2003;Casal et al, 2004;O'Brien et al, 2004;Chittawatanarat et al, 2010) used a fecal incontinence score (FIS) to assess the severity of incontinence of patients. Four scoring systems were adopted: Williams Scale (WS), AMS Fecal Incontinence Score (AMSFIS), Cleveland Continence Score (CCS), and Wexner Continence Grading Score (WCGS) (Jorge and Wexner, 1993;Vaizey et al, 1999;Mundy et al, 2004), as shown in Table 1.…”