Experience with a new prosthetic anal sphincter in three coloproctological centres

Abstract

BackgroundFecal incontinence is a common and severely disabling disorder. For patients with severe fecal incontinence, surgery may prove to be the only adequate treatment option.MethodsThis study reports on 43 patients that were treated with a prosthetic sphincter system between 2005 and 2009 in three coloproctological centres. Main Outcome Measures: complications, anal pressures before and after surgery, fecal continence score.ResultsThe new artificial sphincter system significantly improves continence but leads to some complications in clinical practice. After implantation of the device, continence improved significantly (Keller & Jostarndt continence score 2.6 to 14.3 (P < 0.01)). With the band activated, resting pressure improved significantly as compared to baseline (10.7 mmHg vs. 66.1 mm Hg, P < 0.01). The same holds for anal sphincter squeeze pressure (32.2 mmHg versus 85.9 mm Hg, P < 0.01). Complications occurred in 21 patients (48.8%): 10 surgical and 13 technical. Two patients were affected by both technical and surgical problems. The median time of the occurrence was 3 months postop. In five patients difficulties arose within the first postoperative month leading to explantation of the device in three patients. 90% of complications occurred in the first year.ConclusionsThe soft anal band of AMI (AAS), a new artificial anal sphincter, improves severe anal incontinence, but it must be regarded as a last treatment option to avoid a stoma.

Artificial Muscle Devices: Innovations and Prospects for Fecal Incontinence Treatment

“…® Soft Anal Band, and first reports on the outcome have become available. 15 The preliminary data presented in a conference abstract 45 is supported by a clinical trial with 43 patients. The authors report complication, revision and explantation rates of 48.8, 32.6 and 21.0%, respectively.…”

“…An intraluminal closure pressure of 9 kPa, i.e., 66 mmHg, is reached with 24 mL saline solution. 15 The operation of the system through the skin is still tricky especially for elderly people despite modifications by the manufacturer. 15 The neo-sphincter is implanted through four incisions.…”

“… 15 The operation of the system through the skin is still tricky especially for elderly people despite modifications by the manufacturer. 15 The neo-sphincter is implanted through four incisions. Two perineal incisions are needed to introduce the soft anal band cuff.…”

Design and assessment of novel artificial anal sphincter with adaptive transcutaneous energy transfer system

“…Prostheses with different structures similar to an inflatable circular cuff or an elliptical ring fitted around the anorectal bowel have been developed and studied in both animal experiments and clinical trials. These sphincter prostheses have improved incontinence, but to date they have been associated with many complications and have not gained acceptance [2][3][4][5][6].…”

Micro- and nanostructured electro-active polymer actuators as smart muscles for incontinence treatment

“…Current devices, usually consist of a pump with a liquid-filled inflating cuff, are slow and difficult to operate [2]. They improve incontinence but show considerable complication and revision rates [3].…”