5. Discussions and literature review

The main limit of our study is the reduced number of patients who accepted the program of anorectal biofeedback. On the other hand, we have to accept that the study was performed in the single center of this country performing this kind of management of defecation disorders. The indications for biofeedback are relatively scarce, and for some patients, there are no obvious early results, thus discouraging patients to continue next sessions. A success factor is the motivation of the patient, leading to increased adherence, and not all of possible patients are indeed motivated. Other patients refuse because they would have to travel long distance to the biofeedback laboratory. Our center is also very busy with usual manometric investigations; therefore, time left for biofeedback is reduced also from our side. But even in these conditions, our center is one of the few in East Europe working on anorectal biofeedback. Therapeutic results are important for the patients mainly in functional anal incontinence, but also for terminal constipation. The maintenance of the outcome in terminal constipation after the finishing of the biofeedback sessions is modest, and relapses have been described after the end of the interventions [19].

Better results are observed in the functional anal incontinence and almost nil in organic anal incontinence. About 70% of cases positively respond to biofeedback but there are not predictive criteria to predict well the outcome of anorectal biofeedback in incontinence. Nor in functional incontinence are the results perfect, even if carried out in supervised laboratories. At the end of therapy, relapse can occur in up of one quarter of cases with fecal incontinence. The relationship between the operator and the patient is very important for success of failure, given the very intimate character of this procedure. Lack of appropriate behavior or of empathy will lead to failure. Lack of adherence is another failure factor. Female patients respond better than males, also possibly because the nurses/technicians working in the biofeedback laboratories are of the same gender [20–23]. The complexity of the physiological phenomena involved in defecation renders the therapeutic approach by biofeedback a difficult task. We consider that not all executor muscles can be involved in exercises. As severe the motor alterations are, as difficult is to expect a favorable outcome.

telephone intervention, there is no additional effect on incontinence but patients' satisfaction is higher. Unlike in our area, where living on country side is associated with withdrawing from the biofeedback program because of logistic issues, in this UK study it seems that living in rural area does not influence the outcome of biofeedback. This study is continuing an attempt which was published more than 10 years earlier [28]. In this older study, an attempt to evaluate and validate the interaction with the patient beside the technical procedure only was made. Biofeedback is an effective treatment for patients with fecal incontinence, yet little is known about how it works or the minimum regime necessary to provide clinical benefit. This study compares the effectiveness of a novel protocol of telephone-assisted biofeedback treatment for patients living in rural and remote areas with the standard face-to-face protocol for patients with fecal incontinence. The authors have created a strategy based on the offer of an initial face-to-face assessment before the standard anorectal biofeedback procedure; telephone interview to guide distance living subjects with biofeedback was also used. This strategy was compared with the standard intervention based on manometry, using an ultrasonographic signal for biofeedback. The study included more than 200 participants. More than 70% of them completed the treatment. From these, in more than 50% of cases, the patient rated themselves an improvement; the observers rated in more than three quarters of cases positive results in respect to fecal incontinence and quality of life. Nor in this case was the use of telephone

Factors Predicting Failure in Anorectal Biofeedback http://dx.doi.org/10.5772/intechopen.76374 31

All these studies underline the long way from the beginning of the use of biofeedback for fecal incontinence and terminal constipation (dyssynergia). Not more than 10 years ago, systematic reviews of the methods were not able to find relevant and well conducted studies nor definitive conclusions. Thus, the Cochrane Review of 2006 looked for biofeedback interventions on fecal incontinence [29]. The collaborative group was only able to find out 11 eligible studies, including only over 550 subjects. Most trials presented methodological shortcomings, thus having conclusions that could not be accepted without reserves. In no paper could be reported any major improvement of outcome between any biofeedback procedure versus the standard non-biofeedback therapy. The Cochrane group considered the anorectal biofeedback superior to vaginal biofeedback in females with obstetrical history predisposing to incontinence. Thus, the authors concluded that the number of studies (at that time) was insufficient and the quality of most of them not good enough to warrant the use of biofeedback for incontinence. One year later, a British showed a similar reservation versus the biofeedback [30]. In 2012, another Cochrane report [31] dedicated to therapy of fecal incontinence was able to bring much better evidence. This time, the Cochrane collaborative group found 21 eligible studies including more than 1500 subjects. The quality of the studies was better. Some small studies showed the advantage to add exercises or electrostimulation of the sphincter to biofeedback. This time the newer method of sacral nerve stimulation was considered superior to conservative and biofeedback management. The authors were not very happy with the number of studies found, although its number was increased. The effect of biofeedback was inferior to nerve stimulation

[31]. Of course, the outcome depends very much on the etiology of incontinence [1].

Anorectal biofeedback has its application also in pediatric patients. There are several papers reporting its effect on children [32–37]. From older studies with less enthusiastic data [33], now we have enough evidence on the benefits of anorectal biofeedback in children with fecal

superior to the standard intervention.

#### 5.1. The experience of other centers on anorectal biofeedback

In recent years, a number of useful papers have been published on this field, increasing the evidence on the use of anorectal biofeedback for anal incontinence and for terminal constipation. These titles complete the corpus of references accumulated in the last 30 years. A PubMed search using keywords anorectal biofeedback renders more than 400 titles. This shows the interest of the investigators on this topic.

A major paper recently published is the French consensus on therapy of chronic constipation, written by the National Coloproctology Society of France [24]. This working group arrived to a consensus stating that anorectal biofeedback should represent the gold standard for the therapy of anorectal dyssynergia, but only if no response to medical treatment can be observed. This consensus emphasized thus the role of biofeedback treatment of anorectal disorders, situation it as a second line intervention, given the ponderous characteristics of this procedure. In the author's recent review, the shortcoming of HRM in the diagnosis of anorectal disorders is described, while anorectal biofeedback is perceived as a useful tool for terminal constipation caused by dyssynergia. The effect of biofeedback training is explained by central effects. However, baseline manometric data do not predict yet the outcome of biofeedback therapy [25]. Unlike in our study, the author did not consider the role of logistical difficulty cause by distance from the venue of the biofeedback and manometry laboratory.

Another recent work coming from the very active and expert group around Satish Rao [26] evaluated the factors associated with response to biofeedback in anorectal dyssynergia. On a much larger group than our group, containing more than 120 subjects in a post-hoc analysis, the authors showed that anorectal biofeedback improved in more than 60% of the cases the terminal constipation and three quarters of them presented a correction of the dyssynergia. However, there were few predictive factors for success or failure, as either demographic characteristics of the patients or the severity of constipation and manometric baseline data did not differ between the successful and failure cases. Single differences were recorded in respect to satisfaction: lower scores in those who improved and in the used of digital expulsion, maneuver which predicted success. It means that expectancy and difficulty of expulsion are associated with better effect of the biofeedback therapy [26]. Anorectal biofeedback may be performed according to different strategic steps, depending on the experience of each center. But we still need comparative studies to decide which technique is more performing. An attempt to find out which technique is superior was undertaken in a recent study [27]. In St. Marks Hospital, a randomized trial in four groups of anal incontinence was organized. Two groups of patients with incontinence were created according to the living area: urban or rural; each group was further subdivided into two subgroups: one included face-to-face interaction, while the other included telephonic interaction. The therapy lasted 4 months and showed improvement by biofeedback of incontinence, of psychological factors: that is, anxiety and depression, of quality of life, and of manometric data. This study carried out on 350 subjects showed that adding to the procedure of biofeedback an interaction either by face-to-face or by telephone intervention, there is no additional effect on incontinence but patients' satisfaction is higher. Unlike in our area, where living on country side is associated with withdrawing from the biofeedback program because of logistic issues, in this UK study it seems that living in rural area does not influence the outcome of biofeedback. This study is continuing an attempt which was published more than 10 years earlier [28]. In this older study, an attempt to evaluate and validate the interaction with the patient beside the technical procedure only was made. Biofeedback is an effective treatment for patients with fecal incontinence, yet little is known about how it works or the minimum regime necessary to provide clinical benefit. This study compares the effectiveness of a novel protocol of telephone-assisted biofeedback treatment for patients living in rural and remote areas with the standard face-to-face protocol for patients with fecal incontinence. The authors have created a strategy based on the offer of an initial face-to-face assessment before the standard anorectal biofeedback procedure; telephone interview to guide distance living subjects with biofeedback was also used. This strategy was compared with the standard intervention based on manometry, using an ultrasonographic signal for biofeedback. The study included more than 200 participants. More than 70% of them completed the treatment. From these, in more than 50% of cases, the patient rated themselves an improvement; the observers rated in more than three quarters of cases positive results in respect to fecal incontinence and quality of life. Nor in this case was the use of telephone superior to the standard intervention.

consider that not all executor muscles can be involved in exercises. As severe the motor

In recent years, a number of useful papers have been published on this field, increasing the evidence on the use of anorectal biofeedback for anal incontinence and for terminal constipation. These titles complete the corpus of references accumulated in the last 30 years. A PubMed search using keywords anorectal biofeedback renders more than 400 titles. This shows the

A major paper recently published is the French consensus on therapy of chronic constipation, written by the National Coloproctology Society of France [24]. This working group arrived to a consensus stating that anorectal biofeedback should represent the gold standard for the therapy of anorectal dyssynergia, but only if no response to medical treatment can be observed. This consensus emphasized thus the role of biofeedback treatment of anorectal disorders, situation it as a second line intervention, given the ponderous characteristics of this procedure. In the author's recent review, the shortcoming of HRM in the diagnosis of anorectal disorders is described, while anorectal biofeedback is perceived as a useful tool for terminal constipation caused by dyssynergia. The effect of biofeedback training is explained by central effects. However, baseline manometric data do not predict yet the outcome of biofeedback therapy [25]. Unlike in our study, the author did not consider the role of logistical difficulty cause by

Another recent work coming from the very active and expert group around Satish Rao [26] evaluated the factors associated with response to biofeedback in anorectal dyssynergia. On a much larger group than our group, containing more than 120 subjects in a post-hoc analysis, the authors showed that anorectal biofeedback improved in more than 60% of the cases the terminal constipation and three quarters of them presented a correction of the dyssynergia. However, there were few predictive factors for success or failure, as either demographic characteristics of the patients or the severity of constipation and manometric baseline data did not differ between the successful and failure cases. Single differences were recorded in respect to satisfaction: lower scores in those who improved and in the used of digital expulsion, maneuver which predicted success. It means that expectancy and difficulty of expulsion are associated with better effect of the biofeedback therapy [26]. Anorectal biofeedback may be performed according to different strategic steps, depending on the experience of each center. But we still need comparative studies to decide which technique is more performing. An attempt to find out which technique is superior was undertaken in a recent study [27]. In St. Marks Hospital, a randomized trial in four groups of anal incontinence was organized. Two groups of patients with incontinence were created according to the living area: urban or rural; each group was further subdivided into two subgroups: one included face-to-face interaction, while the other included telephonic interaction. The therapy lasted 4 months and showed improvement by biofeedback of incontinence, of psychological factors: that is, anxiety and depression, of quality of life, and of manometric data. This study carried out on 350 subjects showed that adding to the procedure of biofeedback an interaction either by face-to-face or by

alterations are, as difficult is to expect a favorable outcome.

interest of the investigators on this topic.

30 Biofeedback

5.1. The experience of other centers on anorectal biofeedback

distance from the venue of the biofeedback and manometry laboratory.

All these studies underline the long way from the beginning of the use of biofeedback for fecal incontinence and terminal constipation (dyssynergia). Not more than 10 years ago, systematic reviews of the methods were not able to find relevant and well conducted studies nor definitive conclusions. Thus, the Cochrane Review of 2006 looked for biofeedback interventions on fecal incontinence [29]. The collaborative group was only able to find out 11 eligible studies, including only over 550 subjects. Most trials presented methodological shortcomings, thus having conclusions that could not be accepted without reserves. In no paper could be reported any major improvement of outcome between any biofeedback procedure versus the standard non-biofeedback therapy. The Cochrane group considered the anorectal biofeedback superior to vaginal biofeedback in females with obstetrical history predisposing to incontinence. Thus, the authors concluded that the number of studies (at that time) was insufficient and the quality of most of them not good enough to warrant the use of biofeedback for incontinence. One year later, a British showed a similar reservation versus the biofeedback [30]. In 2012, another Cochrane report [31] dedicated to therapy of fecal incontinence was able to bring much better evidence. This time, the Cochrane collaborative group found 21 eligible studies including more than 1500 subjects. The quality of the studies was better. Some small studies showed the advantage to add exercises or electrostimulation of the sphincter to biofeedback. This time the newer method of sacral nerve stimulation was considered superior to conservative and biofeedback management. The authors were not very happy with the number of studies found, although its number was increased. The effect of biofeedback was inferior to nerve stimulation [31]. Of course, the outcome depends very much on the etiology of incontinence [1].

Anorectal biofeedback has its application also in pediatric patients. There are several papers reporting its effect on children [32–37]. From older studies with less enthusiastic data [33], now we have enough evidence on the benefits of anorectal biofeedback in children with fecal incontinence or encopresis, or respectively with anismus. The problem of the pediatric investigation is the reduced collaboration with small children. On the other hand, there are devices allowing to perform biofeedback at home.

prospective study. International Journal of Radiation Oncology, Biology, Physics. 2005;

Factors Predicting Failure in Anorectal Biofeedback http://dx.doi.org/10.5772/intechopen.76374 33

[6] Jayarajah U, Wickramasinghe DP, Samarasekera DN. Anal incontinence and quality of life following operative treatment of simple cryptoglandular fistula-in-ano: A prospective study. BMC Research Notes. 2017;10(1):572. DOI: 10.1186/s13104-017-2895-z. PMID:

[7] Long-term bowel function, quality of life and sexual function in patients with anorectal malformations treated during the PSARP era. Seminars in Pediatric Surgery. 2017;26(5):

[8] Dujovny N, Quiros RM, Saclarides TJ. Anorectal anatomy and embryology. Surgical

[9] Rao SS, Benninga MA, Bharucha AE, Chiarioni G, Di Lorenzo C, Whitehead WE. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterology and Motility. 2015;27(5):594-609. DOI: 10.1111/nmo.12520 [10] Patcharatrakul T, Rao SSC. Update on the pathophysiology and Management of Anorectal

[11] Schmulson MJ, Drossman DA. What is new in Rome IV. Journal of Neurogastroenterology

[12] Chira A, Dumitrascu DL. Validation of the Bristol stool form scale into Romanian. Journal

[13] Camilleri M, Ford AC, Mawe GM, Dinning PG, Rao SS, Chey WD, Simrén M, Lembo A, Young-Fadok TM, Chang L. Chronic constipation. Nature Reviews Disease Primers. 2017

[14] Chaussade S, Roche H, Khyari A, Couturier D, Guerre J. Mesure du temps de transit colique (TTC): description et validation d'une nouvelle technique. [Measurement of colonic transit time: description and validation of a new method]. Gastroentérologie

[15] Zerbib F, Dapoigny M. Les Explorations Fonctionnelles Digestives. 1st ed. Elsevier Mas-

[16] Yeap ZH, Simillis C, Qiu S, Ramage L, Kontovounisios C, Tekkis P. Diagnostic accuracy of anorectal manometry for fecal incontinence: A meta-analysis. Acta Chirurgica Belgica.

[17] Brochard C, Peyronnet B, Dariel A, Ménard H, Manunta A, Ropert A, Neunlist M, Bouguen G, Siproudhis L. Bowel dysfunction related to Spina bifida: Keep it simple. Diseases of the

[18] Weber J, Ducrotte P, Touchais JY, Roussignol C, Denis P. Biofeedback training for constipation in adults and children. Diseases of the Colon and Rectum. 1987;30:844-846

Colon and Rectum. 2017;60(11):1209-1214. DOI: 10.1097/DCR.0000000000000892

336-342. DOI: 10.1053/j.sempedsurg.2017.09.010

Disorders. Gut Liver. 2017. DOI: 10.5009/gnl17172

Dec 14;3:17095. DOI: 10.1038/nrdp.2017.95

Clinique et Biologique. 1986;10(5):385-389

and Motility. 2017;23(2):151-163. DOI: 10.5056/jnm16214

2017;117(6):347-355. DOI: 10.1080/00015458.2017.1394674

of Gastrointestinal and Liver Diseases. 2015 Dec;24(4):539-540

Oncology Clinics of North America. 2004 Apr;13(2):277-293

61(4):1129-1135

29115980

son; 2010

The role of biofeedback in different applications has been recently emphasized by the fourth edition of the textbook of Schwartz and Andrasik [38].
