13 Patient Selection and Treatment Evaluation

(1)

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 different 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 solution 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 treatment their physician recommends.

Whereas it is necessary for the physician to consider the patient’s perspective when making a treatment decision, it is also necessary to consider the consequences of treatment, some possibly ineffective, when deciding upon a first-line approach. For instance, submitting a patient with very poor continence 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 artificial 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 appropriate diagnosis and a rational therapeutic approach.

Another aspect that influences patient selection to treatment is the evaluation of results from the application 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 effectiveness 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, treatment selection criteria are rapidly changing parallel with technical advances. On the other hand, there remains debate about how to measure the effectiveness of a treatment for FI: reduction of FI episodes;

positive impact on quality of life; changing of physiological 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 concerning 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

(2)

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 medical treatment, EAUS was the only anorectal test significantly 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 treatment 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 limiting 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 diseases (chronic inflammatory diseases; irritable bowel syndrome) with uncontrolled symptoms should contraindicate 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 dysfunctions related to altered feces quality (i.e., diarrhea) 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 physiologic 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 electrostimulation, is frequently regarded as a first-line treatment for FI. However, disagreement exists about indications for rehabilitative techniques. Lack of standardized 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 success. 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 sensations 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

(3)

sensation and in patients with very high sensory levels [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 kinesitherapy 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 indicated in cases of limited lesion without PNTML alteration, whereas a sphincter replacement operation (dynamic graciloplasty, artificial sphincter, gluteoplasty) 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 introduced into the panorama of treatment options, deter- mining a significant rearrangement of selection criteria.

Sphincteroplasty

Sphincter lesions due to obstetric trauma (third- and fourth-degree tears) have traditionally been submitted 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 performed 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 selection to sphincteroplasty, whereas a pudendal neuropathy, 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 correct definition of PNTML normality, adequate evalu-

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

(4)

ation of pudendal neuropathy when assessed by standard 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 considered valid criteria to select patients to this procedure. 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 levatorplasty [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 effectively approached by other procedures. Indeed, indications 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 sphincter replacement operations, dedicated only to patients with very severe FI due to a wide sphincter lesion (more than half the circumference) or fragmented sphincters not amenable to neither sphincteroplasty 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 neuropathy when SNS has failed). Usually, patients pres- ent a very low or absent squeeze pressure, which is associated with a decreased or absent resting pressure 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

Fig. 2a–f.Dynamic graciloplasty, a skin incision, b gracilis muscle is exposed and c isolated, d perianal tunnel is prepared, egracilis 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

a b c

d e f

(5)

only major contraindications to the sphincter replacement procedures are very severe chronic bowel diseases causing intractable defecation dysfunctions (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, techniques 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 application 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 neurogenic etiology [58–64]. Thereafter, as clinical use and understanding of action mechanisms made progress, SNS expanded to other indications, including idiopathic 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 studies, 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.

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, dinsertion 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]

a b c

d e f

(6)

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 definitive 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, individuals 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 intersphincteric), and different check procedures (digital examination or EAUS), have determined criteria incomparable for selecting the most appropriate approach [84].

Radiofrequency

This therapy also seems to be indicated in individuals with weak anal sphincters, but lesions contraindicate its use, as does chronic diarrhea, inflammatory bowel disease, or anal sepsis. Due to the recent clinical application [85–87] and lack of large studies, it is not possible, at this time, to determine stricter selection criteria.

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

(7)

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 symptoms (i.e., reduction of FI episodes; improved control 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 parameters (i.e., manometric; electrophysiologic; ultrasonographic).

Conceptually, considering a good response as an improvement of at least 50% in FI could be debatable. 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 clinical parameters to define treatment response, available 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 reflecting 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 single parameter is considered because of the multifactorial origin of FI. Moreover, the influence of a particular treatment could be different in different subgroups 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 techniques and results, as well as the pros and cons of using each approach.

References

1. Ternent CA, Shashidharan M, Blatchford GJ et al (1996) Do anorectal physiology tests result in altered therapy for fecal incontinence? Gastroenterology 110:A43

2. Liberman H, Faria J, Ternent CA et al (2001) A prospective evaluation of the value of anorectal physiology in the management of fecal incontinence. Dis Colon Rectum 44:1567–1574

3. Keating JP, Stewart PJ, Eyers AA et al (1997) Are spe- cial investigations of value in the management of patients with fecal incontinence? Dis Colon Rectum 40:896–901

4. Rao SS, Patel RS (1997) How useful are manometric tests of anorectal function in the management of defecation disorders? Am J Gastroenterol 92:469–475 5. Speakman CT, Henry MM (1992) The work of an

anorectal physiology laboratory. Baillieres Clin Gas- troenterol 6:59–73

6. Wexner SD, Jorge JM (1994) Colorectal physiological tests: use or abuse of technology? Eur J Surg 160:167–174

7. Norton C, Kamm MA (2001) Anal sphincter biofeedback and pelvic floor exercises for faecal incontinence in adults. Aliment Pharmacol Ther 15:1147–1154 8. Whitehead W, Wald A, Norton J (2001) Treatment

options for fecal incontinence. Dis Colon Rectum 44:

131–144

9. Cerulli MA, Nikoomanesh P, Schuster MM (1979) Progress in biofeedback conditioning for fecal incontinence. Gastroenterology 76:742–746

10. Wald A (1981) Biofeedback therapy for fecal incontinence. Ann Intern Med 95:146–149

11. Sangwan YP, Coller JA, Barrett RC et al (1995) Can manometric parameters predict response to biofeedback therapy in fecal incontinence? Dis Colon Rectum 38:1021–1025

12. Fernandez-Fraga X, Azpiroz F, Aparici A et al (2003) Predictors of response to biofeedback treatment in anal incontinence. Dis Colon Rectum 46:1218–1225 13. Rieger NA, Wattchow DA, Sarre RG et al (1997)

Prospective trial of pelvic floor retraining in patients with fecal incontinence. Dis Colon Rectum 40:821–826 14. Chiarioni G, Bassotti G, Stegagnini S et al (2002) Sen- sory retraining is key to biofeedback therapy for formed stool fecal incontinence. Am J Gastroenterol 97:109–117

15. Rao SS, Welcher KD, Happel J (1996) Can biofeedback therapy improve anorectal function in fecal incontinence? Am J Gastroenterol 91:2360–2366

16. Bharucha AE (2003) Fecal incontinence. Gastroen- terology 124: 1672–1685

17. Buser WD, Miner PB Jr (1986) Delayed rectal sensation with fecal incontinence. Successful treatment

(8)

using anorectal manometry. Gastroenterology 91:

1186–1191

18. Sun WM, Read NW, Miner PB (1990) Relation between rectal sensation and anal function in normal subjects and patients with fecal incontinence. Gut 31:807–813 19. Leroi AM, Dorival MP, Lecouturier MF et al (1999)

Pudendal neuropathy and severity of incontinence but not presence of an anal sphincter defect may determine the response to biofeedback therapy in fecal incontinence. Dis Colon Rectum 42:762–769

20. Laurberg S, Swash M, Snooks SJ, Henry MM (1988) Neurologic cause of idiopathic incontinence. Arch Neurol 45:1250–1253

21. Wexner SD, Marchetti F, Jagelman DG (1991) The role of sphincteroplasty for fecal incontinence re-evaluated: a prospective physiologic and functional review.

Dis Colon Rectum 34:22–30

22. Oliveira L, Pfeifer J, Wexner SD (1996) Physiological and clinical outcome of anterior sphincteroplasty. Br J Surg 83:502–505

23. Gilliland R, Altomare DF, Moreira H Jr et al (1998) Pudendal neuropathy is predictive of failure following anterior overlapping sphincteroplasty. Dis Colon Rec- tum 41:1516–1522

24. Londono-Schimmer EE, Garcia-Duperly R, Nicholls RJ et al (1994) Overlapping anal sphincter repair for faecal incontinence due to sphincter trauma: five year follow-up functional results. Int J Colorectal Dis 9:110–113

25. Sangwan YP, CollerJA, Barrett RC et al (1996) Unilat- eral pudendal neuropathy. Impact on outcome of anal sphincter repair. Dis Colon Rectum 39:686–689 26. Sitzler PJ, Thomson JPS (1996) Overlap repair of dam-

aged anal sphincter. A single surgeon’s series. Dis Colon Rectum 39:1356–1360

27. Nikiteas N, Korsgen S, Kumar D, Keighley MRB (1996) Audit of sphincter repair. Factors associated with poor outcome. Dis Colon Rectum 39:1164–1170

28. Rasmussen OO, Colstrup H, Lose G, Christiansen J (1990) A technique for the dynamic assessment of anal sphincter function. Int J Colorectal Dis 5:135–141 29. Young CJ, Mathur MN, Eyers AA, Solomon MJ (1998)

Successful overlapping anal sphincter repair: relation- ship to patient age, neuropathy and colostomy formation. Dis Colon Rectum 41:344–349

30. Chen AS, Luchtefeld MA, Senagore AJ et al (1998) Pudendal nerve latency. Does it predict outcome of anal sphincter repair? Dis Colon Rectum 41:1005–1009 31. Buie WD, Lowry AC, Rothenberger DA, Madoff RD (2001) Clinical rather than laboratory assessment pre- dicts continence after anterior sphincteroplasty. Dis Colon Rectum 44:1255–1260

32. Halverson AL, Hull TL (2002) Long-term outcome of overlapping anal sphincter repair. Dis Colon Rectum 45:345–348

33. Bravo Gutierrez A, Madoff RD, Lowry AC et al (2004) Long-term results of anterior sphincteroplasty. Dis Colon Rectum 47:727–731

34. Trowbridge ER, Morgan D, Trowbridge MJ et al (2006) Sexual function, quality of life, and severity of anal incontinence after anal sphincteroplasty. Am J Obstet Gynecol 195:1753–1757

35. Steele SR, Lee P, Mullenix PS et al (2006) Is there a role

for concomitant pelvic floor repair in patients with sphincter defects in the treatment of fecal incontinence? Int J Colorectal Dis 21:508–514

36. Evans C, Davis K, Kumar D (2006) Overlapping anal sphincter repair and anterior levatorplasty: effect of patient's age and duration of follow-up. Int J Colorec- tal Dis 21:795–801

37. Vaizey CJ, Kamm MA, Nicholls RJ (1998) Recent advances in the surgical treatment of faecal incontinence. Br J Surg 85:596–603

38. Athanasiadis S, Sanchez M, Kuprian A (1995) Long - term follow-up of Parks posterior repair. An elec- tromyographic, manometric and radiologic study of 31 patients. Langenbeck Arch Chir 380:22–30 39. Rockwood TH, Church JM, Fleshman S et al (1999)

Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index. Dis Colon Rectum 42:1525–1531

40. Rockwood TH, Church JM, Fleshman JW (2000) Fecal incontinence quality of life scale. Dis Colon Rectum 43:10–16

41. Korsgen S, Keighley MRB (1995) Stimulated gracilis neosphincter-not as good as previously thought.

Report of four cases. Dis Colon Rectum 38:1331–1333 42. Baeten CG, Geerdes BP, Adang EM et al (1995) Anal dynamic graciloplasty in the treatment of intractable fecal incontinence. N Engl J Med 332:1600–1605 43. Koch SM, Uludag O, Rongen MJ et al (2004) Dynamic

graciloplasty in patients born with an anorectal mal- formation. Dis Colon Rectum 47:1711–1719

44. Geerdes BP, Heineman E, Konsten J et al (1996) Dynamic graciloplasty. Complications and management. Dis Colon Rectum 39:912–917

45. Wexner SD, Gonzalez-Padron A, Rius J et al (1996) Stimulated gracilis neosphincter operation. Initial experience, pitfalls, and complications. Dis Colon Rec- tum 39(9):957–964

46. Baeten CG, Bailey HR, Bakka A et al (2000) Safety and efficacy of dynamic graciloplasty for fecal incontinence: report of a prospective, multicenter trial Dynamic Graciloplasty Therapy Study Group. Dis Colon Rectum 43:743–751

47. Rongen MJ, Uludag Ö, El Naggar K et al (2003) Long- term follow-up of dynamic graciloplasty for faecal incontinence. Dis Colon Rectum 46:716–721

48. Lehur PA, Michot F, Denis P et al (1996) Results of artificial sphincter in severe anal incontinence. Report of 14 consecutive implantations. Dis Colon Rectum 39:1352–1355

49. Lehur PA, Zerbib F, Glemain P et al (2002) Compari- son of quality of life and anorectal function after artificial sphincter implantation. Dis Colon Rectum 45:508–513

50. Parker SC, Spencer MP, Madoff RD (2003) Artificial bowel sphincter: long-term experience at a single institution. Dis Colon Rectum 46:722–729

51. O'Brien PE, Dixon JB, Skinner S et al (2004) A prospective randomised controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphinc- ter) for the control of fecal incontinence. Dis Colon Rectum 47(11):1852–1860

52. Mundy L, Merlin TL, Maddern GJ, Hiller JE (2004) Sys-

(9)

tematic review of safety and effectiveness of an artificial bowel sphincter for faecal incontinence. Br J Surg 91:665–672

53. Michot F, Costaglioli B, Leroi AM, Denis P (2003) Arti- ficial anal sphincter in severe fecal incontinence: outcome of prospective experience with 37 patients in one institution. Ann Surg 237:52–56

54. Bruining HA, Bos KE, Colthoff EG et al (1981) Cre- ation of an anal sphincter mechanism by bilateral proximally based gluteal muscle transposition. Plast Reconstr Surg 67:70–72

55. Guelinckx PJ, Sinsel NK, Gruwez JA (1996) Anal sphincter reconstruction with the gluteus maximus muscle: anatomic and physiologic considerations concerning conventional and dynamic gluteoplasty. Plast Reconstr Surg 98:293–302

56. Hultman CS, Zenn MR, Agarwal T et al (2006) Restora- tion of fecal continence after functional gluteoplasty:

Long-term results, technical refinements, and donor- site morbidity. Ann Plast Surg 56:65–71

57. Matzel KE, Stadelmaier U, Hohenfellner M et al (1994) Electrical stimulation of sacral spinal nerves for treatment of faecal incontinence. Lancet 346:1124–1127 58. Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP

(1995) Electrical stimulation for the treatment of faecal incontinence. Lancet 346:1124–1127

59. Matzel KE (2001) Sacral spinal nerve stimulation in treatment of fecal incontinence. Semin Colon Rectal Surg 12:121–130

60. Leroi AM, Michot F, Grise P, Denis P (2001) Effect of sacral nerve stimulation in patients with fecal and urinary incontinence. Dis Colon Rectum 44:779–789 61. Ganio E, Ratto C, Masin A et al (2001) Neuromodula-

tion for fecal incontinence: outcome in 16 patients with definitive implant. The initial Italian Sacral Neu- rostimulation Group (GINS) experience. Dis Colon Rectum 44:965–970

62. Matzel KE, Stadelmaier U, Hohenberger W (2004) Innovations in fecal incontinence: Sacral nerve stimulation. Dis Colon Rectum 47:1720–1728

63. Matzel KE, Kamm MA, Stösser M et al MDT 301 Study Group (2004) Sacral nerve stimulation for fecal incontinence: a multicenter study. Lancet 363:1270–1276 64. Tjandra JJ, Lim JF, Matzel KE (2004) Sacral nerve stim-

ulation – an emerging treatment for faecal incontinence. ANZ J Surg 74:1098–1106

65. Rosen HR, Urbarz C, Holzer B et al (2001) Sacral nerve stimulation as a treatment for fecal incontinence. Gas- troenterology 121:536–541

66. Malouf AJ, Vaizey CJ, Nicholls RJ, Kamm MA (2000) Permanent sacral nerve stimulation for faecal incontinence. Ann. Surg 232:143–148

67. Ganio E, Realis Luc A, Ratto C et al (2003) Sacral nerve modulation for fecal incontinence: functional results and assessment of the quality of life. http://www.col- orep.it/Rivista%20CEC/sacral_nerve_modulation_for _feca.htm. Cited 28 Nov 2005

68. Jarrett ME, Varma JS, Duthie GS et al (2004) Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg 91:755–761

69. Bernstein AJ, Peters KM (2005) Expanding indications for neuromodulation. Urol Clin North Am 32:59–63 70. Jarrett ME, Matzel KE, Christiansen J et al (2005)

Sacral nerve stimulation for faecal incontinence in patients with previous partial spinal injury including disc prolapse. Br J Surg 92:734–739

71. Kenefick NJ, Vaizey CJ, Nicholls RJ et al (2002) Sacral nerve stimulation for faecal incontinence due to sys- temic sclerosis. Gut 51:881–883

72. Leroi AM, Michot F, Grise P, Denis P (2001) Effect of sacral nerve stimulation in patients with faecal and urinary incontinence. Dis Colon Rectum 44:779–789 73. Jarrett ME, Matzel KE, Stosser M et al (2005) Sacral

nerve stimulation for fecal incontinence following surgery for rectal prolapse repair: a multicenter study. Dis Colon Rectum 48:1243–1248

74. Matzel KE, Stadelmaier U, Bittorf B et al (2002) Bilat- eral sacral spinal nerve stimulation for fecal incontinence after low anterior rectum resection. Int J Col- orectal Dis 17:430–434

75. Uludag O, Dejong HC (2002) Sacral neuromodulation for faecal incontinence. Dis Colon Rectum 45:34–36 76. Matzel KE, Bittorf B, Stadelmaier U, Hohenberger W

(2003) Sacral nerve stimulation in the treatment of faecal incontinence. Chirurg 74:26–32

77. Ratto C, Grillo E, Parello A et al (2005) Sacral neuromodulation in treatment of fecal incontinence following anterior resection and chemoradiation for rectal cancer. Dis Colon Rectum 48:1027–1036

78. Jarrett ME, Matzel KE, Stosser M et al (2005) Sacral nerve stimulation for faecal incontinence following a rectosigmoid resection for colorectal cancer. Int J Col- orectal Dis 20:446–451

79. Ratto C, Petrolino M, Altomare DF et al (2004) The effects of sacral neuromodulation on rectal sensation can predict improvement of fecal incontinence. Dis Colon Rectum 47:611

80. Rosen H (2004) SNS-How does it work. Proceedings from Meeting of European Association of Coloproc- tology, Geneva

81. Braun PM, Baezner H, Seif C et al (2002) Alterations of cortical electrical activity in patients with sacral neu- romodulator. Eur Urol 41:562–566

82. Malaguti S, Spinelli M, Giardiello G et al (2003) Neu- rophysiological evidence may predict the outcome of sacral neuromodulation. J Urol 170:2323–2326 83. Gourcerol G, Gallas S, Michot F et al (2007) Sacral

nerve stimulation in fecal incontinence: are there factors associated with success? Dis Colon Rectum 50:3–12 84. Vaizey CJ, Kamm MA (2005) Injectable bulking agents for treating faecal incontinence. Br J Surg 92:521–527 85. Efron JE, Corman ML, Fleshman J et al (2003) Safety

and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca procedure) for the treatment of fecal incontinence. Dis Colon Rectum 46:1606–1616

86. Takahashi T, Garcia-Osogobio S, Valdovinos MA et al (2003) Extended two-year results of radio-frequency energy delivery for the treatment of fecal incontinence (the Secca procedure). Dis Colon Rectum 46:711–715 87. Efron JE (2004) The SECCA procedure: a new therapy

for treatment of fecal incontinence. Surg Technol Int 13:107–110

88. Ratto C, Parello A, Donisi L (2007) Sacral Neuromod- ulation in the treatment of defecation disorders. Acta Neurochir 97 (Suppl) 341–350