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SECTION III
Treatment of Fecal Incontinence
Introduction
Criteria for patient selection to a certain treatment
are of central importance in the management of fecal
incontinence (FI). Even though the understanding of
continence physiology has improved, there persists a
lack of comprehensive knowledge regarding the very
complex mechanisms by which various structures
contribute to the regulation of continence control. It
is now assumed that a continuous modulation of dif-
ferent stimuli is necessary to effectively maintain the
various functions involved with continence. On the
other hand, the instruments available to measure or
analyze parameters associated with continence,
albeit numerous and sometimes sophisticated, are
not used in a standardized manner, so that data
obtained at one center are not comparable with those
obtained in another. Also, the entire diagnostic
workup is still debatable, being routinely limited to
clinical examination in the opinion of some, whereas
others recommend extensive evaluation. However,
other aspects must be considered in the decision-
making process surrounding treatment choice. These
aspects include the patient’s background and feelings
about his or her FI and the clinician’s attitude toward
proposing a particular treatment. Usually, patients
are very frustrated about their FI, and are sometimes
convinced that it is ineluctable and incurable. Some-
times they are highly motivated to find the right solu-
tion but want to avoid suffering or very complicated
solutions that can significantly alter their lifestyle.
Sometimes they are so depressed about their FI that
they are willing to undergo whichever form of treat-
ment their physician recommends.
Whereas it is necessary for the physician to con-
sider the patient’s perspective when making a treat-
ment decision, it is also necessary to consider the
consequences of treatment, some possibly ineffec-
tive, when deciding upon a first-line approach. For
instance, submitting a patient with very poor conti-
nence to a prolonged period of rehabilitation during
which significant improvement is not seen could
increase the patient’s skepticism to the point of
refusing any other form of therapy. On the other
hand, choosing a complex therapy as the first-line
approach, for example, dynamic graciloplasty or arti-
ficial sphincter, must be based on very strict criteria
in order to avoid submitting the patient to excessive
treatment. Finally, but fundamental in our opinion, it
is unreasonable and irresponsible to offer the patient
a stoma as a unique solution for FI without an appro-
priate diagnosis and a rational therapeutic approach.
Another aspect that influences patient selection to
treatment is the evaluation of results from the appli-
cation of different therapies. These evaluations
should help the identification of specific subgroups
of patients to be recommended for a specific
approach as well as allow assessment of the effective-
ness of a particular therapy. However, there are many
published reports about treatment of patients inho-
mogeneously selected to a therapy. Moreover, the
rapid evolution of new techniques has determined
that in a few years, the same type of patients will be
treated with very different methods. Indeed, treat-
ment selection criteria are rapidly changing parallel
with technical advances. On the other hand, there
remains debate about how to measure the effective-
ness of a treatment for FI: reduction of FI episodes;
positive impact on quality of life; changing of physi-
ological parameters.
Patient Selection
Baseline evaluation of symptoms described by a
patient presenting with FI is fundamental in order to
establish severity of continence dysfunction and its
impact on the patient’s lifestyle. Usually, this can be
derived from a clinical assessment (including clinical
history and physical examination), as well as from
the evaluation of a diary kept by the patient concern-
ing normal bowel movements and episodes of FI,
specifying which kind of material has been lost (gas,
liquid, solid stool). Frequency, circumstances, and
the patient’s sensations and attempts to avoid leak-
age before and during stool passage, are of interest.
Patient Selection and Treatment Evaluation
Carlo Ratto,Angelo Parello, Lorenza Donisi, Francesco Litta,
Giovanni B. Doglietto
13
Clinical features allow the physician to establish an FI
score according to different available scales. There-
after, more information about the pathophysiology
of FI can be gleaned from instrumental examination,
including anorectal manometry (ARM) and sensory
testing, endoanal ultrasound (EAUS), anorectal elec-
trophysiology (AREP), magnetic resonance (MR),
and defecography.
Instrumental assessment is worthwhile because
clinical findings alone are not sufficient to correctly
plan treatment. Ternent et al. [1] found that using
ARM, EAUS, and pudendal nerve terminal motor
latency (PNTML) changes the treatment plan in 20%
of patients. This tendency was confirmed by the same
group of researchers [2] on 90 patients submitted ini-
tially to a clinical evaluation from which a pretest
therapeutic plan was documented (medical for 45
patients, surgical for 45 patients). Thereafter, ARM,
EAUS, and PNTML were performed, and a posttest
management consensus was reached. In 10% (nine
patients), a change of treatment plan was observed
after the physiological tests (from medical to surgical
in five patients; from surgical to medical in three
patients; change of surgical procedure in one
patient). Within patients assigned to a pretest med-
ical treatment, EAUS was the only anorectal test sig-
nificantly responsible of changing the strategy:
among patients indicated for pretest surgical
approach, EAUS and PNTML prompted the varia-
tion. In a similar study performed at our institution
in 2002 involving 63 patients (unpublished data), we
found that clinical features alone were unable to indi-
cate treatment in 25 patients (39.7%), whereas after
ARM, EAUS, and AREP, these “undefined” patients
were assigned to medical treatment in 13 cases and to
surgery in 12 cases. For the entire group of patients,
including those “undefined,” a disagreement
between pretest and posttest treatment plan was
found in 30 cases (47.6%). In five patients (7.9%),
there was a change of pretest approach (from medical
to surgical in two; from surgical to medical in three).
Numerous other studies have supported the integra-
tion of clinical assessment and physiological tests to
improve the understanding of FI and patient treat-
ment selection [3–6].
Medical Treatment
Medical treatment includes diet, drugs, supportive
measures, rehabilitation, and biofeedback. They are
usually chosen for either “elective” reasons or for
patients who cannot be treated by a surgical
approach. Specifically, poor clinical conditions limit-
ing anesthesia and/or surgery could be valid criteria
for a nonoperative approach, whereas a patient’s age
could be only relatively limiting. On the other hand,
psychological problems or disturbances should sug-
gest avoidance of very complex surgical procedures
that require patient compliance. Specific bowel dis-
eases (chronic inflammatory diseases; irritable bowel
syndrome) with uncontrolled symptoms should con-
traindicate a major surgical approach. When life-
threatening clinical conditions are involved (evolv-
ing diseases; chronic diseases; neoplasms not radical-
ly treated), the choice of treatment should consider
the patient’s life expectancy and the possible benefits
in quality of life.
“Elective” indication for medical therapy should
include minor FI without physiologic or morpholog-
ic alterations; in cases with minor abnormalities, a
medical approach could be considered as a first-line
intervention. Also, individuals with continence dys-
functions related to altered feces quality (i.e., diar-
rhea) should be expected to gain benefit from a con-
servative treatment approach. In this area, the
patient must be advised to improve perianal hygiene,
carefully use absorbent cotton diapers and tampons,
and reduce or avoid foods that induce loose stools
and increase gastrointestinal transit and gas produc-
tion (milk derivates; legumes; excess fiber). Diarrhea
needs to be fully investigated and, consequently,
treated with medication when appropriate. Specific
drug treatment has to be initiated in cases of chronic
bowel disease. Also, the pathophysiology of soiling
should be fully elucidated to determine between
operative and nonoperative treatment; when it is
minor, occasional, or without either significant phys-
iologic dysfunction or sphincter lesions, a conserva-
tive approach can be attempted using postevacuation
irrigating water enema or anal plugs as supportive
measures.
Pelvic floor rehabilitation, including biofeedback,
kinesitherapy, sensory retraining, and electrostimu-
lation, is frequently regarded as a first-line treatment
for FI. However, disagreement exists about indica-
tions for rehabilitative techniques. Lack of standard-
ized methods makes it difficult to compare results of
this approach, even in patients accurately selected.
Moreover, in the limited number of well-conducted
studies, there is no agreement concerning outcome
parameters to measure or predict therapy outcome
[7, 8]. A rational modulation of the algorithm for
rehabilitation could play a key role for therapy suc-
cess. Patient compliance and good psychological sta-
tus are preliminary requirements for rehabilitation,
being predictors of therapy success [9, 10]. Selection
criteria cannot be based on anal pressures [11–14],
whereas altered threshold and rectal urgency sensa-
tions have been found to be predictive of a positive
treatment response [7, 14–16]. Sensory retraining
could be used both in individuals with reduced rectal
154
C. Ratto, A. Parello, L. Donisi, F. Litta, G.B. Doglietto
Chapter 13 Patient Selection and Treatment Evaluation
sensation and in patients with very high sensory lev-
els [16–18]. Although controversies exist about the
outcome predictive value of PNTML in individuals
undergoing rehabilitation [7, 8, 13], its alteration
seems to be regarded as a predictor of negative
response [7, 8]. However, an external anal sphincter
defect is not an absolute negative predictor of success
[7, 8, 19]. Biofeedback, electrostimulation, and kine-
sitherapy could be scheduled in patients with such a
defect.
Surgical Treatment
Until the recent past, in cases of intractable severe FI,
criteria for selecting patients to surgical treatment
concerned sphincter lesions or pudendal neuropathy
with perineal descent and altered anorectal angle. In
the former condition, a sphincteroplasty was indicat-
ed in cases of limited lesion without PNTML alter-
ation, whereas a sphincter replacement operation
(dynamic graciloplasty, artificial sphincter, gluteo-
plasty) was indicated when a wide lesion, fragmented
sphincters, or failure of previous sphincteroplasty
occurred. In the latter condition, a postanal repair
was indicated. Recently, other therapies have been
more widely used, such as injectable bulking agents
or the recently introduced radiofrequency. Since
1995, sacral nerve stimulation (SNS) has been intro-
duced into the panorama of treatment options, deter-
mining a significant rearrangement of selection crite-
ria.
Sphincteroplasty
Sphincter lesions due to obstetric trauma (third- and
fourth-degree tears) have traditionally been submit-
ted electively to sphincteroplasty. This technique can
be performed by edge-to-edge approximation or
overlapping of the external anal sphincter (Fig. 1).
Immediate repair, at the time of delivery or delayed
to 24 h, has been suggested to obtain best results.
However, sphincteroplasty can frequently be per-
formed a few decades after childbirth, when the
patient presents clinically with FI. Manometric
parameters (squeeze pressure; resting pressure; anal
canal length) seem not to be useful for patient selec-
tion to sphincteroplasty, whereas a pudendal neu-
ropathy, measured by a prolonged PNTML (particu-
larly if bilateral), should be considered as a predictor
of poor outcome [20–26]. However, conflicting
results are also reported [27–31], attributable to cor-
rect definition of PNTML normality, adequate evalu-
155
Fig. 1a–f. Sphincteroplasty. a Perineal incision. b The external anal sphincter is isolated at the level of a scar. c The external
anal sphincter is incised at the level of the scar. d The overlapping sphincteroplasty is prepared. e Multiple stitches are
placed. f The overlapping sphincteroplasty is completed
a
d
e
f
b
c
ation of pudendal neuropathy when assessed by stan-
dard PNTML measurement with St. Mark’s electrode,
and the role of symmetric pudendal innervation [31].
Although EAUS is determinant today in diagnosing a
sphincter tear, ultrasonographic aspects are not con-
sidered valid criteria to select patients to this proce-
dure. To improve the long-term results displayed by
sphincteroplasty alone, which are sometimes limited
[32–34], this operation has been performed within a
total pelvic floor repair [35] or with anterior levator-
plasty [36]. However, again, anorectal physiological
parameters were not predictive of symptom
improvement.
Postanal Repair
Neuropathic FI associated with perineal descent and
without sphincter lesions seems, theoretically, to be
the best indication to postanal repair. Unfortunately,
no physiological parameters have been found to be
indicative for this approach [37–40]. Considering the
limited long-term effectiveness of this treatment,
patients with these indications could be more effec-
tively approached by other procedures. Indeed, indi-
cations for postanal repair have been significantly
reduced over time. The procedure has been advocat-
ed as part of a total pelvic floor repair in conjunction
with anterior levatorplasty.
Dynamic Graciloplasty,Artificial Bowel Sphincter,
Gluteoplasty
These procedures must be regarded as major sphinc-
ter replacement operations, dedicated only to
patients with very severe FI due to a wide sphincter
lesion (more than half the circumference) or frag-
mented sphincters not amenable to neither sphinc-
teroplasty or other surgical approaches (i.e., SNS). In
case of failure of previous sphincteroplasty (when
there is no indication to redo it), which is not suitable
for SNS, these techniques can also be indicated.
Moreover, if severe FI is consequent to neuropathy or
anorectal malformations, one of these operations
could be performed (specifically, in cases of neu-
ropathy when SNS has failed). Usually, patients pres-
ent a very low or absent squeeze pressure, which is
associated with a decreased or absent resting pres-
sure if an internal sphincter lesion/alteration coex-
ists. When pudendal neuropathy occurs, PNTML
could be altered. Dysfunctions of rectal sensations
should be regarded as negative predictors of success,
as reported in different experiences [41–43]. The
156
C. Ratto, A. Parello, L. Donisi, F. Litta, G.B. Doglietto
Fig. 2a–f. Dynamic graciloplasty, a skin incision, b gracilis muscle is exposed and c isolated, d perianal tunnel is prepared,
e gracilis muscle has been transposed in perianal space and a “gamma” loop is prepared, f the electrostimulator (connect-
ed to the electrodes implanted close to the nerve pedicle of the gracilis muscle) is placed in a subfascial pocket at the level
of the rectum abdominis muscle
abc
d
e
f
Chapter 13 Patient Selection and Treatment Evaluation
only major contraindications to the sphincter
replacement procedures are very severe chronic
bowel diseases causing intractable defecation dys-
functions (severe diarrhea as well as severe constipa-
tion) and coexistence of rectal prolapse, intussuscep-
tion, rectocele, or enterocele.
Although indications for dynamic graciloplasty
(Fig. 2), artificial bowel sphincter, and gluteoplasty
overlap, there are various differences between them
concerning surgeon preference and expertise, tech-
niques and materials used, evaluation of periopera-
tive morbidity, and long-term results [44–56]. These
aspects are treated in details in other chapters in this
book. It must be noted that because all outcome vari-
ables can reach very poor or very good levels prima-
rily in relation to correct indications and surgeon
expertise, it seems reasonable that these operations
must be performed by surgeons dedicated to the
management of severe FI.
Sacral Nerve Stimulation
SNS now plays a central role in the algorithm of FI
management (Fig. 3). Even if of recent clinical appli-
cation in anorectal dysfunction [57], this approach
has rapidly expanded, and step by step, acceptable
indications have been suggested. Initial applications
concerned patients with dysfunctions of nonlesioned
striated anal muscles, then with a prevalent neuro-
genic etiology [58–64]. Thereafter, as clinical use and
understanding of action mechanisms made progress,
SNS expanded to other indications, including idio-
pathic sphincter degeneration, iatrogenic internal
sphincter damage, partial spinal cord injury, sclero-
derma, limited lesions of internal or external anal
sphincters, rectal prolapse repair, and low anterior
resection of the rectum [65–78]. Actually, alterations
of the sacrum or skin in the implantation area, very
wide sphincter tears, pregnancy, and very severe
uncontrolled chronic bowel diseases are regarded as
the main contraindications for SNS.
A variety of physiological patterns has been
observed at patient presentation, and, in most stud-
ies, none of these parameters has been elucidated as
a prognostic indicator of outcome. Alterations of any
one manometric parameter did not contraindicate
this therapy. Variations of rectal sensation between
baseline to postimplant toward normal range seem to
be related to better results, despite whether baseline
values were higher or lower than normal [79, 80]; this
would demonstrate the “modulation” effect of SNS.
157
Fig. 3a–f. Sacral nerve stimulation, a patient’s position in the operating room, b following local anesthesia, a needle is
inserted through the right third sacral foramen, c a needle has been inserted into the left third sacral foramen, and the
electrode introducer has been placed through the right third sacral foramen; a permanent quadripolar electrode is shown,
d insertion of the permanent quadripolar electrode through the introducer, e bilateral placement of permanent electrodes
into the right and left third sacral foramina, f subcutaneous placement of the electrostimulator. Reprinted with permis-
sion from [88]
abc
d
e
f
Prolonged PNTML, previously considered a negative
prognostic factor for treatment success, now is
regarded, per se, as a noninfluencing indicator. Other
studies have underlined the influence of SNS on the
central nervous system [81, 82], explaining why this
approach could be effective in partial spinal cord
lesions but ineffective in cases of total lesions. Very
recently, Gourcerol et al. [83] investigated prognostic
factors associated with SNS success during tempo-
rary and definitive stimulation. They found that only
patient age was prognostic of outcome during tem-
porary test, whereas bulbocavernosus reflex latency
was the only factor influencing success after defini-
tive device implantation. In their opinion, patients
with neurogenic FI should be candidates for SNS.
Injectable Bulking Agents
This treatment approach is regarded as attractive
because it is not invasive. However, only a very accurate
patient selection can allow positive effects of bulking
agents on FI. Usually, patients with either limited inter-
nal sphincter lesion or a weak anus without tears are
indicated to this kind of treatment. Moreover, individ-
uals who cannot be submitted to other major surgical
approaches due to their poor general clinical conditions
could be amenable to injection of bulking agents. The
increasing variety of agents proposed and used (Fig. 4)
to create a bulking effect, with different methods of
injection (through anal mucosa or transsphincteric),
different placement sites (submucosal or intersphinc-
teric), and different check procedures (digital examina-
tion or EAUS), have determined criteria incomparable
for selecting the most appropriate approach [84].
Radiofrequency
This therapy also seems to be indicated in individu-
als with weak anal sphincters, but lesions contraindi-
cate its use, as does chronic diarrhea, inflammatory
bowel disease, or anal sepsis. Due to the recent clini-
cal application [85–87] and lack of large studies, it is
not possible, at this time, to determine stricter selec-
tion criteria.
158
C. Ratto, A. Parello, L. Donisi, F. Litta, G.B. Doglietto
Fig. 4a–f. Implantation of a new bulking agent for fecal incontinence (FI), the Anal Gatekeeper (Medtronic, Inc., Min-
neapolis, MN, USA), a endoanal ultrasound (EAUS) of a patient with FI following rectal prolapse previously repaired with
Delorme procedure, b following locoregional anesthesia (perineal block), insertion of the introducer through a small skin
incision to reach the intersphincteric space; introducer site should be confirmed by EAUS, c placement of the thin solid
prosthesis through the introducer to reach the intersphincteric space, followed by removal of the introducer, d final check
by EAUS, e coronal and f longitudinal views of EAUS 6 months after four prostheses implant; in 24 h, each prosthesis
became thicker and very soft
a
b
c
d
e
f
Chapter 13 Patient Selection and Treatment Evaluation
Treatment Evaluation
A variety of aspects can affect evaluation of the
effectiveness of a certain therapy for FI. Identifica-
tion of factors reflecting the treatment impact and
methods measuring the improvement obtained is
of crucial importance. This should be derived from
well-conducted studies with a sufficiently large
number of patients selected with strict criteria.
However, frequently, the available reports are
mostly affected by an inhomogeneous patient
selection. Also, criteria used to define response to
therapy are not standardized. This could depend
on the end point of that treatment: care of symp-
toms (i.e., reduction of FI episodes; improved con-
trol of solid vs. liquid stools vs. gas; ability to post-
pone defecation), improvement in quality of life,
improvement in multifactorial aspects (i.e.,
scores), or normalization of physiological parame-
ters (i.e., manometric; electrophysiologic; ultra-
sonographic).
Conceptually, considering a good response as an
improvement of at least 50% in FI could be debat-
able. In fact, in a patient treated for very severe FI,
a 50% reduction in FI episodes (for instance, from
ten to five episodes per week) probably is not
enough to significantly improve that patient’s pre-
treatment quality of life and life style (need to ware
pads; living close to the bathroom; constrained to
stay at home). Moreover, even if perfect control to
solid stools has been regained after treatment,
incontinence to liquids or gas could remain very
detrimental. Because there is disagreement on clin-
ical parameters to define treatment response, avail-
able data from reports must be evaluated thorough-
ly and critically.
On the other hand, the available scoring systems
for FI measurement as well as quality of life ques-
tionnaires are not fully shared. They could be too
vague and subjective. Patient “satisfaction” would
probably be the most comprehensive concept reflect-
ing therapy success, but it is difficult to quantify.
Moreover, each score needs to be validated according
to the patient’s specific social, cultural, and environ-
mental factors.
Physiological parameters are used to demonstrate
the objective impact of a treatment. However, very
frequently, conflicting data are obtained when a sin-
gle parameter is considered because of the multifac-
torial origin of FI. Moreover, the influence of a par-
ticular treatment could be different in different sub-
groups of patients, each with particular physiological
features.
All the above-mentioned considerations highlight
the difficulty of interpreting data from reports on FI
management. In the following chapters, the authors
offer a complete panorama of medical, rehabilitative,
and surgical methods to cure FI. They discuss tech-
niques and results, as well as the pros and cons of
using each approach.
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