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Chapter 21 The Artificial Bowel Sphincter in the Treatment
21.6.3 New Indications for Acticon ABS
Indications for use of the Acticon ABS are also broadening and have reached the complex field of anorectal reconstruction following abdominoperineal excision. Romano
et al. (2003) reported the use of the Acticon ABS in this setting. In a series of eight patients, implantation of Acticon ABS was done at the same time as rectal excision (one
case), differed 2 months (five cases), and many years later (two cases).No explantation
has been given to date. Among the five patients with an activated device, four are reported to have a good neoanal function. Our personal experience is based on three female patients in whom a Acticon ABS was implanted around a perineal colostomy
built after curative rectal excision for T2 cancer (Lehur et al.2003). Two of them have
had preoperative radiotherapy. Implantation was done a mean 3 years after cancer
treatment.At a mean 2 years of follow-up,the three patients had an activated and functional Acticon ABS. Tolerance at 2 years was satisfactory.Continence and quality of life
significantly improved. The three patients considered to be improved by the implantation even though they were still on retrograde colonic enemas.
In this limited experience, implantation of an artificial sphincter around a perineal
colostomy following rectal excision for cancer appeared feasible and safe, even in case
of previous radiotherapy.
21.7 Indications and Contraindications
Many factors, both anal and extra-anal, contribute to fecal continence. It is apparent
that the achievement of the artificial anal sphincter is to restore a high-pressure zone
in the anal canal, in a static manner with no ability to increase pressure in the event of
a threat to continence. The artificial anal sphincter corrects the loss of resting anal
pressure.It would thus be fallacious to assume that normal continence can be restored
by this means,even though the functional results obtained are highly satisfactory.
The best indications for the artificial anal sphincter are lesions of the anal sphincters inaccessible to local repair (Table 21.4). The good results in this context are that the
result of other extra-anal sphincter mechanisms being preserved. Thus, the artificial
sphincter may be recommended, particularly in young subjects, when the chances for
successful local repair are poor.
In cases of incontinence resulting from sequelae of anal agenesis, there is a lower
chance of success. The lack of anal sensitivity and a rectal reservoir and the existence
of associated colonic motor disorders make all techniques of sphincteric substitution
307
Table 21.4. Indications and contraindications for the Acticon ABS artificial bowel sphincter
Good indications Relative indications Contraindications
Traumatic sphincter disruption Anal imperforation Excessive perineal descent
Neurologic incontinence Severely scarred perineum Severe constipation
Neurogenic (idiopathic) Thin rectovaginal wall Irradiated perineum
incontinence Advanced age ?? Perineal sepsis
Diabetes ?? Crohn’s disease
Handling difficulties Anal coitus
21
308
Guillaume Meurette,Paul-Antoine Lehur
more uncertain. There are no available data predictive of the success of the Acticon
ABS in this indication, and some patients seem to have obtained better functional results with techniques of anterograde colonic enemas.
In cases of neurogenic or neurologic fecal incontinence, it is essential to take into
account possible associated dyschezia and excessive perineal descent. The artificial
anal sphincter creates an obstacle to rectal evacuation, which can sometimes cause
considerable evacuation difficulties. The restoration of continence should not be
achieved to the detriment of evacuation capacities. However, an objective assessment
of the state of preoperative transit is not always easy. Patients have often modified their
diet to avoid difficulties or have had recourse to antidiarrheic treatments. Rectal prolapse or a history of surgical cure for prolapse should be carefully considered before
implantation of an artificial sphincter,insofar as these conditions are indicative of disturbances in the evacuation process.
The contraindications to implantation of an artificial sphincter are more apparent
(Table 21.4). Although the role of the artificial anal sphincter in anoperineal reconstructions after amputation of the rectum has not yet been defined, radiation therapy
will probably be a limiting factor.The implantation of an Acticon ABS is possible after
failure of graciloplasty and has already been reported. Likewise, reimplantation of the
device can take place immediately after explantation when all or part of the device has
to be replaced because of a mechanical failure,or later,in the event of an infection, after all inflammatory processes have disappeared.
The artificial anal sphincter is suitable for well-motivated,selected patients with fecal incontinence of more than a year’s duration, whose condition is regarded as an important personal, familial, and/or social handicap. The technique should be proposed
to the patient as an alternative to definitive colostomy. A capability to manipulate the
control pump is required as well as sufficient intellectual capacity to understand the
functioning of the device and ensure regular rectal evacuation. The success of this innovative technique depends on serious consideration of these selection criteria.
21.8 Conclusion
To conclude, the role of the Acticon ABS artificial sphincter has to be put in perspective regarding the other new minimally invasive approaches of anal incontinence,
namely in our experience, sacral nerve stimulation.Although morbidity and the need
for revision surgery is high following implantation of the Acticon ABS, outcome in
terms of continence and improvement of quality of life is significantly satisfactory. Selection of patients is mandatory to achieve best results. Late mechanical failure is a
concern and requires adaptation from the AMS company and continuous evaluation
from involved surgeons.
In case of non-response to conservative treatment,local repair or sacral nerve stimulation, the Acticon ABS artificial sphincter is an effective solution for motivated patients and experienced surgeons
References
Altomare DF, Dodi G, La Torre F, Romano G, Melega E,Rinaldi M (2001) Multicentre retrospec-
tive analysis of the outcome of artificial anal sphincter implantation for severe faecal incon-
tinence. Br J Surg 88 : 1481–1486
Chapter 21 The Artificial Bowel Sphincter in the Treatment
Christiansen J, Lorentzen M (1987) Implantation of artificial sphincter for anal incontinence.
Lancet 1: 244–245
Hajivassiliou CA, Carter KB, Finlay IG (1997) Assessment of a novel implantable artificial anal
sphincter.Dis Colon Rectum 40 : 711–717
Lehur PA, Michot F, Denis P, Grise P, Leborgne J,Teniere P,Buzelin JM (1996) Results of artificial
sphincter in severe anal incontinence. Report of 14 consecutive implantations.Dis Colon Rec-
tum 39: 1352–1355
Lehur PA, Zerbib F, Glemain P, Neunlist M,Bruley S (2002) Comparison of quality of life and an-
orectal function after artificial sphincter implantation. Dis Colon Rectum 45:508–513
Lehur PA, Doucet C, Lasser P, Lechaux D (2003) Secondary implantation of an artificial anal
sphincter after abdomino-perineal excision and perineal colostomy for rectal cancer. Color-
ect Dis 5 : 108
Michot F, Costaglioli B, Leroi AM, Denis P (2003) Artificial anal sphincter in severe fecal inconti-
nence: outcome of prospective experience with 37 patients in one institution. Ann Surg 237:
52–56
O’Brien PE, Dixon JB, Skinner S,Laurie C, Khera A, Fonda D (2004) A prospective randomised
controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphicter)
for the control of fecal incontinence. Dis Colon Rectum (in press)
Ortiz H, Armendariz P, DeMiguel M, Ruiz MD, Amos R,Roig JV (2002) Complications and func-
tional outcome following artificial anal sphincter implantation.Br J Surg 89: 877–881
Parker SC, Spencer MP, Madoff RD, Jensen LL, Wong WD, Rothenberger DA (2003). Artificial
bowel sphincter: long-term experience at a single institution. Dis Colon Rectum 46 :722–729
Romano G, La Torre F, Cutini G, Bianco F, Esposito P, Montori A (2003) Total anorectal recon-
struction with the artificial bowel sphincter: report of eight cases. Dis Colon Rectum 46:
730–734
Savoye G, Leroi AM, Denis P, Michot F (2000) Manometric assessment of an artificial bowel
sphincter.Br J Surg 87: 586–589
Wong WD, Congilosi S, Spencer M, Corman ML, Tan P, Opelka FG, Burnstein MJ, Nogeuras JJ,
Bailey HR, Devesa JM, Fry RD, Cagir B, Birnbaum E, Fleshman JW, Lawrence MA, Buie WD,
Heine J,Edelstein PS,Gregorsky S, Lehur PA, Michot F, Phang PT, Schoetz DJ, Potenti F, Tsai JY
(2002) The safety and efficacy of the artificial bowel sphincter for faecal incontinence: results
from a multicenter cohort study.Dis Colon Rectum 45 : 1139–1153
309
Chapter 22
Chapter 22 Innovations in Fecal Incontinence: Sacral Nerve
Innovations in Fecal Incontinence:
Sacral Nerve Stimulation
Klaus E. Matzel,Uwe Stadelmaier,Werner Hohenberger
311
22
Contents
22.1 Methods and Patient Selection . . . . . . . . . . . . . . . 312
22.1.1 Technique . . . . . . . . . . . . . . . . . . . . . . . . . . 312
22.1.1.1 Acute Percutaneous Nerve Evaluation . . . . . . . . . . 312
22.1.1.2 Subchronic Percutaneous Nerve Evaluation . . . . . . . 312
22.1.1.3 Chronic Stimulation with a Permanent Implant . . . . . 313
22.2 Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . 314
22.2.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . 314
22.2.2 Contraindications . . . . . . . . . . . . . . . . . . . . . . 314
22.2.3 Selection Process . . . . . . . . . . . . . . . . . . . . . . 315
22.3 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 317
22.3.1 Clinical Results . . . . . . . . . . . . . . . . . . . . . . . 317
22.3.2 Quality of Life . . . . . . . . . . . . . . . . . . . . . . . . 319
22.3.3 Anorectal Physiologic Findings . . . . . . . . . . . . . . 319
22.4 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . 319
References . . . . . . . . . . . . . . . . . . . . . . . . . . 322
22
312
Klaus E. Matzel,Uwe Stadelmaier,Werner Hohenberger
22.1 Methods and Patient Selection
22.1.1 Technique
The technique for SNS consists of two diagnostic stages, followed by a third therapeutic stage. As it has been well described previously (Schmidt et al. 1990; Matzel et al.
1995a; Hohenfellner et al.1997), the following will outline the procedure and highlight
recent technical developments.
22.1.1.1 Acute Percutaneous Nerve Evaluation
Acute percutaneous nerve evaluation (PNE) aims to determine whether, in the prospective patient,contraction of the striated pelvic floor muscles can be elicited by sacral
nerve stimulation (SNS) (thus establishing the integrity of the sacral spinal nerves)
and to test the individual relevance of each sacral spinal nerve to anal sphincteric contraction (Matzel 2001) and anal canal closure (thus identifying the optimal site of
stimulation). The procedure can be performed under general or local anesthesia.
For acute PNE,needle electrodes (Model 041828 or 041829 Foramen Needles,Medtronic, Minneapolis, MN, USA) are inserted into the dorsal sacral foramina of S2, S3
and S4. This positioning aims for placement close to the site where the sacral spinal
nerves enter the pelvic cavity through the ventral opening of the sacral foramen and
proximal to the sacral plexus (Matzel et al. 1990).
For correct placement,palpable anatomic landmarks are helpful in identifying the
sacral foramina; intermittent stimulation with graduated amplitudes and visual confirmation of the motor response of the pelvic floor and anus will optimize the position
of the needle electrode. Although the effect of stimulation on pelvic floor and lower
extremity activity may vary among individuals,the following responses are generally
typical: S2 stimulation results in a clamp-like contraction of the perineal muscles and
an outward rotation of the leg; S3 stimulation leads to contraction of the levator ani
and external anal sphincter, resulting in a bellows-like movement, along with plantar
flexion of the first and second toes; S4 stimulation produces a strong, bellows-like contraction of the levator ani without movement of leg, foot or toe (Schmidt et al. 1990).
If this acute stimulation successfully elicits contraction of the pelvic floor, subchronic percutaneous stimulation is initiated to evaluate the therapeutic potential of
low-frequency stimulation of the identified nerve(s).
22.1.1.2 Subchronic Percutaneous Nerve Evaluation
The sacral spinal nerve(s), found in acute testing to be most effective with regard to
muscular contraction and anal canal closure pressure (most commonly, but not consistently, S3), is/are stimulated continuously for a period of time sufficient to demonstrate a potential effect on fecal incontinence. Thus, the observation period depends
on the frequency of incontinent episodes: bowel habits, such as frequency and degree
of involuntary loss of stool, are documented with standardized bowel diaries.
Two technical options are used for subchronic PNE: a temporary, percutaneously
placed, test stimulation lead (or multiple leads) (Model 041830,Temporary Screening
Lead, Minneapolis, MN, USA) that will be removed at the end of this phase; or opera-
Chapter 22 Innovations in Fecal Incontinence: Sacral Nerve Stimulation
tive placement of a quadripolar lead, the so-called foramen electrode (Model 3886,
Medtronic, Minneapolis, MN, USA). Both types of leads are connected to an external
pulse generator for screening (Screener 3625, Medtronic), the latter with a percutaneous extension cable (Janknegt et al. 1996).
Percutaneous placement of temporary test stimulation leads can be done on just
one sacral spinal nerve or on multiple spinal nerves to offer the option of testing the
effect of stimulation of different sides and levels or of synchronous stimulation of
multiple nerves in an awake patient (Stadelmaier et al. 2001).The operative placement
of foramen electrodes is usually limited to one site.
With both techniques, the selected sacral spinal nerve is continuously stimulated
(pulse width, 210 µs; frequency, 15 Hz), except during voiding and defecation. The amplitude of stimulation may require adjustment, depending on position,tissue reaction
or electrode movement,and is adaptable by the patient within a limited range (1–10 V)
according to his or her perception of muscle contraction or perianal sensation.
At the end of the screening phase,the percutaneously placed temporary test stimulation lead is removed; the operatively placed foramen electrode is either removed (if
unsuccessful) or connected to an implanted pulse generator (so-called two-stage implant; Janknegt et al.1996), offering the advantage of identical positioning of the electrode during screening and therapeutic stimulation.
22.1.1.3 Chronic Stimulation with a Permanent Implant
Permanent stimulation with a fully implantable device aims to make use of the therapeutic effect achieved by subchronic PNE. Patients with a temporary test stimulation
lead undergo simultaneous operative implantation of the quadripolar foramen lead
and the pulse generator (Model Itrel II/X-Trel, 7495,Extension kit, Model 3023 INTERSTIM implantable pulse generator, Medtronic, Minneapolis, MN, USA); those with a
foramen electrode already in place undergo removal of the percutaneous extension
before placement of the pulse generator subcutaneously in the abdomen (Hohenfellner et al. 1997) or gluteal area (Scheepens et al.2001).
Recently, a less invasive technique that uses a foramen electrode with a modified
anchoring device placed through a trocar (Model 3550–18, Medtronic, Minneapolis,
MN, USA) has been proposed (Spinelli et al. 2003). This technique can be used either
for stage one of the two-stage implant or for electrode placement after successful
screening with wire electrodes.
The foramen electrode contains four contact electrodes. The electrode combination
most effective with regard to required voltage and the patient’s perception of muscle
contraction of the perineum and anal sphincter is chosen for permanent stimulation.
The parameters used (see subchronic PNE,above) are those found to be clinically effective and to cause no damage to the nerve: pulse width, 210 µs; frequency, 15 Hz;
on/off: 5–1 s or continuous stimulation; level of stimulation usually above individual
patient’s perception of muscular contraction and adjusted if necessary (Schmidt
1988). The pulse generator is activated by telemetry (Model 7432 Console Programmer,
Medtronic, Kerkrade, The Netherlands). Patients are instructed to interrupt stimulation with a hand-held programmer (Model 3031, Minneapolis,MN, USA) only for defecation and urinary voiding.
In a different operative approach in patients in whom problems are encountered
during foramen electrode placement, the sacral spinal nerves are exposed within the
sacral canal by a small dorsal laminectomy of the sacrum, and cuff electrodes (Med-
313
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Klaus E. Matzel,Uwe Stadelmaier,Werner Hohenberger
tronic) with symmetrically arranged contacts are positioned and fixed bilaterally
around the sacral spinal nerve (Matzel et al.2001).
22.2 Patients
22
Published reports differ with regard to the patient population,representing the evolution of indications.
22.2.1 Indications
As the purpose of SNS is to recruit residual function of the continence organ by
electrical stimulation of its peripheral nerve supply, indications were initially confined
to patients with deficient striated anal sphincter and levator ani function, but with no
gross morphologic defect (determined by ultrasound or MRI) (Matzel et al. 1995b).
Thus, the initial patient selection for the SNS protocol was based on the clinical and
physiologic finding of reduced or absent voluntary sphincteric function (confirmed by
anorectal manometry), but existing reflex activity (confirmed by intact anocutaneous
reflex activity or by muscular response to pudendal stimulation with the St. Mark’s
electrode – the measurement of pudendal nerve terminal motor latency is of no predictive value; Matzel et al. 2004),indicating an intact nerve–muscle connection.In this
group of patients the causes varied, covering a spectrum from postoperative sphincteric weakness consequent to anal and rectal procedures to total lack of voluntary
sphincteric control as a sequela of cauda syndrome secondary to lumbar spine fracture. The latter suggested the potential use of SNS in neurogenic incontinence (Matzel
2001) (Table 22.1).
With the help of PNE and based on physiologic findings during temporary test
stimulation (suggesting that the effect of SNS is not limited to the striated sphincter
muscle) (Vaizey et al. 1999), the indications for permanent SNS were expanded to patients suffering from fecal incontinence owing to a deficiency of the smooth-muscle
internal anal sphincter, to limited structural defects, and to functional deficits of the
external and internal sphincter. Among these patients the causes vary widely (Table 22.1).
Subsequently a more pragmatic approach evolved.Further studies based the indication for test stimulation on the existence of an anal sphincter and residual sphincteric or reflex function – regardless of the underlying physiologic condition. The therapeutic benefit of SNS was subsequently outlined in patients with fecal incontinence
owing to reduced striated muscle function from various causes with concomitant urinary incontinence (Leroi et al. 2001) and in a spectrum of neurogenic causes (Rosen et
al. 2001) (Table 22.1). Reports focusing on specific etiologies usually represent a welldefined subset of larger patient cohorts (Kenefick et al.2002c).
22.2.2 Contraindications
Contraindications for the procedure are pathologic conditions of the sacrum that prevent adequate electrode placement (such as spina bifida), skin disease at the area of
implantation,anal sphincter damage amenable to direct repair or requiring a sphincter substitute (e.g., artificial bowel sphincter,dynamic graciloplasty), trauma sequelae
Chapter 22 Innovations in Fecal Incontinence: Sacral Nerve Stimulation
Table 22.1. Sacral nerve stimulation for fecal incontinence: patient selection
315
Report Etiologic spectrum Physiologic and
Matzel et al. (1995b, 2001) Post-fistulectomy,sphincter repair EAS weakness
Matzel (2001)
Vaizey et al. (1999) Scleroderma IAS weakness
Leroi et al.(2001) Post-rectopexy EAS weakness
Rosen et al. (2001) Spinal cord lesion Neurogenic
EAS,IAS external, internal anal sphincter.
Post-Ripstein procedure,
rectal resection
For prolapse
Post-hemorrhoidectomy
Cauda syndrome after lumbar
spine fracture
Primary IAS degeneration IAS degeneration
Obstetric trauma IAS fragmentation
Idiopathic IAS + EAS weakness
Trauma EAS gap <30°,
Meningomyelocele
Multiple sclerosis
morphologic findings
+ EAS defect
+ Urinary incontinence
Superficial EAS gap <60°
with micturition disorders or low bladder capacity, pregnancy, bleeding complications, psychological instability, low mental capacity, and the presence of a cardiac
pacemaker or implantable defibrillator.
22.2.3 Selection Process
Patients are selected for operative implantation of a permanent neurostimulation device on the basis of clinical improvement during test stimulation.At present no other
predictor of functional outcome with chronic stimulation exists. The test stimulation
procedure is most commonly considered therapeutically effective if the frequency of
episodes of fecal incontinence documented by bowel-habit diary is alleviated by at
least 50% (Matzel et al.1995b, 2004) and if the improvement is reversible after discontinuation of temporary stimulation.
The method of choice for permanent stimulation is the unilateral implantation of a
foramen electrode on the spinal nerve site demonstrated to be therapeutically effective during the test stimulation phase.Bilateral foramen electrodes should be considered if unilateral test stimulation is insufficient and bilateral test stimulation reveals
acceptable results (Stadelmaier et al. 2001; Matzel et al. 2002). Cuff electrode implantation can be indicated (as stated above) if foramen electrode placement is problematic
(Matzel et al.2001).
316
Klaus E. Matzel,Uwe Stadelmaier,Werner Hohenberger
22
(Months)
a
Temporary Permanent
6.0†
24
14 (6–48)
c
d
b, c
NA 2
NA 0.5 (0–2)
d
b
14 (6–48)
d
Report Patients Prestimulation Stimulation Follow-up
Table 22.2. Sacral nerve stimulation for fecal incontinence: clinical results (frequency of episodes of incontinence to solid or liquid stool over a 7-day period)
Single center
Matzel (2001) 6 9 (2–19) 1.5 (1–5) 0 (0–1) 59 (5–70)
Leroi et al.(2001) 6 2 (1–7) 0 (0–4) 0.5 (0–2) 6 (3–6)
Ganio et al. (2001a) 5 3 (2–14) 0 0 14 (5–37)
Rosen et al. (2001) 16 2 (1–5) NA 0.7 (0–5) 15 (3–26)
Kenefick et al.(2002b) 15 11 (2–30) 0 (0–7) 0 (0–4) 24 (3–80)
Ripetti et al. (2002) 4 12
Altomare et al.(2004) 14 14 (11–14)
Uludag et al. (2002) 27 8.7 (2–38) 0.7 (0–10) 0.5 (0.5–0.7)
Multicenter
Ganio et al. (2001b) 16 5.5 (1–19) NA 0 (0–1) 10.5 (3–45)
Matzel et al.(2004) 34 8.3 (1.7–78.7) NA 0.75 (0–25) 23.9 (1–36)
Cleveland Clinic Continence Score
Malouf et al. (2000) 5 16 (13–20) – 2 (0–13) 16
Matzel et al.(2003) 16 16 (12–19) – 2 (0–7) 32.5(3–99)
Rasmussen and Christiansen (2002) 10 19.5 (14–20) – 5.5 (0–20) 4.5 (1–12)
Altomare et al.(2004) 14 15 (12.5–17.5) – 5.7 (2–6)
Data presented as median value, unless otherwise indicated.
Data at last follow-up.bMean value; SD and range not available.cFollow-up value: median of values at published follow-up intervals.dMedian values during a 2-week period.
NA not available.
a
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