Fecal Incontinence

Implantica’s Solution, RectalRestore®

Implantica’s RectalRestore® is subject to further development and approval process. RectalRestore® is designed to be our innovative solution to the debilitating impairment of anal incontinence. Our wirelessly controlled and rechargeable implant is designed to manage defecation for patients suffering from fecal incontinence, an often embarrassing and isolating condition. As an active sphincter implant, RectalRestore® will be based on similar functionality and technology as UriControl®, our solution to urinary incontinence.

RectalRestore® has the potential to allow patients complete control over their bowel emptying by a combination of applied hydraulic pressure and electrical stimulation onto the intestine. The solution is expected to enable opening and closing of the bowel in a manner that mimics the bowel organs’ natural functions.

RectalRestore® is expected to enable opening and closing of the bowel in a manner that mimics the bowel organs’ natural functions.

RectalRestore® is designed to have a wirelessly adjustable hydraulic cuff that is intended to apply a minimum of force against the anal canal, and electrical stimulation should then close the remaining opening completely. By regularly changing the position of the electrical stimulation, steady blood circulation in the intestinal wall is estimated to be achieved, preventing erosion or any other damage to the bowel, which will be a significant improvement over existing treatment procedures. The implant is planned to be placed in the body through laparoscopy which should minimize infection risk significantly as compared to existing solutions.

Benefits of RectalRestore®

Remote-controlled, wirelessly recharged

The easily adjustable remote control or push button under the skin is designed to enable patients with fecal incontinence to control bowel movements, thereby radically improving patients’ quality of life and social confidence.

Adaptable intelligent pressure to prevent damage to the bowel

RectalRestore® is anticipated to be safer than existing products as the position at which pressure is applied onto the intestine is expected to be changed over time. The closing mechanism is expected to be controlled not only by hydraulic pressure but also by electrically evoked physiological contractions, constantly changing position.

Safer, less risk of infection

Existing treatment solutions are plagued with very high incidence of infection. Risk of infection should be drastically reduced since RectalRestore® is placed laparoscopically via the abdomen rather than with open surgery from the anus region.

Field Description

Fecal incontinence (FI) is the inability to control bowel movements causing the unintentional passage of feces or stool from the rectum. The symptoms can range from an occasional leakage of stool while passing gas to a complete loss of bowel control. The International Foundation for Functional Gastrointestinal Disorders (IFFGD) defines fecal incontinence as “the involuntary loss of solid or liquid stool sufficient enough to result in impaired quality of life for the individual”.

FI is surprisingly common and affects men and women of all ages but is most frequent among older people. It is approximately twice as prevalent among women as men, as the condition may result from childbirth or obstetric trauma when injury to the anal sphincter muscle can occur. It affects more than 2 – 10% of the world population¹ or 195 million people, based on an assumption of 3% of the total world population. Underlying causes include inflammatory bowel disease, intra-abdominal infection, injury to the anal sphincter or colorectal cancer, which is one of the most common types of cancer.

FI is a major burden to both patients and society. It can be socially devastating and has a significant impact on the patients’ freedom of action and movement. Patients often feel ashamed and embarrassed and fear of public humiliation may lead to social isolation. The affected person often tries to hide the problem and can be reluctant to disclose FI even to their own physician, making it difficult to obtain an accurate estimate of the true prevalence.² The estimated global prevalence ranges from 2% – 10% of the general population, and in elderly people in residential care, prevalence of FI can be as high as 60%.³ However, this disease is common also in people of younger age, for example childbirth is a common cause for incontinence among younger women.

1. 1ICS 2005
2. 2IFFGD 2016
3. 3Andramanakos 2006

Existing Treatments

No optimal treatment method for fecal incontinence exists on the market today with current treatments often not successful and complications with infections after surgery common. The need for surgery with up to 195 million sufferers is large, however, no acceptable treatment exists and therefore only a small number of surgeries are performed.

Sphincter repair is the standard procedure which is performed on patients with a dysfunctional rectal sphincter due to injury, most commonly during childbirth, or ageing. The procedure consists of re-attachment of the rectal muscles to tighten the sphincter and increase the strength of the anus. Treatment success with this procedure deteriorates over time, with only approximately half of the patients remaining continent after 3 years.⁴

Dynamic graciloplasty is a procedure for those with severe FI and involves a muscle transposition of the gracilis muscle, from the inner thigh, around the anal sphincter to restore bowel control. The procedure can initially be successful, but function deteriorates quickly due to muscle wastage and inability to maintain prolonged muscle contraction.

Sacral nerve stimulation involves application of electrical energy in the abdomen by using an implanted electronic pulse generator to achieve continuous muscle stimulation. The pulse generator is deactivated when the patient wishes to effect defecation. This method never achieved any success as other functional nerves need to be cut.

An artificial bowel sphincter is implanted for end-stage FI patients after other treatments have failed. This surgery is associated with high morbidity and common adverse effects include infections and device erosion⁵ with almost 50% of patients requiring revision surgery.⁶

When success is not achieved from other treatment methods, the end alternative is ostomy surgery. An ostomy is a procedure creating an opening in the body for the discharge of waste, which can be temporary or permanent.

1. 4Ogilvie & Madoff 2007
2. 5HBS Consulting 2007
3. 6Chatoor, Taylor, Cohen & Emmanuel 2007

Detailed Treatment Field Information

Fecal incontinence (FI) – the loss of bowel control – affects about 120 million men and women around the world. For large numbers of patients with severe FI, the end treatment is ostomy surgery.

The intestines extend from the stomach to the anus and consist of the small intestine (duodenum, jejunum and ileum) and the large intestine (colon and rectum). When something is wrong within this complex system, fecal incontinence (FI) may occur. FI is rarely due to one single factor and is, in fact, rather a symptom of underlying disease than a condition of its own.

FI is surprisingly common and affects men and women of all ages. Underlying causes may be inflammatory bowel disease, intra abdominal infection, colorectal cancer, and injury to the colon, rectum or anus. When treating mild FI, a simple adjustment of diet and/or medication is sometimes sufficient. Bowel and anal sphincter retraining is also used. For patients with severe FI, unresponsive to less invasive approaches, the end alternative is ostomy surgery – a procedure performed on millions of people worldwide.

Current treatments are not successful in the long-term and infections and other complications are common. There is a need for development of new methods that can enable patients the freedom of movement and help them restore their dignity and self-esteem. Implantica’s new technological solutions are anticipated to provide increased bowel control with fewer complications compared to conventional treatments.

Description and definition

Fecal incontinence (also referred to as bowel incontinence or stool incontinence) involves the inability to control bowel movements. The symptoms can range from an occasional leakage of stool while passing gas, to a complete loss of bowel control. The International Foundation for Functional Gastrointestinal Disorders (IFFGD) defines fecal incontinence as “the involuntary loss of solid or liquid stool sufficient enough to result in impaired quality of life for the individual”.

The condition can be a socially devastating and has a significant impact on the patients’ freedom of action and freedom of movement. Many patients feel ashamed and embarrassed, and fear of public humiliation may lead to social isolation. The affected person often tries to hide the problem as long as possible, withdrawing from friends and family (NDDIK, 2007). Common everyday activities need careful planning, and some become nearly impossible to perform.

FI can occur at any age, but is most common among older people (who sometimes have to cope with urinary incontinence as well). As the condition may result from childbirth or obstetric trauma, more women than men are affected.

Many patients are reluctant to disclose incontinence, even when talking to their own physician. This reluctance can make it difficult to obtain accurate estimates of the true prevalence of FI. The estimated global prevalence ranges from 2% to 10%. One adult in every hundred has a regular problem (ICS, 2005). However, in the group of elderly people in residential care, prevalence of FI can be as high as 60% (Andramanakos, 2006).

Consequently, the International Continence Society and other spokespersons within this field, call attention to the need for greater public awareness and for more professional interest and research into “the neglected area of fecal incontinence” (ICS, 2005).

^{Fig.2 (left) and Fig. 3 (right)}

Causes and effects

Normal continence depends on the orderly progression of waste material through the large intestine (colon), rectum, and anus. Muscles and nerves interact to propel waste contents, sense its presence, and permit voluntary storage and elimination. Furthermore, bowel function is controlled by four factors: rectal sensation, rectal storage capacity, anal sphincter pressure, and bowel habits (see Figure 3).

FI may be caused by of a variety of conditions, such as constipation, damage to the anal sphincter muscles, damage to the nerves, or pelvic floor dysfunction. People who have long-standing diabetes or multiple sclerosis – conditions that can damage the nerves that help control defecation – may be at risk. Moreover, FI often occurs as a symptom of late-stage Alzheimer’s disease, in which both dementia and nerve damage play a role (NIDDK, 2007).

Common causes of fecal incontinence include:

• Constipation is the most frequent cause of FI. Large, hard stools become lodged and left in the rectum and watery stool can leak out. Furthermore, diarrhoea or loose stool can cause or worsen FI.
• Muscle damage of the internal and external sphincters that can occur during childbirth or haemorrhoid surgery.
• Damage to the nerves that control the anal sphincters, caused by neurologic conditions such as congenital anomalies, multiple sclerosis, stroke, diabetes, injuries to the brain or spinal cord, and dementia.
• Loss of storage capacity by rectal surgery, radiation treatment, and inflammatory bowel disease can cause scarring that makes the walls of the rectum stiff and less elastic. The rectum cannot stretch as much to hold stool and, thereby, cause FI.
• Irritable bowel syndrome (IBS) may cause the bowel muscle to squeeze strongly so that it may be difficult to hold feces in. People with IBS often have to rush to the toilet and some leakage is common.
• Pelvic floor dysfunction, such as abnormalities of the pelvic floor muscles and nerves, is often caused by childbirth and subsequent FI may develop in the mid forties or later. Examples of such abnormalities are impaired ability to sense stool in the rectum, decreased ability to contract muscles in the anal canal, dropping down of the rectum (prolapse), protrusion of the rectum through the vagina (rectocele), and general weakness and sagging of the pelvic floor.
• Inflammatory Bowel Diseases (IBD), such as Crohn’s disease and ulcerative colitis. Crohn’s disease is a chronic disorder that causes inflammation of the digestive or gastrointestinal tract, and commonly affects the small intestine and/or colon. Ulcerative colitis is a chronic disease of the colon, or large intestine. Tiny open sores, or ulcers, bleed and produce pus and mucus and the inflammation makes the colon empty frequently (Crohn’s and Colitis Foundation of America, 2008).
• Cancer in the anus and rectum can lead to FI if the cancer invades the muscle walls or disrupt the nerve impulses needed for defecation (Mayo Clinic, 2007). Colon cancer forms in the tissues of the colon, and begins in cells that make and release mucus and other fluids, while rectal cancer forms in the tissues of the rectum (National Cancer Institute, 2008).

Existing treatments

Many people suffering from fecal incontinence (FI) are too embarrassed to seek professional help, or they assume that nothing can be done. This is a pity, as there are ways to treat and manage the condition. However, current methods are seldom successful in the long-term and problems with infection, skin breakdown and other complications are common.

The first step, in the treatment of FI, is an individual assessment to determine the cause. This includes questions as to the history and pattern of the problem, related medical conditions and medications, diet and fluid intake. It is also important to ensure that there are no sinister symptoms, such as bleeding, anaemia or unexplained weight loss, which might suggest bowel disease or even colon cancer (the second most common cancer in Western countries). Sometimes further tests are necessary, to image the anal sphincter muscles (by ultrasound or MRI), to inspect the lining of the bowel (endoscopy) or to test the nerve and muscle function of the lower bowel (anorectal testing). (International Continence Society, ICS, 2005)

Initially, most FI patients receive conservative therapy, including medical treatment and physiotherapy (i.e. electric stimulation and/or pelvic floor muscle training), which is successful for most patients with mild incontinence. These treatments can improve or restore bowel control, or reduce the severity of fecal incontinence. However, the type of treatment depends on the cause and severity of the condition and more than one type of treatment may be necessary. Patients with severe symptoms should preferably be evaluated with endoscopy, and may eventually require surgery (Terra et al., 2005). Unfortunately, none of the current surgical methods can provide satisfactory long-term results for the patient.

In the medical community, success of treatment is usually measured by the reduced frequency of episodes of incontinence. However, for the individual patient, the uncertainty of when an episode of incontinence may occur is the most important factor. It is that uncertainty that influences – and in some individuals may overwhelm – their daily life and sense of personal control (International Foundation for Functional Gastrointestinal Disorders, IFFGD, 2009).

Non surgical treatment methods

The initial treatment paths for patients with mild FI are dietary changes, medication and bowel training – all of which can have a positive impact. The types of food eaten affect the consistency of stool and how quickly it passes through the digestive system. Medication and the use of bulk laxatives can be useful in developing a more regular bowel pattern, but also involve a risk for patients developing a drug addiction or unwanted side effects from the medication.

“It is common that the affected tries to hide the problem as long as possible, withdrawing from friends and family and often do not want to leave the house fearing possible public humiliation.”

Relearning how to control bowel movements and strengthening muscles can be successful for patients with mild FI, or with symptoms caused by constipation. However, it may take some time to develop a regular pattern. Biofeedback is a safe and minimally invasive method using visual feedback to train the pelvic floor musculature. It involves contraction and relaxation of the pelvic diaphragm using sensors (kegels) placed in the vagina or rectum. It is effective for neurogenic and idiopathic FI and for incontinence related to disruption of anal sphincters. Biofeedback has resulted in an improvement in 60% of patients with a 90% reduction in episodes of fecal incontinence (Jorge & Wexner, 1993)

Treatment with bulking agents involves injection of material such as silicone to the sphincter, to add volume to the anal canal and thereby allow better control. This treatment is in the development stage, showing mixed results (HBS Consulting, 2007), and is undergoing clinical evaluation in the US (Person & Wexner, 2005).

Inflatable devices may be used to train anal and rectal distension. The patient is educated to contract the pelvic floor and the external sphincter in response to smaller volumes of distension. Electromyography (EMG) is used to test electrical activity of the muscles. The patient contracts the pelvic floor and anal sphincter to map muscle fibres. Unfortunately, these studies can be uncomfortable and may result in incomplete studies if the patient refuses to continue (Seymour, SD, 2006).

Surgical treatment methods

Patients suffering from fecal incontinence (FI), not responsive to conservative treatment, and patients with an injury to the pelvic floor, anal canal, or anal sphincter, may receive surgical treatment. Several surgical procedures are available; the choice of method is based on the patient history, physical examination findings and results of diagnostic evaluation.

There are a number of treatment methods that have been on the market for several years, but are still considered to be in an experimental stage of development. These include gracilis (thigh) muscle transposition, artificial sphincter implant, the use of bulking agents, and rectal augmentation. All these procedures are currently only undertaken in specialist centres on a small number of patients. (HBS Consulting, 2007)

Surgical treatments for FI are not necessarily easy or free from complications and if these treatment methods fail, the end alternative may be to perform an ostomy, e.g. a colostomy – a surgical procedure where a portion of the large intestine is brought through the abdominal wall to carry stool out of the body.

• Sphincter repair

Sphincter repair (sphincteroplasty) is the standard procedure for FI due to anal sphincter disruption. Sphincter repair is performed on patients who have a dysfunctional rectal sphincter because of injury or aging. Around 30% of all vaginal deliveries result in anal sphincter tears, and a third of these results in symptomatic FI. The procedure consists of re-attachment of the rectal muscles to tighten the sphincter and increase the strength of the anus.

Overlapping sphincter repair is the primary method of management for patients with external sphincter defects, and can produce reasonable results. However, there is a high risk of wound disruption leading to delayed wound healing and infection risks. Recent data shows that treatment success deteriorates over time, and after a three year follow up only 40-62% of the patients remain continent (Ogilvie & Madoff, 2007).

• Post-anal repair

Post-anal repair is a treatment method for patients with anal incontinence where the causes are neurogenic (originating in the nervous system) or idiopathic (of unknown origin). The surgery restores the anorectal angle, lengthens the anal canal and muscles are folded posterior to the rectum. The internal anal sphincter, external anal sphincter, or both, can also be folded during the procedure. Results of post-anal repair decline over time due to the deterioration of the nerves. As newer methods become available, the practice of post-anal repair is decreasing (Abbas & Bisset, 2007).

Surgical procedures designed to preserve the anal sphincter are now common for both cancer and non-cancerous rectal diseases. The invention of circular stapling instruments, allows reconnecting the bowel to the anal sphincters, where it would be almost impossible to do so manually.

• Dynamic graciloplasty (DGP)

Dynamic graciloplasty (DGP) is a muscle transposition of the gracilis muscle around the anus to restore bowel control. DGP is indicated for patients with severe FI, or where less invasive methods have failed, leaving no other treatment option than a colostomy – that is for patients with a destroyed anal sphincter or a sphincter that is denervated or not at all existent.

The procedure involves using parts of the gracilis muscle, from the inner thigh, to encircle the anal sphincter, thereby providing sphincter muscle tone. This type of procedure can be initially successful but, unfortunately, function deteriorates quickly due to muscle wastage and inability to maintain prolonged tonic contraction. Modifications have been tested with low-frequency electrical stimulation to the muscle, for example using an electronic pulse generator (IPG) implanted beneath the skin of the abdomen. However, the results have been disappointing, and the operation involves complications such as evacuation problems, infections and pain. Only approx. 33% of these procedures have a satisfactory continence outcome at three years of follow-up, although half of them will have ongoing evacuation difficulties (Tillin, Chambers, & Feldman, R, 2005).

• Sacral nerve stimulation (SNS)

Sacral nerve stimulation (SNS) involves application of electrical energy in the abdomen, by using an implanted electronic pulse generator (IPG), thereby achieving continuous muscle stimulation. The patient deactivates the IPG whenever they wish to effect defecation. There is only one randomized trial with a reasonable sample size to evaluate the efficacy of SNS after implantation. In this trial, 63% of the patients felt improved during the placebo period, which indicates that there may be no real benefit from the device. The real success rate of SNS is therefore likely to be considerably lower (Matzel, 2007).

• Artificial bowel sphincter (ABS)

Implanting of an artificial bowel sphincter (ABS), also called anal sphincter, is a solution reserved for end-stage FI patients, after other methods have failed. The procedure is an alternative approach to treat a defective dynamic anal sphincter. The ABS is placed around the native sphincter via perianal tunnels and consists of three components: an inflatable cuff (which is the sphincter and occludes the anal canal), a pressure-regulating balloon, and a control pump placed in the scrotum or labia. When the cuff is inflated with fluid, continence is achieved. The control pump regulates the movement of fluid from the balloon to the cuff, and is manually operated by the patient.

ABS surgery is costly and associated with a high morbidity. The most common adverse events are infections (31%) and device erosion (21%) (HBS Consulting, 2007). In about 87% of ABS operations, there are device related complications and almost 50% require revision surgery (Chatoor, Taylor, Cohen & Emmanuel, 2007).

• Ostomy

Where success is not achieved from other treatment methods, the end alternative is ostomy surgery. An ostomy is a procedure creating an opening in the body for the discharge of body wastes. The ostomy may be temporary or permanent.

Socio-economic burden

The socio economic burden of faecal incontinence (FI) and ostomy surgery is substantial. A major problem for patients suffering from FI is the high risk of infection, which prolongs the hospital stay and need for after care. If treated, these patients can enhance their quality of life and become able to return to work. Resources can be released and used within other areas of society, and the cost for medical care can be reduced.

Examples of cost areas are:

• Tied up resources in the health sector and in society as a whole.
• Decreased, or non-existent, productivity affecting the overall economy.
• Financial burden on family, friends and society welfare.

FI has a dramatic impact on the health care system, as existing treatments are often complicated and associated with high costs. The cost of today’s commercially available artificial sphincters ranges from USD 6 400 to 16 000. This can be can be compared to the long-term cost of treatment of FI secondary to childbirth injury, estimated at more than USD 17 000 per patient (Person & Wexner, 2005).

Items with the strongest impact on the overall cost of FI are: incontinence material (diapers, pants, nappies, anal tampons, waterproof sheets, faeces bags etc.), which accounts for a large part of total expenditures. For instance in the US, FI accounts for more than USD 400 million per year for adult diapers only (Kalantar, Howell & Talley, 2002). In addition, it is the second leading cause of admission to long-term facilities in the US (Person & Wexner, 2005).

Furthermore, a large proportion of direct as well as indirect health care costs involved with FI, derive from the cleaning of incontinent patients. It has been estimated that personnel in charge of caring for incontinent patients who are permanently in institutions, devote more than 13% of time available to this duty. However, the cost of health care personnel is not limited only to time and salary. Staff members who spend much of their time cleaning incontinent patients are more prone to dissatisfaction, depression and infection than are those engaged in other activities, and they are more likely to give up their jobs. (Ratto, Ponzi, Di Stasi & Parello, 2007)

Implantica is developing products with the aim to offer more effective treatments, facilitating for surgeons and patients and thereby reducing costs for hospitalization, medication and after care.

Field conclusion

Fecal incontinence is a problematic and often underestimated condition that affects a very large group of people. Besides associated health problems, it is socially devastating and embarrassing to live with lacking control of the bowel and its function, which leads to involuntary excretion and leaking. The existing treatment methods for faecal incontinence (FI) vary in success rate. Current treatments are not successful in the long-term and complications with infections are common. Developments of new methods that can give patients an improved quality of life are needed. Implantica is developing implantable products, which are designed to be placed in the anal canal or rectum and enable patients with fecal incontinence to control bowel movements. This is expected to radically improve the patient’s quality of life.