GASTROENTEROLOGY 2004;126:S48 –S54
TREATMENT OPTIONS FOR FECAL INCONTINENCE
Surgical Treatment Options for Fecal Incontinence
ROBERT D. MADOFF
Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, Minnesota
Although surgical therapy has been shown to be an effec-
tive treatment of anal incontinence, few properly controlled
randomized studies have confirmed its efficacy or com-
pared it with biofeedback or other less invasive forms of
treatment. Overlapping sphincteroplasty, the most com-
mon procedure, seems to confer substantial benefits on
patients with sphincter disruptions. However, recent data
suggest that results following sphincteroplasty deteriorate
with time. There is also disagreement about whether
pudendal nerve conduction studies can be used to predict
outcome after surgical repair. Salvage options for patients
with refractory fecal incontinence include passive or elec-
trically stimulated muscle transfer procedures, implanta-
tion of an inflatable artificial anal sphincter, and sacral
nerve stimulation. Stimulated graciloplasty is the most
commonly used muscle transfer procedure; good to excel-
lent results are reported from a small number of high-
volume centers, but multicenter trials with less experi-
enced surgeons have shown a high morbidity rate
associated with the procedure. The artificial anal sphincter
provides good restoration of continence for most patients
who retain the device, but a significant explantation rate
due to infection or local complications remains problem-
atic. Sacral nerve stimulation has shown promising early
results with minimal associated morbidity. There is a crit-
ical need for controlled long-term studies that use objective
data collection methods, standardized outcome measures,
and validated quality-of-life assessment instruments.
he efficacy of surgery for fecal incontinence remains
T difficult to assess despite the publication of numer-
ous studies. Most series are retrospective and small in
size. Randomized trials are a rarity. Methods of data
collection are not standardized and vary widely in re-
ports. No validated fecal incontinence severity score has
been universally accepted.1 Although a symptom-specific
fecal incontinence quality-of-life scale has recently been
validated2 and is gaining widespread use, most studies
reported to date lack adequate quality-of-life data.
Overlapping Sphincter Repair
(Sphincteroplasty)
There is general agreement that overlapping
sphincter repair is appropriate first-line therapy for in-
continent individuals with significant sphincter defects.
However, there have been no randomized trials compar-
ing sphincteroplasty with nonsurgical therapies such as
biofeedback. Table 1 shows the results of sphinctero-
plasty series reported since 1984 that included at least 30
patients.3–15 Varying definitions notwithstanding, ap-
proximately two thirds of patients who undergo sphinc-
teroplasty seem to gain substantial benefit from the
operation. However, the extent of improvement reported
in these studies is based almost exclusively on patient
recall, and data based on prospective diaries are lacking.
Moreover, validated prospective quality-of-life data have
yet to be reported for patients who have undergone
sphincteroplasty. These shortcomings are particularly
significant given that overlapping sphincteroplasty is
widely considered to be the accepted standard for incon-
tinent patients with sphincter disruptions.
Recently reported studies have questioned the long-
term stability of overlapping sphincteroplasty. Halverson
and Hull contacted 49 of 71 patients at a median fol-
low-up of 69 months after sphincteroplasty; 24 (54%)
were incontinent of liquid or solid stool and only 6
(14%) were fully continent.16 Four patients had under-
gone fecal diversion at the time of follow-up. Karoui et
al.17 evaluated a cohort of patients at 3 months (n ⫽ 86)
and 40 months (n ⫽ 74). During that period, the rate of
total continence decreased from 49% to 28%; conversely,
the rate of incontinence to stool increased from 19% to
49%. Malouf et al.18 studied the results of overlapping
sphincteroplasty in a cohort of women who had been
treated at least 5 years earlier for obstetric injuries. At a
median follow-up of 77 months, 47 patients were con-
tacted, of whom 38 had no stoma and did not undergo
© 2004 by the American Gastroenterological Association
0016-5085/04/$30.00
doi:10.1053/j.gastro.2003.10.015
January Supplement 2004 SURGICAL THERAPY FOR FECAL INCONTINENCE S49

Table 1. Overall Results of Anterior Overlapping Sphincteroplasty

Author, year No. Excellent/good (%) Fair (%) Poor (%)
Fang et al., 19844 76 58 38 4
Hawley, 19855 100 52 32 18
Ctercteko et al., 19886 44 54 32 18
Jacobs et al., 19907 30 83 17 0
Fleshman et al., 19918 55 72 22 6
Gibbs and Hooks, 19939 33 73 15 12
Londono-Schimmer et al., 199410 60a 60 18 22
Engel et al., 199411 55 79 17 4
Oliveira et al., 199612 55 71 9 20
Nikiteas et al., 199613 42 67 14 19
Gilliland et al., 199814 100 60 19 21
Rasmussen et al., 199915 38 68 13 18
Buie et al., 20013 158 62 26 12
891 (total) 66 (mean) 22 (mean) 12 (mean)
aAnterior repairs.

Adapted and reprinted with permission from Buie et al.3

additional surgery for incontinence. None of the women
was fully continent to both stool and flatus, and 20
(42%) wore a pad for incontinence. Thirty patients
(79%) had passive soiling, and 32 (89%) had fecal ur-
gency.18 Baxter et al. noted an increase in solid stoolin-
continence from 36% to 58% in a cohort of patients who
reported functional results at both 3-year and 10-year
follow-up after sphincteroplasty.19
The causes of long-term deterioration in function re-
main uncertain. Breakdown of the repair is a common
cause of early failure but seems an unlikely mechanism
many months after initial clinical success. Other hypoth-
eses include aging, scarring, and progressive pudendal
neuropathy related either to the initial injury or to the
subsequent repair.
One area of significant controversy is the relationship
of pudendal nerve function to the outcome of sphinctero-
plasty. Although this relationship may seem intuitively
obvious, researchers have identified a number of concerns
regarding the assessment of pudendal nerve function,
which is typically done by determining pudendal nerve
terminal motor latency.3 Malouf et al., for example,
found no association between pudendal nerve status and
long-term outcome.18 Published series have reported
conflicting results (Table 2).3,10,11,13,14,20 –25
The optimal salvage therapy for patients whose
sphincteroplasty has failed, or for those who are not
candidates for the procedure, remains uncertain. Biofeed-
back, where available, has been reported to be effective
alone or following sphincteroplasty.26 Current options
for salvage therapy include muscle transfer procedures,
implantation of an artificial anal sphincter, and sacral
nerve stimulation.
Muscle Transfer Procedures
Pickrell et al. described the use of gracilis trans-
position to function as a neosphincter in 1952,27 and
Corman reported good results with passive gracilis wraps
in 1985.28 More recently, Faucheron et al. confirmed that

Table 2. Effect of Pudendal Neuropathy on Outcome After Sphincteroplasty

Normal PNTML Abnormal PNTML
Author, year Institution n success (%) success (%) P
Laurberg et al., 198820 St. Mark’s 19 80 11 ⬍0.05
Wexner et al., 199121 Cleveland Clinic, FL 16 92 50 NS
Londono-Schimmer et al., 199410 St. Mark’s 94 55 30 ⬍0.001
Engel et al., 199411 St. Mark’s 55 — — NS
Felt-Bersma et al., 199622 Vrije University 18 — — NS
Simmang et al., 199423 Washington University 14 100 67 NS
Sitzler and Thomson, 199624 St. Mark’s 31 67 63 NS
Nikiteas et al., 199613 Birmingham 26 67 53 NS
Sangwan et al., 199625 Lahey Clinic 15 100 14 ⬍0.005
Gilliland et al., 199814 Cleveland Clinic, FL 100 63 10 ⬍0.01
Buie et al., 20013 University of Minnesota 89 61 71 NS

PNTML, pudendal nerve terminal motor latency; NS, not significant.

Adapted and reprinted with permission from Buie et al.3
S50 ROBERT D. MADOFF GASTROENTEROLOGY Vol. 126, No. 1

Table 3. Efficacy of Dynamic Graciloplasty for Fecal Incontinence

Geerdes et al.36a DMP trial34b DGTSG trial35c

n Success (%) n Success (%) n Success (%)

Acquired incontinence 54a 45 (83) 75 53 (71) 83 45 (54)
Congenital incontinence 13 7 (54) 18 9 (50) 13 8 (62)
Overall 67 52 (78) 93 62 (67) 96 53 (55)

DMP, dynamic muscle plasty; DGTSG, Dynamic Graciloplasty Therapy Study Group.
aAcquired incontinence: trauma, 34 patients; pudendopathy, 20 patients; mean 2.7-year follow-up.
bTwenty-four–month follow-up.
cTwelve-month follow-up.

Adapted and reprinted with permission from Buie.37

a significant number of patients improve with passive
gracilis wraps alone.29 Less common alternatives for pas-
sive muscle neosphincters include bilateral nonstimu-
lated graciloplasty30 and bilateral gluteus maximus
transposition.31–33
Dynamic graciloplasty (the addition of electrical stim-
ulation) was devised in an effort to improve the func-
tional results of nonstimulated gracilis transposition.
Shortcomings of nonstimulated graciloplasty include the
inability of patients to voluntarily contract the trans-
posed muscle and the physiologic inability of the muscle
to maintain tonic contraction over prolonged periods.
The addition of electrical stimulation addressed each of
these concerns, first by causing conversion of type II
(fast-twitch, fatigue-prone) to type I (slow-twitch, fa-
tigue-resistant) muscle fibers and second by providing
continuous muscle stimulation without the need for
continuous conscious effort on the part of the patient. In
practice, the patient deactivates the pulse generator by
telemetry when he or she wishes to effect defecation.
Dynamic graciloplasty has been described in a number
of small single-center series and in 2 multicenter tri-
als.34,35 The largest single-center experience was reported
by Geerdes et al.36 No randomized controlled trials have
been performed.
The results of dynamic graciloplasty for fecal inconti-
nence, as reported in the 3 largest reported series, are
shown in Table 3.34 –37 However, the results must be
interpreted with caution because the means of data col-
lection and criteria for success vary significantly between
series (Table 4).34 –37 Chapman et al. recently published a
systematic review of dynamic graciloplasty in the treat-
ment of fecal incontinence.38
Dynamic graciloplasty is associated with substantial
morbidity (Table 5).34 –37 Of the 123 patients enrolled in
the Dynamic Graciloplasty Therapy Study Group proto-
col,35 91 (74%) had a total of 189 complications. Infec-
tion is the most frequent cause of serious complica-
tions34 –36,39 and the most frequent cause of failure of the
procedure.34 The infection rate is also related to the
extent of the operating surgeon’s experience.34
Dynamic graciloplasty continues to be performed in
Europe and Canada, but the hardware for the procedure
has not been approved for use in the United States. For
now, its role is largely limited to a small number of
centers in which adequate patient volume and surgical
experience help to assure low morbidity and satisfactory
functional outcomes.
Artificial Anal Sphincter
The artificial anal sphincter represents an alter-
nate approach to dynamic anal sphincter replacement.
Like the dynamic graciloplasty, the artificial anal sphinc-
ter is placed around the native sphincter via perianal
tunnels. The device remains inflated until the patient
wishes to defecate, at which time the device is deacti-
vated by a manual pump implanted in the scrotum or
labia majora. The current device (Acticon Neosphincter;
American Medical Systems, Minnetonka, MN) and its
precursor (AMS 800) are both modifications of a system
originally designed for urinary incontinence.

Table 4. Means of Data Collection and Criteria for Success

Series Data collection Success (no stoma) Success (stoma)
Geerdes et al.36 Patient recall Williams score 1–2 Williams score 1–2
Dynamic muscle plasty trial34 Patient recall 70% reduction Complete continence
Dynamic Graciloplasty Therapy Study Group trial35 Daily diary 50% reduction ⬎50% of bowel movements continent
January Supplement 2004 SURGICAL THERAPY FOR FECAL INCONTINENCE S51

Table 5. Patient Morbidity Following Dynamic Graciloplasty

Dynamic Graciloplasty Therapy Study Group
Geerdes et al.36 (%) Dynamic muscle plasty trial34 (%) trial35 (%)
Major infections 9 (13) 27 (29) 17 (14)
Minor infections 1 (2) 28 (30) 28 (23)
Wound, nonhealing — — 14 (11)
Muscle wrap problems 10 (15) 4 (4) 9 (7)
Pain — 25 (27) 34 (28)
Device/lead 12 (18) 11 (12) 16 (13)
Other 2 (3) 9 (10) 10 (8)
Constipation 13 (19) — 28 (23)
Patients with complications 36 (54) — 91 (74)
Total patients in study 67 93 123
Death 0 0 1

NOTE. Morbidity summarized by patient, not by individual events. Some patients had more than one event.
Adapted and reprinted with permission from Buie.37

Early results using the AMS 800 system showed the
feasibility of the technique, with approximately 75% of
patients retaining a functioning device after mean dura-
tions of 2040 and 5841 months. Christiansen et al. re-
ported that 8 of 17 patients (47%) retained a functioning
device more than 5 years after implantation.42 Most
patients had good functional results, although control of
liquid stool and flatus was imperfect for some pa-
tients.40 – 42
More recent reports indicate that patients who were
successfully implanted with the Acticon Neosphincter
experienced substantial functional improvement (Table
6).43– 47 However, in virtually all reported series, infec-
tion, erosion, and device malfunction have remained
significant problems (Table 7).43– 48 Several patients have
experienced obstructed defecation following otherwise
successful implantation.
Wong et al. recently reported the results of a large,
multicenter prospective trial using the Acticon Neo-
sphincter.49 Of the 112 patients who underwent implan-
tation, 51 patients required 73 operative revisions and 41
patients required device explantation. The overall success
rate was 53%, and 85% of patients who retained their
device achieved a successful outcome.49
Sacral Nerve Stimulation
Sacral nerve stimulation, originally developed for
urinary voiding dysfunction, has been used to success-
fully manage fecal incontinence. Matzel et al. first re-
ported this technique in 1995.50 Vaizey et al. evaluated
sacral nerve stimulation in 12 patients treated for 1 week
with percutaneous leads and external pulse generators.51
Of the 9 evaluable patients (3 had early lead dislodg-
ments), 7 became fully continent and one improved
markedly.
There are relatively few reports on the results of
chronic sacral nerve stimulation, but results have been
encouraging. Matzel et al. had successful results in 6 of
6 patients with permanent implants at 5– 66 months of
follow-up, although 2 devices had to be removed due to
pain.52 Leroi et al. implanted 6 patients and reported
improvement in 3 of the 5 evaluable patients at 6
months.53 Ganio et al. noted improvement in all 16

Table 6. Artificial Anal Sphincter: Functional Outcome

Continence grading scale

Author, year No. of patients Follow-up (mo) Before implantation After implantation
Lehur et al., 200043a 20 20 (6–35)b 106 (13)c 25 (25)c
O’Brien and Skinner, 200044d 10 NA 19 (18–20)b 3 (0–6)b
Vaizey et al., 199845a 5 9 (4–12)b 96.2 (70–108)b 19.4 (0–61)b
Dodi et al., 200046d 6 10.5 (4–23)b 18.7 (1.6)c 2.1 (2.6)c
Ortiz et al., 200247d 15 26 (7–48)b 18 (14–20)b 4 (0–14)b

NA, not assessed.

aAmerican Medical Systems incontinence score.

Values are bmean (range) or cmean (SD).

dCleveland Clinic Florida Scale.

Adapted and reprinted with permission from Ortiz et al.47

S52 ROBERT D. MADOFF GASTROENTEROLOGY Vol. 126, No. 1

Table 7. Artificial Anal Sphincter: Complications, Explants, Reimplants, and Surgical Reoperations
Patients
with No. of
No. of Mechanical definitive Early Late patients
Author, year patients Infection Erosiona failureb Explants Reimplants explants reoperationc reoperationd reoperated
Lehur et al.40, 2000 24 1 3 3 8 3 4 3 7 7
Malouf et al.48, 2000 18 7 2 2 12 NA 12 8 4 12
O’Brien and Skinner44,
2000 13 2 2 0 3 1 1 4 3 5
Vaizey et al.45, 1998 6 1 1 0 1 0 1 2 1 1
Dodi et al.46, 2000 8 2 1 0 2 0 2 2 0 2
Ortiz et al.47, 2002 22 3 5 2 9 2 7 2 10 9

NA, not assessed.

aInvolving anal cuff, connecting tubes, pump.
bCuff leak, balloon rupture, pump leak, painful implant site.
cSurgical reoperation in the postoperative period.
dReoperation during follow-up.

Adapted and reprinted with permission from Ortiz et al.47

implanted patients followed up for a mean of 15.5
months.54 Rosen et al. performed acute peripheral nerve
testing in 20 patients and implanted 16 with successful
test stimulations.55 Median follow-up was 15 months.
All patients had marked improvement in their inconti-
nence, but 4 patients subsequently required explantation
for infection or lead dislodgment. Kenefick et al. re-
ported marked improvement in each of 15 patients who
underwent permanent implantation at a median fol-
low-up of 24 months.56 Quality-of-life improvements
following sacral nerve stimulation have now been docu-
mented in several series.55,56
Physiology studies in patients with sacral nerve stim-
ulation have shown a consistent picture of improved
resting and squeeze anal pressures as well as improved
rectal sensation.52,54 –56 However, the mechanism of ac-
tion of sacral nerve stimulation remains uncertain. Pos-
sible mechanisms of action include stimulation of sensory
afferents, stimulation of motor efferents, modulation of
neural reflexes, and a combination of these effects.
Conclusion
Patients with fecal incontinence now have several
surgical options for treating the disorder. Ironically, the
most established approach, overlapping sphincteroplasty,
has been subject to the least stringent study protocols.
Newer competing therapies are now being studied pro-
spectively with diary data and validated quality-of-life
instruments. However, experience with novel therapies
remains limited and must be expanded before their
proper role in incontinence management can be defined.
Important fundamental research must be performed to
advance the field of fecal incontinence therapy. Consen-
sus is needed with respect to data collection (diary vs.
recall), scoring systems, and quality-of-life assessment.
There is a desperate need for properly conducted and
adequately powered randomized trials to address issues in
incontinence therapy as fundamental as surgical therapy
versus biofeedback for the initial treatment of patients
with sphincter defects. Longitudinal studies are needed
to accurately assess the long-term results of various ther-
apies, including overlapping sphincteroplasty. Centers of
expertise must be developed to ensure fair assessment of
novel surgical therapies that are minimally affected by
individual surgeons “climbing the learning curve” for
new techniques. Only after these fundamental questions
have been answered can other important but secondary
issues, such as identifying the proper techniques for
sphincteroplasty or assessing the effect of pudendal neu-
ropathy on treatment results, be systematically ad-
dressed.
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Address correspondence to: Robert D. Madoff, M.D., F.A.C.S., Divi-
sion of Colon and Rectal Surgery, University of Minnesota, 393 North
Dunlap Street, Suite 500, Minneapolis, Minnesota 55104-4206.