AE Bharucha

C Baeten

Cor G. Baeten

DF Altomare

GD Gibel

IG Finlay

J Christiansen

Jarno Melenhorst

JF Johanson

KE Matzel

M Oberwalder

M-JGM Rongen

MA Kamm

MK Baig

NN Baxter

NS Williams

O Belyaev

R Nelson

RL Nelson

Sacha M. Koch

WD Wong

Wim G. van Gemert

English

PubMed

BACKGROUND AND AIMS: Faecal incontinence (FI) is a socially devastating problem. The treatment algorithm depends on the aetiology of the problem. Large anal sphincter defects can be treated by sphincter replacement procedures: the dynamic graciloplasty and the artificial bowel sphincter (ABS). MATERIALS AND METHODS: Patients were included between 1997 and 2006. A full preoperative workup was mandatory for all patients. During the follow-up, the Williams incontinence score was used to classify the symptoms, and anal manometry was performed. RESULTS: Thirty-four patients (25 women) were included, of which, 33 patients received an ABS. The mean follow-up was 17.4 (0.8-106.3) months. The Williams score improved significantly after placement of the ABS (p &lt; 0.0001). The postoperative anal resting pressure with an empty cuff was not altered (p = 0.89). The postoperative ABS pressure was significantly higher then the baseline squeeze pressure (p = 0.003). Seven patients had an infection necessitating explantation. One patient was successfully reimplanted. CONCLUSION: The artificial bowel sphincter is an effective treatment for FI in patients with a large anal sphincter defect. Infectious complications are the largest threat necessitating explantation of the device

Melenhorst, J.

Koch, S.M.

van Gemert, W.

Baeten, C.G.

Maastricht University Research Portal

The artificial bowel sphincter for faecal incontinence: a single centre study.

Springer - Publisher Connector

ORIGINAL ARTICLE
The artificial bowel sphincter for faecal incontinence:
a single centre study
Jarno Melenhorst & Sacha M. Koch &
Wim G. van Gemert & Cor G. Baeten
Accepted: 20 June 2007 / Published online: 10 October 2007
# Springer-Verlag 2007
Abstract
Background and aims Faecal incontinence (FI) is a socially
devastating problem. The treatment algorithm depends on
the aetiology of the problem. Large anal sphincter defects
can be treated by sphincter replacement procedures: the
dynamic graciloplasty and the artificial bowel sphincter
(ABS).
Materials and methods Patients were included between
1997 and 2006. A full preoperative workup was mandatory
for all patients. During the follow-up, the Williams
incontinence score was used to classify the symptoms,
and anal manometry was performed.
Results Thirty-four patients (25 women) were included, of
which, 33 patients received an ABS. The mean follow-up
was 17.4 (0.8–106.3) months. The Williams score improved
significantly after placement of the ABS (p<0.0001). The
postoperative anal resting pressure with an empty cuff was
not altered (p=0.89). The postoperative ABS pressure was
significantly higher then the baseline squeeze pressure
(p=0.003). Seven patients had an infection necessitating
explantation. One patient was successfully reimplanted.
Conclusion The artificial bowel sphincter is an effective
treatment for FI in patients with a large anal sphincter
defect. Infectious complications are the largest threat
necessitating explantation of the device.
Keywords Artificial bowel sphincter . Single centre .
Faecal incontinence
Introduction
Faecal incontinence (FI) is a complex problem. The
resulting social isolation is a major concern, which results
in a reduced quality of life [1]. The real prevalence is
unknown, but studies show a higher prevalence than
expected [2–5]. Most patients are females with one or
more vaginal deliveries in the past. Direct trauma to the
anal sphincter complex can give immediate problems or
problems later in life [6, 7].
The initial therapy should be conservative, e.g. diet
modifications, medication, biofeedback physiotherapy or
retrograde irrigation. Surgical intervention is indicated
when conservative treatment fails. An anal repair is usually
the first choice of treatment for a minor sphincter defect.
Satisfactory results are achieved in a tension-free repair in
47–100% of the cases [8]. Long-term results are less
satisfying [9]. Sacral nerve modulation (SNM) has proven
to be effective for treating faecal incontinence in patients
with an intact sphincter complex [10]. Sphincter replacing
therapy is indicated in patients with large sphincter defects
or completely disrupted sphincters and in case of SNM
failure. The sphincter replacement procedures are grossly
divided in the dynamic graciloplasty (DGP) [11, 12] or the
artificial bowel sphincter (ABS). The first artificial bowel
sphincter for faecal incontinence was a urinary prosthesis
(AMS 800, AMS) placed by Christiansen in 1987 [13].
Modifications had to be made to suit the anal sphincter for
use in patients with faecal incontinence.
Until 1997, patients with faecal incontinence due to large
anal sphincter defects were treated with DGP in our
Int J Colorectal Dis (2008) 23:107–111
DOI 10.1007/s00384-007-0357-0
J. Melenhorst :W. G. van Gemert : C. G. Baeten (*)
Department of Surgery, University Hospital Maastricht,
P. Debyelaan 25, Postbus 5800,
6202 AZ Maastricht, The Netherlands
e-mail: c.baeten@surgery.azm.nl
S. M. Koch
Department of Surgery, VieCuri Medical Center,
Tegelseweg 210,
5912 BL Venlo, The Netherlands
institution [16]. Since then, the ABS was introduced in our
institution for the same indication. Because the operating
technique is similar, there was no learning curve to be dealt
with. Is this study, the results of the ABS implantations for
the treatment of feacal incontinence in a large volume
centre are presented.
Materials and methods
This study is a non-randomised, non-controlled, prospective
single-centre study. Thirty-four patients with persisting or
recurrent end-stage FI were included between 1997 and
2006.The majority of patients had large (>33% of circum-
ference) anal sphincter defects. A sufficient length of the
perineum was a prerequisite for ABS implantation. Previous
sphincter replacement surgery was no exclusion criterion for
implantation of an ABS. All patients underwent a full
preoperative examination consisting of a defaecography,
endo-anal ultrasound (SDD 2000, Multiview, Aloka, Japan,
7,5 Mhz endo-anal transducer), pudendal nerve terminal
motor latency measurement (St Mark’s pudendal electrode)
and anal manometry using a Konigsberg catheter (Konigsberg
Instrument, Pasadena CA, USA) connected to a polygraph
(Synectics Medical, Stockholm, Sweden). An Acticon artifi-
cial bowel sphincter (ABS, American Medical Systems,
Minneapolis, MN, USA) was used in all patients. The
Williams incontinence score was used to classify the
symptoms. Anal manometry was routinely performed during
the follow-up and used to objectivity ABS function. The
follow-up appointments were scheduled at 1, 3, 6, 12 months
and annually. Infection necessitating explantation was
Table 1 Aetiology and previous surgical treatment
Number Sex Etiology Previous treatment
1 F Hysterectomy, cervix carcinoma, radiotherapy
2 M Anal atresia DGP
3 F Two breech deliveries: rupture Anal repair, SNM
4 F Episiotomy, hysterectomy PNE
5 M Pelvic trauma: urethra/rectum rupture Repair and colostomy
6 M Trauma, partial spinal cord lesion PNE
7 F Delivery trauma: total rupture, hysterectomy Anal repair, SNM
8 F Delivery trauma: rupture
9 M Anal atresia
10 M Classical hemorroidectomy
11 F Episiotomy, hysterectomy PNE
12 F Delivery trauma: rupture Two anal repairs, PNE
13 F Delivery trauma: total rupture Two anal repairs,
14 F Delivery trauma: rupture Anal repair
15 F Delivery trauma: rupture, cauda syndrome Anal repair
16 F Delivery trauma: rupture, hysterectomy Anal repair
17 F Delivery trauma: rupture, hysterectomy Anal repair
18 M Anal atresia DGP
19 F Delivery trauma: rupture Anal repair
20 F Delivery trauma: rupture Pre-/post-anal repair, PNE
21 F Delivery trauma: rupture, hysterectomy Anal repair, PNE
22 F Delivery trauma: rupture Post-anal repair, SNM
22 M Low anterior resection T2NOM0
23 F Delivery trauma: rupture
24 M Pelvic crush trauma: urethra/rectum rupture Repair and colostomy
25 F Delivery trauma: rupture
26 F Delivery trauma: total rupture 12 anal repairs
27 F Delivery trauma: rupture Anal repair, colostomy
28 F Delivery trauma: rupture Anal repair
29 M Pelvic trauma
30 F Delivery trauma, uterus extirpatie DGP
31 F Delivery trauma PNE
32 F Classical hemorroidectomy SECCA
33 F Delivery trauma, total rupture Anal repair, Thiersch wire
34 F Delivery trauma, hysterectomy PNE
F Female, M male, DGP dynamic graciloplasty, SNM sacral neuromodulation, PNE percutaneous nerve evaluation
108 Int J Colorectal Dis (2008) 23:107–111
a primary endpoint. A re-intervention was a secondary
endpoint.
The system implantation has been described extensively
elsewhere [14, 15], but will be summarised here. The ABS
implant consists of three parts: an inflatable balloon, a cuff
and a pump. Under strict systemic and local antibiotic
prophylaxes, the cuff is placed around the anus using two
lateral incisions. The pump is placed in the labia majora or
scrotum, and the pressure-regulating balloon is placed in
cavum Retzii. Care is taken not to perforate the rectum. If a
perforation occurs, the procedure is stopped. After proper
wound healing, the patient is eligible for another implan-
tation procedure.
Data are expressed as the mean with the range between
parenthesis. Data were analysed using the commercially
available GraphPad Prism 4.00 software (GraphPad
Software, San Diego, USA). The Wilcoxon signed rank
test was used for non-parametric paired values. Statistical
significance was set at p<0.05.
Results
The patient population existed of 25 women and nine men.
The aetiology of the faecal incontinence is shown in
Table 1. Three patients were previously treated with a
DGP. The average age was 55.3 (23.8–75.6) years. The
mean period of faecal incontinence before the placement
of the ABS was 11.0 (1.0–48.0) years. One patient had a
rectum perforation during the initial surgery, and place-
ment of the ABS was abandoned. She awaits a second
implant attempt. Thirty-three patients were implanted. The
mean follow-up was 17.4 (0.8–106.3) months. The mean
procedure time was 68.1 min (38.0–105.0). In 24 patients,
the length of the cuff was 11 cm, in three patients 10 cm,
in two patients 13 cm, in two patients 12 cm, in one
patient 14 and in one patient 9. The width of the cuff was
in all, but one patient, 2.9 cm. There was one patient with
a cuff off 2.0 cm. All patients received a pressure-
regulating balloon of 91–100 cm H2O. The mean
postoperative hospital stay was 3.5 (2.0–12.0) days.
The mean preoperative Williams score of 4.8 (4–5)
decreased significantly after ABS placement to 2.1 (1–5;
Fig. 1). The mean preoperative anal resting pressure was
58.1 (17.0–128.0) mmHg. This was not significantly
altered after implantation (60.3 (21.0–93.0 mmHg; p=
0.89). The mean preoperative squeeze pressure was 80.1
Pre-operative Post-operative
0
1
2
3
4
5
6 p<0.0001
W
il
li
am
s 
sc
o
re
Fig. 1 Mean pre- and postoperative Williams score (1 = continent,
2 = incontinent to flatus, 3 = incontinent to liquid stool, 4 = occasional
incontinence to normal stool <1, 5 = fully incontinent)
Fig. 2 Baseline resting pressure versus deflated ABS pressure and
baseline squeeze pressure vs inflated ABS pressure pre- and
postoperatively (at last follow-up)
34 patients 
33 implants 1 intraoperative 
rectum perforation 
8 explantations 
1 successful 
reimplantation 
7 infections 
26 patients available 
for FU 
1 case of persisting 
peri-anal pain 
Fig. 3 Flow chart of implanted patients
Int J Colorectal Dis (2008) 23:107–111 109
(25.0–149.0) mmHg, which increased to 120.5 (65.0–
154.0) mmHg after implantation (p=0.003; Fig. 2).
Thirteen patients (39%) complained about a rectal
evacuation problem. In 12 patients, this could be managed
conservatively. One patient had a revision of the system
with placement of a wider anal cuff. Seven patients (21.2%)
had an infection of the system, which led to seven
explantations. One of these patients has been implanted
successfully with a new ABS (Fig. 3).
In one patient, the ABS was successfully converted to a
dynamic graciloplasty. In two patients, a colostomy was
performed. The other three patients had no other interventions.
One patient was explanted due to persisting peri-anal
pain without an infection. She received a colostomy.
Twenty-six reinterventions (including explantations) had
to be performed. This means 0.79 re-intervention per
implanted patient.
Discussion
There is a large experience in our institution with the DGP
[16]. However, since 1997, the ABS is also performed in
our institution for the same area of indications as the DGP.
When a patient qualifies for a sphincter replacement
procedure, he or she can decide whether an ABS or DGP
will be performed. Nonetheless, sufficient perineal length is
a prerequisite for ABS implantation in a female patient. We
believe that the risk for late erosion of the ABS is higher in
the case of severe, cloaca-like malformations of the
perineum. In these cases, a DGP is the preferred procedure.
All patients in this study had an adequate perineal length.
In the beginning, the initial infection rate of the DGP
was a problem, but improved as a result of technical
modifications and the introduction of systemic and local
antibiotic prophylaxis. The same prophylaxis protocol was
used for the implantation of ABS. However, despite
meticulous application of the antimicrobial protocol, the
infection rate of the ABS implantations in our patient
population remains high and is comparable with other
series [14, 15]. We believe that this infection rate is likely to
remain a serious problem in every attempt to place a corpus
alienum around the anus through peri-anal incisions.
To overcome this problem of infection, Finlay et al. [17]
have developed a new prosthetic sphincter, which is placed
above the pelvic floor musculature by means of a
laparotomy. It was hypothesised that this sphincter will
function as a new puborectal sling in this position. Till now,
12 patients are implanted. Infectious complications, how-
ever, occurred in three patients (25%), with subsequent
removal of the system. Technical problems occurred in five
of the nine remaining patients during follow-up. Technical
failure is also one of the main problems of the ABS. Twelve
of our patients had some sort of technical failure. This is
also known from other studies concerning the ABS [18].
Only limited data on long-term follow-up of a sufficient
number of ABS sphincters are available. There is one
multicentre study with disappointing long-term data where
the initial data were promising [19]. The anal manometry
data of this patient population suggest poor action of the
ABS. The authors conclude that the ABS acts as a passive
barrier causing a rectal outlet obstruction. Our manometry
data contradict with this conclusion. We strongly believe
that the ABS acts as an active sphincter. In our experience,
the patients need to deflate the anal cuff to defecate.
Nevertheless, constipation can be a problem. Thirteen of
our patients complained about constipation. This could be
solved in the majority of patients by conservative means.
One patient needed a wider anal cuff to treat an outlet
obstruction.
The indications for sphincter replacement surgery are
decreasing in our institution since the introduction of SNM.
The relative numbers of DGPs and ABSs decreased, while
the number of SNM has increased. This implicates that ABS
and DGP are reserved for the more severe complicated cases
of faecal incontinence. A higher complication rate is
therefore expected. However, the placement of an ABS
remains an alternative to a colostomy in the well-informed
and motivated patient even if a DGP has failed.
Conclusion
The artificial bowel sphincter is an effective treatment
option for severe faecal incontinence. Even in experienced
hands, the risk of infection, explantation and system
malfunctioning remain high. In well-informed and motivat-
ed patients, it is worthwhile to proceed to implantation, as
the alternative is a colostomy. Our data suggest that the
ABS acts as an active sphincter and not as a passive barrier.
References
1. Bharucha AE, Zinsmeister AR, Locke GR, Schleck C, McKeon
K, Melton LJ (2006) Symptoms and quality of life in community
women with fecal incontinence. Clin Gastroenterol Hepatol
4:1004–1009
2. Gibel GD, Lefering R, Troidl H, Bloch H (1998) Prevalence of
fecal incontinence: what can be expected? Int J Colorectal Dis
13:73–77
3. Johanson JF, Lafferty J (1996) Epidemiology of fecal inconti-
nence: the silent affliction. Am J Gastroenterol 91:33–36
4. Nelson R, Norton N, Cautley E, Furner S (1995) Community-
based prevalence of anal incontinence. JAMA 274:559–561
5. Nelson RL (2004) Epidemiology of fecal incontinence.
Gastroenterology 126:S3–S7 (Jan)
110 Int J Colorectal Dis (2008) 23:107–111
6. Oberwalder M, Dinnewitzer A, Khurrum B, Thlaer K, Cotman K,
Nogueras J et al (2004) The association between late-onset fecal
incontinence and obstetric anal sphincter defects. Arch Surg
139:429–432
7. Kamm MA (1994) Obstetric damage and fecal incontinence.
Lancet 334:730–733
8. Baig MK, Wexner SD (2000) Factors predictive of outcome after
surgery for faecal incontinence. Br J Surg 87:1316–1330
9. Baxter NN, Bravo Guittierez A, Lowry AC, Parker SC, Madoff
RD (2003) Long-term results of sphincteroplasty for acquired
faecal incontinence. Dis Colon Rectum 46:A21–A22
10. Matzel KE, Kamm MA, Stösser M, Baeten CGMI, Christiansen J,
Madoff R, Mellgren A et al (2004) Sacral nerve stimulation for
feacal incontinence: multicenter study. Lancet 363:1270–1276
11. Williams NS, Patel J, George BD, Halan RI, Watkins ES (1991)
Development of an electrically stimulated neoanal sphincter.
Lancet 338:1166–1169
12. Baeten C, Spaans F, Fluks A (1988) An implanted neuromuscular
stimulator for fecal continence following previously implanted
gracilis muscle. Report of a case. Dis Colon Rectum 31:134–137
13. Christiansen J, Lorentzen M (1987) Implantation of artificial
sphincter for anal incontinence. Lancet 2:244–245
14. Wong WD, Congliosi SM, Spencer MP, Corman ML, Tan P,
Opelka FG et al (2002) The safety and efficacy of the artificial
bowel sphincter for fecal incontinence: results from a multicenter
cohort study. Dis Colon Rectum 45:1139–1153
15. Altomare DF, Dodi G, La Torre F, Romano G, Melega E, Rinaldi M
(2001) Multicentre retrospective analysis of the outcome of artificial
anal sphincter implantation for severe faecal incontinence. Br J Surg
88:1481–1486
16. Rongen M-JGM, Uludag Ö, El Naggar K, Geerdes BP, Konsten
J, Baeten CGMI (2003) Long-term follow-up of dynamic
graciloplasty for fecal incontinence. Dis Colon Rectum
46:716–721
17. Finlay IG, Richardson W, Hajivassiliou CA (2004) Outcome after
implantation of a novel prosthetic anal sphincter. Br J Surg
91:1485–1492
18. Belyaev O, Muller C, Uhl W (2006) Neosphincter surgery for
fecal incontinence: a critical and unbiased review of the relevant
literature. Surg Today 36:295–303
19. Altomare DF, Binda GA, Dodi G, La Torre F, Romano G, Rinaldi
M, Melega E (2004) Disappointing long-term results of the
artificial bowel sphincter for faecal incontinence. Br J Surg
91:1352–1353
Int J Colorectal Dis (2008) 23:107–111 111


The artificial bowel sphincter for faecal incontinence: a single centre study

BACKGROUND AND AIMS: Faecal incontinence (FI) is a socially devastating problem. The treatment algorithm depends on the aetiology of the problem. Large anal sphincter defects can be treated by sphincter replacement procedures: the dynamic graciloplasty and the artificial bowel sphincter (ABS). MATERIALS AND METHODS: Patients were included between 1997 and 2006. A full preoperative workup was mandatory for all patients. During the follow-up, the Williams incontinence score was used to classify the symptoms, and anal manometry was performed. RESULTS: Thirty-four patients (25 women) were included, of which, 33 patients received an ABS. The mean follow-up was 17.4 (0.8-106.3) months. The Williams score improved significantly after placement of the ABS (p < 0.0001). The postoperative anal resting pressure with an empty cuff was not altered (p = 0.89). The postoperative ABS pressure was significantly higher then the baseline squeeze pressure (p = 0.003). Seven patients had an infection necessitating explantation. One patient was successfully reimplanted. CONCLUSION: The artificial bowel sphincter is an effective treatment for FI in patients with a large anal sphincter defect. Infectious complications are the largest threat necessitating explantation of the device

NARCIS 

Crossref

The artificial bowel sphincter for faecal incontinence: a single centre study

Abstract

Similar works

Full text

Available Versions

Maastricht University Research Portal

Springer - Publisher Connector

NARCIS

Springer - Publisher Connector

Maastricht University Research Portal

Crossref