Anal sphincter deficiency: clinical guidelines

List of Abbreviations

AI – anal incontinence

ACR – Association of Coloproctologists of Russia

CD – Crohn's disease

BF — biofeedback

BEA – bioelectric activity

IBD - inflammatory bowel disease

ZAPK — sphincter apparatus of the rectum

PFM – pelvic floor muscles

IAS – anal sphincter insufficiency

RAIR — rectoanal inhibitory reflex

PFDS — Pelvic floor descent syndrome

PF – pelvic floor

Ultrasound — ultrasound examination

FDD – functional defecation disorders

EMG - electromyography

ENMG – electroneuromyography

UC – ulcerative colitis

Terms and Definitions

Gluteoplasty – creation of the anal sphincter using long flaps of the gluteus maximus muscle.

Gracilis muscle transposition – creation of the anal sphincter using the gracilis muscle of the thigh.

Sphincterogluteoplasty – replacement of an external anal sphincter defect with a short flap of the gluteus maximus muscle.

1. Brief information on the disease or condition

1.1 Definition of the disease or condition

Anal sphincter insufficiency (ASI) is a partial or complete impairment of voluntary and involuntary retention of intestinal contents [1].

Synonyms: anal incontinence, bowel incontinence, fecal incontinence.

1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)

The function of bowel content retention depends on a coordinated combination of various factors: geometric, elastic, and closure properties of the anal sphincters; the state of the anorectal angle; the motor and evacuation activity of the colon; the interaction of the rectal and anal canal receptor apparatus, nerve conduction pathways, spinal cord and brain with the muscular structures of the internal and external sphincters; and the volume and consistency of intestinal contents. However, the primary role in fecal retention belongs to the anal sphincter system – the anal sphincter apparatus (ASA) [2].

In women, one of the most common causes of anal incontinence (AI) is childbirth: AI may develop either after traumatic rupture of the anal sphincter muscle structures, which statistically occurs in 3.5 – 8% of vaginal deliveries [3], or as a result of nerve fiber damage responsible for the innervation of the ASA. This is supported by data from a large-scale study including examination results of over 4,000 women, which established that symptoms of anal sphincter insufficiency were recorded in 23.4% of cases after spontaneous vaginal delivery and in 18.9% after cesarean section [4]. Thus, it has been established that cesarean section cannot completely rule out the development of anal incontinence.

In 34% of cases, surgical interventions for rectal fistulas are also accompanied by the development of postoperative anal sphincter insufficiency [5], which is often due to damage to a large volume of sphincter muscle fibers or the development of purulent complications [6]. Postoperative ASI also occurs after surgical interventions for chronic anal fissure (sphincterotomy) and chronic combined hemorrhoids stages 3–4 (hemorrhoidectomy). The incidence of anal sphincter insufficiency following various household injuries of the distal rectum and perineum ranges from 10% to 25% among all types of post-traumatic ASI.

The second most frequent is functional ASI, which develops as a result of disorders in ASA activity associated with diseases of the peripheral or central nervous system.

In third place are various congenital malformations of the anorectal region, which in most cases are accompanied by symptoms of anal sphincter insufficiency. Among this category of patients, those with complete anal incontinence are most common. They require complex, staged surgical treatment more often than others.

1.3 Epidemiology of the Disease or Condition

Incontinence of various components of intestinal contents is a fairly common phenomenon, but its true incidence is quite difficult to estimate. This is primarily facilitated by the psychoemotional state of patients and their desire to hide the presence of this problem due to negative social attitudes [7]. The fact that people conceal periodically occurring episodes of incontinence makes it difficult to assess the true prevalence of ASI in the general population. Thus, an objective count of patients suffering from anal incontinence is possible only if they are examined and treated in specialized hospitals or nursing homes. According to data from the United States National Health and Nutrition Examination, obtained from the examination of 14,759 patients, the prevalence of fecal incontinence averaged 8.4%, with an increased incidence found in patients over 70 years of age [8]. Up to 50% of nursing home residents suffer from ASI [9]. According to international population-based studies, the prevalence of anal incontinence ranges from 0.4% to 18% [10]. Approximately 1 in 12 adults worldwide experiences anal incontinence, with a higher prevalence among women and the elderly [11].

1.4 Features of Coding the Disease or Condition

ICD-10 Codes

Class - Diseases of the digestive system (XI):

Block – Other diseases of intestine (K62).

K62.8 Other specified diseases of anus and rectum.

OR

Class – Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified (R00-R99):

Block – Symptoms and signs involving the digestive system and abdomen (R10-R19).

R15 Fecal incontinence.

1.5 Classification of the disease or condition

Classification of ASI by form [1]:

· organic;

· non-organic (functional);

· mixed.

Organic ASI, depending on etiology, is classified into the following types [1]:

· post-traumatic;

· postoperative;

· postpartum;

· congenital.

Classification by degree of bowel content incontinence (impairment of retention function) [1]:

· Grade 1 – gas incontinence;

· Grade 2 – gas and liquid stool incontinence;

· Grade 3 – gas, liquid, and solid stool incontinence.

Explanatory notes to the classification of anal sphincter insufficiency.

Various classifications of anal sphincter insufficiency exist to assess the severity of incontinence. Currently, in clinical practice, the aforementioned classification subdividing anal sphincter insufficiency by form, etiology, and degree of bowel content incontinence is of greater importance; however, when choosing a treatment method, categorizing ASI based on clinical-functional and morphological changes of the anal sphincter can be of considerable significance.

1.6 Clinical presentation of the disease or condition

The main clinical manifestation of anal sphincter insufficiency is the inability to retain various components of intestinal contents – gas and/or liquid stool and/or solid stool.

Patients with anal incontinence may also present with complaints of fecal smearing, as well as the inability to retain rectal contents until reaching a socially acceptable location (toilet) [1, 12].

2. Diagnostics, medical indications and contraindications for diagnostic methods

The criteria for establishing the diagnosis of "anal sphincter insufficiency" are:

1. Patient complaints of incontinence of one or more components of intestinal contents.

2. Objective data on the functional preservation of the muscular structures of the ASA (assessment of anal sphincter apparatus function via sphincterometry).

3. Objective data on the structural integrity of the ASA (transrectal ultrasound of the rectum).

In most cases, establishing a diagnosis of anal sphincter insufficiency requires patient history, clinical evaluation, and the instrumental studies listed above.

Principles of formulation of the diagnosis.

When formulating the diagnosis of anal sphincter insufficiency, the etiology, form, and grade of the disease should be indicated. Examples of diagnosis formulation are given below:

1. "Post-traumatic anal sphincter insufficiency, grade 2".

2. "Functional anal sphincter insufficiency, grade 3".

2.1 Complaints and Anamnesis

Anal sphincter insufficiency is characterized by complaints of incontinence regarding specific components of intestinal contents and their severity.

Taking a medical history is primarily aimed at identifying etiological factors contributing to the onset of the disease:

· congenital diseases of the anorectal zone;

· gastrointestinal disorders;

· diet and eating habits;

· stool consistency;

· history of inflammatory bowel disease (IBD) – ulcerative colitis (UC) or Crohn's disease (CD);

· neurological disorders, including prior neurosurgical interventions;

· obstetric history, including the number of deliveries, nature of labor (precipitate labor, instrumental delivery, etc.), labor complications (perineal tears, episiotomy, etc.);

· history of previous rectal and perineal surgeries, as well as perineal and rectal trauma.

When taking a history, attention should be paid to the time of onset of the first episodes of anal incontinence, the progression of anal sphincter deficiency (ASD) over time, its severity and frequency of episodes; as well as the presence of concomitant diseases, such as rectal prolapse, urinary incontinence, etc. [13].

Of no small importance when taking a history is to pay attention to concomitant factors that may be of indirect significance in the development of ASD symptoms – diabetes mellitus, oncological diseases, history of chemotherapy courses, use of various medications, etc. [14, 15].

Special attention should be paid to the patient's subjective assessment of the severity of anal incontinence symptoms, as well as the impact of ASD on quality of life. For this purpose, various scales and questionnaires have been developed to standardize the collection of anamnestic data, establish the severity of incontinence symptoms, formulate a provisional diagnosis, and determine the most likely etiological causes of the disease development [14] (see Appendix G1-G4. "Scales for Assessing Anal Sphincter Incontinence"):

1. The most common is the Cleveland Clinic Incontinence Score (Wexner scale) [16], in which patients independently assess the degree and frequency of incontinence episodes, the need to use special hygiene products, and the degree of impact of anal incontinence on quality of life.

2. Fecal Incontinence Severity Index (FISI) [17, 18].

3. St. Marks Incontinence Score or Vaizey Score [19, 20].

4. Fecal Incontinence Quality of Life (FIQL) scale [21].

5. Comprehensive Fecal Incontinence Questionnaire (C-FIQ) [22].

2.2 Physical Examination

• All patients with suspected anal sphincter insufficiency are recommended to undergo a physical examination [1, 14]:

1. External inspection of the perineal and anal region.

2. Transrectal digital examination.

GCP CLEL 5Grade of Recommendation – C (Level of Evidence – 5)

Comment: inspection is of critical importance in establishing a provisional diagnosis of anal incontinence. It is performed in the gynecological position, with the patient lying on their back with legs maximally flexed toward the abdomen, or in the knee-chest position, and if impossible, in the lateral position. During the external inspection of the perineal and anal region, the location and closure of the anal opening, the presence of postoperative or post-traumatic scarring in the perianal area, thinning or hypertrophy of the perineal body are determined, and attention is paid to changes in the perianal skin (hyperemia, maceration, rashes, weeping, enlarged external hemorrhoids, fistulous openings, etc.). It is advisable to ask the patient to strain in order to reveal mucosal prolapse or rectal prolapse, as well as other signs of pelvic floor descent syndrome (PFDS) – prolapse and/or descent of the uterus and/or vagina and/or bladder [23].

Next, it is advisable to assess the anal reflex. This maneuver is used to study the contractile capacity of the sphincter muscles. A normal reflex is when stroking the perianal skin results in a full contraction of the external sphincter; an exaggerated reflex is when the perineal muscles contract simultaneously with the sphincter; a weakened reflex is when the reaction of the external sphincter is barely noticeable.

When performing a transrectal digital examination, the presence of scarring of the anal sphincter complex (ASC) is determined: the elasticity and extent of the sphincter muscle fibers and scars are assessed relative to a conventional clock face, along with the integrity and condition of the pelvic floor muscles, and the anatomical relationships of the muscular and bone structures of the pelvic ring. During the examination, the tone and voluntary efforts of the anal sphincter, the nature of its contractions, and the presence of an open (patulous) anus after finger withdrawal are assessed. Attention should be paid to the presence of concomitant diseases of the anal canal and the lower ampullary rectum (rectocele, rectal intussusception, internal hemorrhoids, anal fistula, anal fissure, neoplasms, etc.) [24].

2.3 Laboratory Diagnostics

There are no specific laboratory tests for anal sphincter insufficiency. Laboratory diagnostic tests should be performed in patients during the preparation and planning of surgical intervention to exclude concomitant diseases and conditions.

2.4 Instrumental Diagnostics

• All patients with anal sphincter insufficiency are recommended to undergo an assessment of anal sphincter complex function via sphincterometry (examination of the function of the sphincter apparatus of the rectum) in order to objectify the degree of ASD and predict the results of surgical and/or conservative treatment [12, 26, 27].

GCP ALOE 2Grade of Recommendation — A (Level of Evidence — 2)

Comment: anorectal manometry methods have a sufficiently high sensitivity and specificity in the diagnosis of anal incontinence. According to a 2017 meta-analysis, the overall sensitivity of the study was 0.80 (95% CI: 0.69 – 0.88), and the specificity was 0.80 (95% CI: 0.65 – 0.90) [27].

Sphincterometry makes it possible to evaluate the total contractile activity of the external and internal anal sphincters. The following parameters are assessed: tone and voluntary contraction strength of the anal sphincters. The magnitude of tonic tension characterizes the internal anal sphincter to a greater extent. During voluntary contraction, the contractile activity of the striated muscles of the external sphincter and pelvic floor (PF) is evaluated.

Manometric signs of ASD by grades and their clinical manifestations according to the Wexner anal incontinence scale, taking into account gender differences, are specified in Appendix G5 "Manometric and Scoring Parameters of Various Degrees of ASD".

In addition, clinical practice utilizes the method of comprehensive sphincterometry, which additionally allows for the evaluation of sustained contraction (fatigability, endurance) of the external sphincter and pelvic floor muscles, tests with increased intra-abdominal pressure during coughing and straining of the anterior abdominal wall muscles, as well as the pushing test. Comprehensive sphincterometry allows for a rapid and practically non-invasive assessment of the tone of the sphincter apparatus at rest—which is determined almost 80% by the tone of the internal sphincter and only 20% by the tonic activity of the external sphincter and pelvic floor muscles—and during voluntary contraction, which is mainly driven by the muscle fibers of the external sphincter and pelvic floor (m. puborectalis). The test with increased intra-abdominal pressure (coughing and straining of the anterior abdominal wall muscles) and the straining test (PUSH test) make it possible to study the neuro-reflex activity of the rectal sphincter apparatus to rule out functional defecation disorders (FDD). To increase the sensitivity and specificity of FDD diagnostics, comprehensive sphincterometry can be performed simultaneously with interference electromyography (EMG) (summary electromyography of the external anal sphincter or pelvic floor), which consists in recording the bioelectrical activity (BEA) of the anterior abdominal wall muscles [2, 28 – 31].

EMG is the only method that allows for the assessment of the viability and functional activity of the muscular structures of the anal sphincter complex, which is extremely important in patients with extensive damage to the sphincter apparatus, when it is necessary to assess the presence of preserved external sphincter structures. Furthermore, to identify the pathogenetic links of anal incontinence using EMG, it is possible to diagnose pudendal neuropathy, the presence of which can be of decisive importance in a number of cases.

The EMG study can be limited to interference EMG using surface electromyographic (EMG) electrodes, anal sphincter electrodes, as well as disposable concentric needle EMG electrodes. To study the innervation of pelvic floor muscles, the EMG study may consist of needle EMG to assess motor unit action potentials and/or stimulation EMG to assess the latency of excitation conduction along the motor fibers of the distal part of the pudendal nerve (n. pudendus) [32 – 36].

The method of intra-anal interference electroneuromyography (ENMG) is advisable to use for the objective non-invasive determination of the preservation of bioelectric activity (BEA) in the muscles of the external sphincter and pelvic floor, assessment of their viability based on functional activity, as well as for studying the neuro-reflex reactions of the sphincter apparatus.

Interference ENMG evaluates the tonic and voluntary bioelectrical activity of the external sphincter and pelvic floor muscles at rest and during voluntary contraction, their neuro-reflex reactions during tests with increased intra-abdominal pressure (coughing and abdominal wall straining), as well as the reaction of the puborectalis sling during straining.

Objective dynamic evaluation of ENMG parameters—studies before and after conservative and/or surgical treatment of anal sphincter deficiency (ASD)—is performed in patients with anal incontinence, including to monitor the functional state of the transposed gracilis muscle after graciloplasty, in patients before reconstructive surgeries, and also as a visual test control to assess the state of the anal sphincter complex during biofeedback (BFB) therapy [37 – 40].

• All patients with anal sphincter deficiency are recommended to undergo transrectal ultrasonography (US) of the rectum to determine local structural changes in the muscle structures of the anal sphincter complex, the presence and extent of its defects, and the state of the pelvic floor muscles [41 – 46].

GoR BLoE 2Grade of recommendation - B (level of evidence - 2)

Comment: in patients with a history of childbirth (both uncomplicated and with perineal tears), surgical interventions, or rectal trauma, transrectal rectal ultrasound allows for the visualization of damaged, scarred, or completely absent areas of sphincter muscle fibers that cause ASD, and thus objectively assess the state of the anal sphincter complex [41 – 44]. The use of transrectal 3D rectal ultrasound allows for a more detailed visualization of the elements of the rectal closure apparatus and determination of their topographic and anatomical relationships with surrounding structures. At the same time, the mere presence of a defect in the muscle structures of the anal sphincter complex in itself is not a sufficient basis for establishing a diagnosis of ASD, since the presence of damage to muscle fibers is not always accompanied by the development of symptoms of anal incontinence [47].

2.5 Other Procedures

Additional instrumental and laboratory studies are performed in the presence of comorbid conditions in accordance with relevant clinical guidelines.

3. Treatment, including drug and non-drug therapies, diet therapy, and pain management

3.1 Conservative Treatment

Conservative treatment for ASD is aimed at enhancing the contractile capacity of the anal sphincter and pelvic floor muscles, maintaining and improving the activity of the neuro-reflex apparatus that ensures the normal functional activity of the anal sphincter complex, and includes [48 – 70]:

1. Diet therapy.

2. Drug treatment (antidiarrheal agents).

3. Electrical stimulation using biofeedback (BFB therapy).

4. A set of therapeutic exercises.

5. Electrical stimulation of the anal sphincter and perineal muscles.

6. Tibial neuromodulation.

7. Magnetic field therapy.

8. Use of anal tampons.

9. Use of cleansing enemas and irrigation systems.

It is advisable to use conservative therapy as an independent method of treatment in patients with a functional form of anal sphincter deficiency, as well as in patients with an organic form of ASD in the perioperative period—as a way to improve the effectiveness of surgical interventions in a multidisciplinary approach to treatment, and also as a means of patient rehabilitation when surgical correction of anal incontinence is impossible.

3.1.1 Diet Therapy

• All patients with anal sphincter deficiency are recommended stool regulation using a special diet [50, 51].

Level of Recommendation C (LoR C)Level of Evidence 4 (LoE 4)Level of recommendation confidence - C (level of evidence validity - 4)

Comment: an independent, meticulous self-assessment by the patient of their lifestyle, diet, and habits using diaries can help identify and eliminate factors contributing to the development or progression of ASD symptoms. During a coloproctologist's appointment, it is often not always possible to identify the cause-and-effect relationship between incontinence and various external factors. It is advisable to explain to the patient the need for independent search and careful recording of factors contributing to the occurrence of anal incontinence phenomena. Particular attention should be paid to the laxative effect of caffeine, artificial sweeteners, lactose, and other dietary components that can lead to the development of diarrhea. Studies prove that in 22 – 54% of patients, there is a decrease in the frequency of ASD manifestations after consultation with a specialist and correction of diet, fluid intake, medication intake, and the formation of habits and stable reflexes associated with bowel movements [50 – 55].

Patients with ASD caused by idiopathic stool consistency disorders may be prescribed a diet rich in plant fiber, as well as products containing psyllium and dietary fiber [50, 51]. Nevertheless, the addition of fiber can also lead to worsening of ASD symptoms due to an increase in the volume of intestinal contents [51].

3.1.2 Pharmacotherapy

• All patients with functional anal sphincter deficiency are recommended to undergo conservative treatment (A07DA Propulsives, C02AC Imidazoline receptor agonists) aimed at slowing down the rate of intestinal transit, reducing the production of digestive enzymes, decreasing the secretion of the intestinal mucosa, increasing the absorption of contents, and partially contributing to an increase in sphincter tone [52 – 55].

GCP ALOE 2Grade of Recommendation — A (Level of Evidence — 2)

Comment: liquid stool consistency, as well as an increase in the rate of transit of intestinal contents, are factors contributing to the intensification of anal incontinence phenomena.

3.1.3 Biofeedback-assisted electrical stimulation

• Patients with functional anal sphincter deficiency at the initial stage of treatment, as well as patients with organic ASD before surgical intervention as part of neoadjuvant therapy, are recommended to undergo a course of BFB therapy [56].

GoR BLoE 3Grade of recommendation - B (level of evidence - 3)

Comment: electrical stimulation using biofeedback with pelvic floor muscle training is advisable to use as a method of choice in patients with anal incontinence when drug treatment and dietary correction have proven ineffective (see sections 3.1.1 and 3.1.2).

Electrical stimulation using biofeedback is a training system based on the patient receiving feedback on the functioning of their own body using a "physiological mirror" (a computer monitor with a game interface), various sensors, and training medical personnel. In this case, the exercises that the patient performs independently are monitored by special devices, and the measurement result is demonstrated directly to the patient in real time. Thus, the patient learns to correctly perform the necessary exercises.

In the treatment of anal sphincter deficiency, electrical stimulation using biofeedback is aimed at developing self-regulation of the functional activity of the muscle structures of the anal sphincter complex and the correct perception of sensations capable of improving control over the function of holding intestinal contents.

Existing techniques focus on training the patient to distinguish small volumes of rectal balloon distension and to respond to rectal filling by contracting the external anal sphincter, as well as to reduce the time between the appearance of the sensation of rectal filling and sphincter contraction. Other techniques focus on improving the strength and endurance of the external sphincter.

Modern conservative approaches, often combined with each other, include the following modalities of electrical stimulation using biofeedback:

1) The strength method of electrical stimulation using biofeedback is aimed at increasing the contractile capacity of the muscles of the anal sphincter complex and pelvic floor. Exercises are repeated every 20 – 30 minutes with rest intervals; the course of treatment ranges from 10 to 15 sessions.

2) The coordination method of biofeedback is aimed at developing a conditioned rectoanal inhibitory reflex (RAIR). Exercises are repeated every 20 minutes; the course of therapy is 10 – 15 sessions.

Information on the functional activity of perineal muscle structures, the strength of muscle contractions of the anal sphincter complex and pelvic floor is provided to the patient in an accessible, visual form of an electromyogram pressure graph on the display or as a multimedia option; the state of intra-abdominal pressure is presented as changes in the BEA of the anterior abdominal wall muscles.

The effectiveness of electrical stimulation using biofeedback ranges from 64 to 89% [56].

• Patients with functional anal sphincter deficiency and patients with grade 1–2 organic anal sphincter deficiency (ASD) are recommended to perform pelvic floor muscle strengthening exercises combined with biofeedback-assisted electrical stimulation to enhance the therapeutic effect (see section 3.1.4) [57].

Level of Evidence – AGrade of Recommendation – 2Level of Clinical Usability – A (Level of Evidence – 2)

• Patients with functional anal sphincter deficiency and patients with grade 1–2 organic ASD are recommended to undergo anal sphincter electrical stimulation simultaneously with a course of biofeedback therapy to enhance the therapeutic effect (see section 3.1.5) [58].

Level of Evidence – AGrade of Recommendation – 2Level of Clinical Usability – A (Level of Evidence – 2)

3.1.4 Therapeutic physical training complex

• Patients with functional and organic forms of anal sphincter deficiency are recommended to undergo a course of exercise therapy (therapeutic exercises for colon diseases) [57, 59].

Level of Evidence – AGrade of Recommendation – 2Level of Clinical Usability – A (Level of Evidence – 2)

Comment: the therapeutic exercise complex is performed to increase the strength, contraction speed, and endurance of the pelvic floor muscles. The course of treatment takes from 15 to 30 days and should be carried out, if possible, after biofeedback-assisted electrical stimulation, once the patient has already been trained to correctly contract the muscles of the anal sphincter and pelvic floor [57].

3.1.5 Electrical stimulation of the anal sphincter and perineal muscles

• In patients with functional and grade 1–2 organic anal sphincter deficiency, with linear defects of muscle fibers not exceeding 1/4 of the circumference, in the absence of anal deformation, as well as in the preoperative period, it is recommended to use anal sphincter electrical stimulation as an independent treatment modality [60, 61].

GOM BLOE 3Grade of Recommendation - B (Level of Evidence - 3)

Comment: electrical stimulation of the anal sphincter and perineal muscles is performed using various devices (stationary and portable) with special anal sphincter electrodes at a pulse frequency of 10 to 100 Hz in intermittent and continuous modes. The course of intra-anal electrical stimulation is 14 days. The session duration is 20 minutes; if a repeat stimulation course is necessary, the interval between courses is 3 months. A positive aspect of this treatment method is the possibility of prolonged outpatient use of a portable myostimulator. Using a reusable pressure sensor (anal or vaginal), the patient can perform pelvic floor muscle training on an outpatient basis according to an individually designed treatment program, which allows sequential stimulation of various pelvic floor muscles (external anal sphincter or m. puborectalis) [61].

• Patients with functional anal sphincter deficiency are recommended to undergo modulated medium-frequency electrical stimulation combined with biofeedback-assisted electrical stimulation and pelvic floor muscle training to improve treatment outcomes [58, 60].

Level of Evidence – AGrade of Recommendation – 2Level of Clinical Usability – A (Level of Evidence – 2)

3.1.6 Tibial neuromodulation

• Patients with functional ASD, as well as in the pre- and postoperative period during surgical correction of anal incontinence, are recommended to undergo tibial neuromodulation (electrical stimulation) [62].

Level of Evidence – AGrade of Recommendation – 2Level of Clinical Usability – A (Level of Evidence – 2)

Comment. Posterior tibial neuromodulation is a non-invasive or minimally invasive alternative to direct sacral nerve stimulation. It is believed that tibial nerve neuromodulation leads to neuromuscular changes in the anorectal region similar to those caused by sacral plexus stimulation due to the shared innervation of these regions from the same spinal segment [62, 63].

The method consists in affecting the pelvic-sacral nerve plexus (S2–S4) by electrical stimulation of the posterior tibial nerve in the lower extremities. By stimulating autonomic, sensory, and motor nerves, the technique improves the tone, contractility, and neuro-reflex activity of the anal sphincter muscles. Stimulation is performed using disposable surface EMG electrodes placed in the projection of the posterior tibial nerve. Treatment parameters: current intensity — 20–25 mA; frequency — 20 Hz; mode — intermittent; stimulation period — 5 sec, rest period — 10 sec; session duration — 20 min. The duration of the treatment course with surface electrodes is 1 time per day for 1 month, then 1 time every 3 days for 3 months. Improvement in continence function after tibial neuromodulation is observed in 65–85% of cases [62, 63, 64].

3.1.7 Magnetic field therapy

• Patients with functional anal sphincter deficiency and patients with organic anal incontinence in the perioperative period are recommended to undergo magnetic field therapy [65–67].

GOM BLOE 3Grade of Recommendation - B (Level of Evidence - 3)

Comment: a number of studies indicate that the application of an alternating magnetic field activates large sacral motor nerve fibers that innervate the striated musculature of the external sphincter and pelvic floor muscles. This leads to an increase in the tone and contractility of these muscles.

Magnetic field therapy implies "electrodeless" stimulation. The duration of the magnetic field action is usually 300 ms. Excitation of the pudendal nerve motor fibers has a direct effect on the contractile activity of the sphincter and perineal muscle fibers [66].

3.1.8 Anal plug

• All patients with grade 2–3 anal sphincter deficiency in whom surgical correction of anal incontinence is not feasible are recommended to use an anal plug [68].

LoR AQoE 1Level of Recommendation — A (Level of Evidence — 1)

Comment: the use of an anal plug is based on the mechanical sealing of the anus with a special soft plug inserted into the anal canal. The plug comes in two sizes: large (L) and small (S). The average duration of use for a single plug is about 12 hours. Contraindications for use include severe diarrhea, intestinal infections, and inflammatory bowel disease. In a number of patients, the use of an anal plug causes discomfort, which is an obstacle to its use. In severe anal sphincter deficiency, the use of an anal plug helps reduce the incidence of maceration and inflammatory changes in the perianal skin.

3.1.9 Cleansing enemas and irrigation systems

• All patients with congenital grade 2–3 anal sphincter deficiency, anal incontinence caused by spinal cord injuries, and severe constipation, in whom surgical correction of ASD is not feasible, are recommended to use cleansing enemas and irrigation systems for mechanical bowel cleansing [69–71].

GOM BLOE 3Grade of Recommendation - B (Level of Evidence - 3)

Comment: colon irrigation can be performed either through the anus (retrogradely) or via a cecostomy, transverse stoma, or sigmoid stoma (antegraderatived/antegrade). Colon evacuation is more effective with antegrade use of irrigation systems compared to retrograde use. Retrograde use of cleansing enemas is preferable due to its non-invasive nature. The most common adverse events associated with the antegrade method are stoma stenosis and leakage of irrigation fluid from the stoma. The use of enemas and irrigation systems improves the quality of life of patients with ASD (their occupational and social rehabilitation) in 75–92% of cases [71]. Side effects of retrograde irrigation occur in 61% of patients, 43% of patients report prolonged leakage of irrigation fluid, 17% report abdominal cramps, and 16% report abdominal pain [70].

3.2 Surgical Treatment

Surgical treatment is the primary approach for patients with organic anal incontinence. The goal of surgical interventions is to improve the bowel content retention function, which can be achieved through the following methods [35, 39, 47, 59, 72–103]:

1. Correction of rectal sphincter defect(s) using local tissues and/or skeletal musculature (various types of muscle plastics).

2. Injection of biocompatible fillers into the anal canal (injection method).

3. Controlled scarring induced by thermal action of radiofrequency energy (radiofrequency thermoablation).

4. Sphincteroplasty with artificial sphincter implantation.

5. Sacral neuromodulation.

6. Implantation of a magnetic anal sphincter.

If the above surgical treatment methods are ineffective in patients with ASD, the issue of creating a permanent diverting stoma should be considered [104–106].

3.2.1 Procedures using the patient's own tissues aimed at restoring the muscular structures of the rectal sphincter

• All patients with anal sphincter deficiency caused by local defects of the external sphincter up to ¼ of the circumference in size are recommended to undergo sphincteroplasty [1, 47, 59, 73].

GoR BLoE 2Grade of recommendation - B (level of evidence - 2)

Comment: depending on the method of suturing the ends of the muscle structures, sphincteroplasty can be direct or overlapping. It should be noted that there are no statistically significant differences in the efficacy of direct versus overlapping sphincteroplasty. Depending on the location of the muscle defect, sphincteroplasty can be:

1) anterior;

2) posterior;

3) lateral.

Method: A semilunar incision is made in the perineal skin, after which the ends of the external anal sphincter are isolated from scar tissue and approximated tension-free end-to-end or overlap, thus restoring the circular integrity of the muscles. Good treatment outcomes are possible only with adequate mobilization of both ends of the sphincter, yet excessive mobilization is hazardous due to the risk of nerve fiber injury.

• Patients with postpartum anal sphincter deficiency are recommended to undergo anterior sphincteroplasty [1, 59, 74, 75].

GCR CLOE 3Level of recommendation evidence - C (level of data reliability - 3)

• Patients with anal sphincter deficiency caused by a sphincter defect located in the posterior semicircle, multiple sphincter defects, as well as in cases of ineffective management of anal sphincter deficiency following previously performed anterior sphincteroplasty, and in the presence of severe scar deformity of the anterior semicircle of the anus, are recommended to undergo posterior sphincteroplasty [76].

GCR CLEL 4Grade of Recommendations — C (Level of Evidence — 4)

Comment: anterior and posterior sphincteroplasties may be performed in combination with each other. The complication rate following sphincteroplasty is low, with suture dehiscence being the most dangerous complication. In the early postoperative period, good results are achieved in more than 70% of patients, and excellent results in 50% of cases. When correcting postpartum anal sphincter deficiency, the efficacy of sphincteroplasty reaches 85%. However, long-term treatment outcomes indicate a positive effect in only 10 to 14% of patients 5 years after the intervention [75].

• All patients with grade 2–3 anal sphincter deficiency caused by a sphincter defect ranging from ¼ to ½ of the circumference located in the anterior or posterior semicircle of the sphincter, when other options for incontinence correction are ineffective, are recommended to undergo sphincterolevatoroplasty [77, 78].

GoR CLoE 5Grade of Recommendation - C (Level of Evidence - 5)

Comment: the efficacy of this technique reaches up to 50% in individual studies [78].

• All patients with extensive post-traumatic sphincter muscle defects, congenital developmental anomalies accompanied by the absence of the anal sphincter apparatus, and patients with grade 2–3 anal sphincter deficiency when correction of anal incontinence by other methods is impossible, are recommended to undergo muscle plasty using skeletal musculature [79–82, 84–86].

GoR BLoE 3Grade of recommendation - B (level of evidence - 3)

Comment: the skeletal muscles most frequently used for plastic surgeries aimed at anal sphincter replacement are gracilis muscle plasty and gluteus muscle plasty.

The essence of gracilis plasty (formation of the anal sphincter from the gracilis muscle of the thigh) consists of isolating the muscle on the inner surface of the thigh, forming a subcutaneous tunnel, and suturing the tendon of m. gracilis to the ischial tuberosity on the contralateral side. Rapid muscle fatigue and the inability of patients to voluntarily contract the transposed muscle are the main reasons why patient satisfaction with treatment outcomes after gracilis plasty does not exceed 50%, although according to some data, the efficacy of the procedure can reach 76.5% [81]. When combining gracilis plasty with the placement of an electrical stimulator (dynamic gracilis plasty), the efficacy of the method ranges from 45 to 80% [82]. According to a meta-analysis including treatment outcomes for 450 patients with anal sphincter deficiency from 14 studies, the weighted average rate of continence restoration following dynamic gracilis plasty is 69.1% (95% CI: 0.53–0.84%), and for adynamic gracilis plasty, it is 71% (95% CI: 0.54–0.87) [82]. The most frequent complication that casts doubt on the efficacy and appropriateness of the technique is stimulator explantation in 42% of cases.

In turn, there are the following types of surgeries using the gluteus maximus muscle: gluteoplasty and sphincterogluteoplasty. Each of them can be either unilateral or bilateral. In addition, in certain cases, a dynamic gluteoplasty variant is used.

Gluteoplasty is advisable to use in patients with grade 3 anal sphincter deficiency caused by a sphincter defect of more than ½ of the circumference, in severe traumatic injuries and developmental anomalies of the rectal closure apparatus. It can be performed in one or several stages [85].

Sphincterogluteoplasty is advisable to use in patients with grade 3 anal sphincter deficiency caused by a defect of 50% of the sphincter, localized along its lateral semicircles [86].

The most common complication when performing extensive plastic surgeries using the gluteal muscles is wound suppuration, occurring, on average, in 25% of cases. According to various data, the efficacy of this technique can reach 73% with an overall complication rate of 38% [86].

At the same time, bilateral gluteoplasty is preferable to unilateral gluteoplasty due to a larger muscle mass volume and a more uniform distribution of muscle forces compressing the anus [86].

3.2.2 Injection method

• All patients with grade 1 anal sphincter deficiency, as well as patients with postoperative anal deformations, are recommended to undergo injection of biocompatible fillers into the anal canal [88–90].

LoR AQoE 1Level of Recommendation — A (Level of Evidence — 1)

Comment: the essence of the method lies in improving "passive" continence function. When treating anal sphincter deficiency using the injection method, it is recommended to use silicone fillers [89]. Injection of silicone materials can improve continence function in 23% of patients. Injections can be performed either under ultrasound guidance or without it. The drugs are administered into the submucosal layer of the anal canal in the projection of the sphincter defects or around them into the intersphincteric space or the submucosal layer [88].

Improvement of continence function is observed in 15–52% of patients in the early postoperative period [89], however, over time, only about 6% of patients note the persistence of the effect from the procedure [89–91]. In patients with a rapid fading of the effect, it is advisable to repeat the procedure, which helps improve outcomes [92].

The injection method of treatment is contraindicated in patients with anal sphincter deficiency who have concomitant diseases of the anorectal region (inflammatory bowel disease, rectocele, rectal prolapse, anorectal malformations, post-radiation proctitis) [88, 89].

3.2.3 Radiofrequency thermal ablation

• Patients with grade 1 anal sphincter deficiency are recommended to undergo treatment of the rectal closure apparatus structures with temperature-controlled radiofrequency energy (radiofrequency thermal ablation) [93].

Level of Evidence CQuality of Evidence 3Strength of Recommendation - C (Level of Evidence - 3)

Comment: the purpose of the technique is to increase the tone of the anal sphincter apparatus through controlled scarring caused by the thermal effect of radiofrequency energy (465 kHz) on several areas located within the thickness of the anal canal tissues, without damaging the mucous membrane. This procedure has low efficacy. An improvement in continence function by 50% (according to questionnaires) was recorded in less than 38% of patients, and complete disappearance of anal sphincter deficiency symptoms after the manipulation was not registered in a single observation [93].

Radiofrequency thermal ablation is contraindicated in patients with inflammatory bowel disease, diarrhea, chronic constipation, post-radiation bowel lesions, as well as those who have previously undergone injection treatment methods for anal sphincter deficiency [93].

3.2.4 Sphincteroplasty with artificial bowel sphincter implantation

• Patients with grade 2–3 anal sphincter deficiency accompanied by damage to the anal sphincter of more than ½ of the circumference or congenital absence of the rectal closure apparatus, severe neurogenic injuries, as well as patients in whom other treatment methods for anal incontinence have proven ineffective, are recommended to undergo sphincteroplasty with artificial sphincter implantation [90, 94].

GoR BLoE 2Grade of recommendation - B (level of evidence - 2)

Comment: the artificial sphincter is a circular silicone reservoir that increases in volume by filling with liquid gel. Through separate incisions, the implant is placed around the distal rectum, and a gel bulb is implanted separately into the soft tissues, which is pumped between the artificial sphincter and the bulb using a pump. The technique allows the patient to voluntarily empty the bowels and retain defecation. A disadvantage of the method is the high rate of wound suppuration in the area of the implanted artificial sphincter, resulting in the need to remove the device. The explantation rate ranges from 20 to 80%. After 5 years of follow-up, 59% of patients are satisfied with the device's function [90, 94].

Absolute contraindications for this method are: the presence of purulent collections in the perineal region, inflammatory bowel disease, radiation proctitis, and severe scar deformity of the perineum.

3.2.5 Sacral neuromodulation

• Patients with grade 1–3 anal sphincter deficiency are recommended to undergo sacral neuromodulation (electrical stimulation) [95, 96].

GCR CLOE 3Level of recommendation evidence - C (level of data reliability - 3)

Comment: the technique is effective in 69-83% of patients in the first year after implantation. At the same time, patients report a reduction in incontinence symptoms by more than 50%. Long-term treatment outcomes show even greater positive dynamics, with satisfactory continence function after 3 years in 84% of patients. In addition, 35% of patients report 100% fecal continence [97, 98].

The incidence of purulent-inflammatory complications is about 11%, but within 5 years of follow-up, 24% of patients required implant replacement [98]. Pudendal nerve conduction impairment, as well as previous attempts at surgical treatment of anal incontinence, do not affect the efficacy of sacral neuromodulation [99]. The intensity and stimulation mode are controlled by the patient using an external device [100, 101].

3.2.6 Creation of a diverting intestinal stoma

• Patients with grade 1–3 anal sphincter deficiency in whom all the above methods of correcting anal incontinence have proven ineffective are recommended formation of a permanent diverting stoma (colostomy) [104, 105].

GCR CLEL 4Grade of Recommendations — C (Level of Evidence — 4)

Comment: when various methods of treating anal sphincter deficiency are ineffective and others cannot be applied, the formation of a permanent stoma significantly improves the patient's quality of life and increases their chances of social and occupational rehabilitation [104, 105]. Thus, up to 83% of patients suffering from anal incontinence who underwent colostomy report a significant improvement in quality of life [106].

4. Medical Rehabilitation and Sanatorium-Resort Treatment

4.1 General principles of rehabilitation

Rehabilitation of patients with anal incontinence after surgical interventions follows the general principles of rehabilitation after any surgical interventions and consists in the prevention of purulent-inflammatory complications, bleeding, and failure of sutures in muscle structures.

4.2 Specific rehabilitation

• All patients with anal sphincter deficiency who have undergone surgery are recommended normalization of gastrointestinal tract activity and elimination of constipation in order to prevent dehiscence of sutures in the muscular structures of the anal sphincter mechanism [50 - 55].

GCP CLOE 4Grade of Recommendation — C (Level of Evidence — 4)

All patients with anal sphincter deficiency who have undergone surgery are recommended conservative treatment (see section 3.1) [39, 48 - 70, 107].

GoR CLoE 5Grade of Recommendation - C (Level of Evidence - 5)

• All patients with anal sphincter deficiency who have undergone gracilis muscle transposition are recommended a course of electrical stimulation of the gracilis muscle [39].

GCP CLOE 4Grade of Recommendation — C (Level of Evidence — 4)

Comment: electrical stimulation prevents degeneration of the transposed muscles used in plastic surgeries. In addition, it is a powerful method for activating these muscles, promoting the development of muscle strength and tonic tension. Various methods of combined treatment are used:

– in the preoperative period to prepare the gracilis muscle for the creation of a voluntary external sphincter;

– in the postoperative period for the functional correction of the contractile and neuroreflex activity of the created sphincter [39].

It is rational to use the gracilis muscle to model the external sphincter, followed by its electrical stimulation and biofeedback (BFB) therapy cycles aimed at voluntary control of the formed neosphincter. This conservative therapy prevents atrophy of the transposed muscle, increases its contractile capacity, and enables conscious control of the neosphincter.

The duration of muscle preparation for surgery averages 2 weeks. The principle of BFB therapy is to provide the patient, through continuous monitoring of the physiological parameters of the transposed muscle, with the ability to purposefully restructure the functional connections of the central nervous system, reinforcing them with visual, gaming, and other techniques. Functional rehabilitation after surgery includes three stages:

1) Stage one is aimed at ensuring the viability of the transposed muscle and includes electrical stimulation, which begins on days 14–16 after surgery.

2) Stage two begins three months after surgery. It is aimed at developing the muscle strength and performance of the neosphincter and includes a set of measures ensuring conscious control of the neosphincter. The complex consists of electrical stimulation, therapeutic exercise, and BFB therapy using an anal sphincter electrode under EMG control.

3) Stage three is carried out six months after surgery and is aimed at controlling the neosphincter with the development of a conditioned rectoanal inhibitory reflex and increasing the tone of the neosphincter. This is achieved by BFB therapy using exercises aimed at enhancing the tonic component and simulating the rectal filling function, followed by correction of the neosphincter continence response [39].

5. Prevention and Dispensary Observation

5.1 Prevention

Prevention of anal sphincter deficiency consists in eliminating etiological factors contributing to the occurrence of anal incontinence symptoms and includes:

1) Improving the quality of obstetric care and reducing the incidence of postpartum complications.

When obstetric complications arise, correct and timely treatment (suture of ruptures) and adequate postpartum and postoperative management are indicated.

2) Improving the quality of surgical care for patients with diseases of the anal canal and distal rectum (correct choice of surgical treatment, proper surgical technique).

3) Improving the quality of perioperative patient management.

5.2 Dispensary Follow-up

• All patients with any form of anal sphincter deficiency are recommended follow-up by a coloproctologist for the timely detection of worsening continence function and correction of ongoing therapy [1, 12, 14].

GoR CLoE 5Grade of Recommendation - C (Level of Evidence - 5)

Comment: in case of an unstable response to treatment (including after surgery), a timely consultation with a coloproctologist will help prevent the progression of anal incontinence symptoms and develop a further diagnostic and treatment algorithm for each specific clinical situation.

6. Organization of Medical Care

Medical care is organized and provided in accordance with:

Federal Law No. 323-FZ of November 21, 2011 (as amended on June 13, 2023) "On the Fundamentals of Protecting the Health of Citizens in the Russian Federation"

Decree of the Government of the Russian Federation No. 1968 dated November 17, 2021 (as amended on March 14, 2024) "On Approval of the Rules for the Phased Transition of Medical Organizations to the Provision of Medical Care Based on Clinical Guidelines Developed and Approved in Accordance with Parts 3, 4, 6–9, and 11 of Article 37 of the Federal Law 'On the Fundamentals of Protecting the Health of Citizens in the Russian Federation'"

Order of the Ministry of Health of the Russian Federation No. 206n of April 2, 2010 (as amended on February 21, 2020) "On Approval of the Procedure for Providing Medical Care to the Population with Colorectal, Anal Canal, and Perineal Diseases in Coloproctology"

Order of the Ministry of Health of the Russian Federation No. 404n dated April 27, 2021 (as amended on September 28, 2023) "On Approval of the Procedure for Preventive Medical Examinations and Clinical Examinations (Dispansevizatsiya) of Certain Groups of the Population"

Order of the Ministry of Health of the Russian Federation No. 1363n dated December 23, 2020 "On Approval of the Procedure for Referring Insured Persons to Medical Organizations Whose Founders' Functions and Powers are Exercised by the Government of the Russian Federation or Federal Executive Bodies, for the Provision of Medical Care in Accordance with the Uniform Requirements of the Basic Compulsory Medical Insurance Program"

Order of the Ministry of Health of the Russian Federation No. 203n of May 10, 2017, "On Approval of Criteria for Assessing the Quality of Medical Care"

6.1 Indications for hospital admission

Conservative treatment of anal sphincter deficiency is carried out in specialized coloproctology departments, including day-care settings.

Surgical treatment of anal sphincter deficiency is performed in specialized coloproctology departments in an inpatient setting.

6.2 Indications for patient discharge from a medical organization

Indications for patient discharge from the hospital are:

1. Uncomplicated early postoperative period (absence of dysuria, increased bleeding, dehiscence of muscle sutures, etc.).

2. Absence of purulent-septic postoperative complications.

7. Additional Information

The outcome of treatment for anal sphincter deficiency is largely determined by the completeness and quality of the diagnostic program, which serves as the basis for selecting the optimal treatment method.

Negative factors affecting the outcome of surgical treatment include:

1. Development of infectious complications.

2. Stool disorders (diarrhea or constipation).

3. Patient non-compliance with the restrictive regimen and dietary recommendations.

Criteria for Evaluating the Quality of Medical Care

Criteria for assessing the quality of primary health care in adults with anal sphincter deficiency (ICD-10 code: K62.8)

Criteria for assessing the quality of specialized medical care in adults with anal sphincter deficiency (ICD-10 codes: K62.8)

References

Appendix A1. Working Group Composition

All members of the working group are members of the Association of Coloproctologists of Russia.

There is no conflict of interest.

Appendix A2. Methodology for Developing Clinical Guidelines

Target audience of the clinical guidelines:

1. Colorectal surgeons.

2. Surgeons.

3. Gastroenterologists.

4. General practitioners / physicians.

5. General practitioners.

6. Endoscopists.

7. Nursing staff.

8. Medical students, residents, postgraduate students.

Table 1. Grading scale for the levels of evidence (LE) for diagnostic methods (diagnostic interventions)

Table 2. Grading scale for the levels of evidence for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)

Table 3. Grading scale for the grades of recommendation (GR) for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)

Procedure for updating clinical guidelines.

The mechanism for updating the clinical guidelines provides for their systematic revision—at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or the presence of justified additions/comments to previously approved clinical guidelines, but no more than once every 6 months.

Appendix A3. Reference Materials

Table 1. Manometric and scoring parameters for various grades of anal incontinence in men [30].

Table 2. Manometric and scoring parameters for various grades of anal incontinence in women [30].

Appendix B. Physician Action Algorithms

Appendix C. Patient Information

No.

Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools

Appendix G1. Russian title: Wexner anal incontinence grading scale

Original title (if any): Continence Grading Scale

Source (official developer website, validation publication): Wexner, S. D. Etiology and management of fecal incontinence / S.D. Wexner, J. M. Jorge // Dis. Colon Rectum. – 1993. – № 36 (1). – р. 77-97.

Type (underline):

- rating scale;

- index;

- questionnaire;

- other (specify)_____________________________________________________

Purpose: the questionnaire is used for the patient's subjective assessment of the severity of anal incontinence symptoms, as well as the impact of anal incontinence on quality of life.

Content (template):

Key (interpretation): evaluation of results after summing the scores:

"0" points – complete continence, "20" points – complete anal incontinence.

Notes: advantages – simplicity and practicality, easy to use and interpret.

Disadvantages – the system is based only on the assessment of subjective data, lack of objective parameters; it does not take into account the patient's psychological state.

Appendix G2. Russian title: Fecal Incontinence Severity Index (FISI)

Original title (if available): Fecal Incontinence Severity Index (FISI)

Source (official developer website, validation publication): Rockwood, T. H. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the fecal incontinence severity index / Т.Н. Rockwood, J. M. Church, J.W. Fleshman, et al. // Dis Colon Rectum. – 1999. – № 42. – р. 1525–1532

Type (underline):

- rating scale;

- index;

- questionnaire;

- other (specify):_____________________________________________________

Purpose: the questionnaire is used for the patient's subjective assessment of the severity of anal incontinence symptoms, as well as the impact of anal incontinence on quality of life.

Content (template):

Fecal gas incontinence:

- never (0 points);

- 1 to 3 times a month (4 points);

- once a week (6 points);

- 2 or more times a week (8 points);

- once a day (11 points);

- 2 or more times a day (12 points).

Mucus incontinence:

- never (0 points);

- 1 to 3 times a month (3 points);

- once a week (5 points);

- 2 or more times a week (7 points);

- once a day (10 points);

- 2 or more times a day (12 points).

Liquid stool incontinence:

- never (0 points);

- 1 to 3 times a month (8 points);

- once a week (10 points);

- 2 or more times a week (13 points);

- once a day (17 points);

- 2 or more times a day (19 points).

Solid stool incontinence:

- never (0 points);

- 1 to 3 times a month (8 points);

- once a week (10 points);

- 2 or more times a week (13 points);

- once a day (16 points);

- 2 or more times a day (18 points).

Key (interpretation): The FISI scale consists of 4 questions with 6 response options each. Thus, the higher the score (from 0 to 61), the more severe the fecal incontinence. It has been established that a significant decrease in quality of life is observed at 30 points and above.

Notes: it differs from other scales in that more severe incontinence symptoms correspond to a higher score than symptoms that have a lesser impact on quality of life.

Appendix G3. Russian title: St. Marks Incontinence Score or Vaizey Score

Original title (if available): St. Marks Incontinence Score or Vaizey Score

Source (official developer website, validation publication): Vaizey, C.J. Prospective comparison of fecal incontinence grading systems/ C.J. Vaizey, E. Carapeti, J.A. Cahill, M.A. Kamm // Gut. – 1999. – №44. – р. 77–80.

Type (underline):

- rating scale;

- index;

- questionnaire;

- other (specify):_____________________________________________________

Purpose: used for the patient's subjective assessment of the severity of anal incontinence symptoms, as well as the impact of fecal incontinence on quality of life

Content (template):

Key (interpretation): minimum score = 0 – perfect continence; maximum score = 24 – complete anal incontinence.                                                                             

Notes has minor differences from the Wexner scale, consisting in the presence of additional questions regarding the use of anti-diarrheal medications and the ability to defer defecation, which makes this classification less intuitive and therefore less frequently used.

Appendix G4. Russian title: Fecal Incontinence Quality of Life (FIQL) scale

Original title (if available): Fecal Incontinence Quality of Life (FIQL)

Source (official developer website, validation publication): Rockwood, T.H. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence/ T.H. Rockwood, J.M. Church, J.W. Fleshman, et al. // Dis Colon Rectum – 2000. – №43. – р. 9–16.

Type (underline):

- rating scale;

- index;

- questionnaire;

- other (specify):_____________________________________________________

Purpose: used for the patient's subjective assessment of the severity of anal incontinence symptoms, as well as the impact of fecal incontinence on quality of life.

Content (template):

Key (interpretation):                                                                                                          

Scale 1 Lifestyle, 10 items: Q2a, Q2b, Q2c, Q2d, Q2e, Q2g, Q2h, Q3b, Q3l, Q3m   

Scale 2 Coping/behavior, 9 items: Q2f, Q2i, Q2j, Q2k, Q2m, Q3d, Q3h, Q3j, Q3n      

Scale 3 Depression/self-esteem, 7 items: Q1, Q3d, Q3f, Q3g, Q3i, Q3k, Q4.

Scale 4 Frustration: Q2l, Q3a, Q3e

Explanation: a psychometric method based on the analysis of four independent qualitative scales reflecting the impact of anal incontinence on lifestyle, behavior, self-esteem, and the cumulative effect of these factors on quality of life. The advantage of this assessment method is the validated, disease-specific fecal incontinence quality of life questionnaire filled out by the patient, assessing the direct and subjective impact of incontinence on the patient's condition. At the same time, a huge disadvantage is the complexity of the scale, which significantly complicates score calculation.