Urinary Incontinence

Implantica’s Solution, UriControl®

Implantica’s UriControl® is subject to further development and approval process. UriControl® is designed to be the world’s first remote controlled artificial urinary sphincter. It is foreseen to significantly improve on existing manual pump concepts to treat urinary incontinence with the use of Implantica’s innovative wireless energized technology.
Most importantly, it is expected to address the 10% of all women suffering from urinary leakage where no optimal treatment exists today.¹

UriControl® is expected to significantly improve existing treatment due to its remote control functionality.

The principle of UriControl® is well proven as the hand pumped artificial urinary sphincter device exists on the market today. UriControl® is expected to be both more convenient and hygienic to use as well as offering improved treatment functionality since it is designed to be operated by a remote-control or push button under the skin. UriControl® is a smart active implant with an advanced pressure regulation system which will work directly on the urethra. It is estimated to both reduce complications and improve treatment efficiency.

UriControl® is foreseen to address the much underserved female market.

UriControl® is estimated to be a ground-breaking device to treat urinary incontinence for both men and women. As it is designed to be recharged wirelessly, it is expected to radically improve quality of life for a very large number of people by providing a solution that restores their dignity and freedom.

1. 1Calhoun, Nygaard & Thom, 2007

Field Description

Voiding dysfunction is a disruption in the ability to urinate or in the ability to consciously control the urination process leading either to urinary incontinence or urinary retention.

• Urinary incontinence – an involuntary release of urine
• Urinary retention – the inability to completely empty the bladder when required

Implantica is focusing on treatment for urinary incontinence with its remote controlled device UriControl®.

Urinary incontinence is a common and often embarrassing problem, which can have a very negative impact on a sufferer’s quality of life. It may affect both young and old, although often surfaces later in life and is common in women, affecting 10% of all women. It has many different causes including the physical strain of childbirth, low estrogen levels after menopause and for men, side effects related to prostate surgery. Urinary incontinence can have a profound impact on the sufferer’s self-esteem and sense of dignity.

Additional treatment solutions in this field such as urinary retention, based on our extensive IP coverage, are part of our pipeline.

Existing Treatments

No optimal treatment exists for urinary incontinence. For women, the most common procedure is a sling placed under the neck of the urinary bladder to try to lift the position of the urinary sphincter, which indirectly improves the urinary leakage problem. Mesh is also used to lift both the neck of the bladder and a fallen uterus. These procedures function by improving the position of the neck of the bladder and are the main surgical methods for treating female stress incontinence. The only available figures on the number of surgeries have shown about 500’000 surgeries performed p.a.³. Complications exist, however, with so called migration/erosion, where sling and mesh pass through tissue, and litigations against these methods are constraining the market.

A special sling procedure exists for men, however, the primary treatment solution for men is an artificial urinary sphincter, which uses a cuff to compress the urethra in order to close it. This hand pumped device is controlled by a manually manipulated pump placed in the scrotum (as a third testicle). While the device works well as intended, the hand-pump can be burdensome at times as the tissue may get irritated and become painful to squeeze with repetitive use. This implant is not often used for women due to a lack of space to place the hand-pumped device.

1. 3HBS Consulting, 2007

Detailed Treatment Field Information

Urination, also known as micturition or voiding, is the process of disposing urine from the urinary bladder through the urethra to the outside of the body. Urinary dysfunction refers to disruptions in the ability to urinate or in the ability to deliberately control the micturition process, normally described as urinary incontinence or urinary retention. Having voiding problems will unconditionally have a negative impact on a sufferer’s ability to work, their social life and day-to-day activities. Implantica is developing a product for the treatment of urinary incontinence, using new wireless technology and remote-controlled implants, in order to present patients with a convenient and sustainable improvement of their quality of life.

Urinary incontinence

Overview

Urinary incontinence is the loss of bladder control resulting in a varying degree of uncontrollable urine leakage. Although the condition itself is benign (not a serious health threat), it is usually associated with embarrassment due to its social consequences. Having problems with urinary incontinence is very common, especially among elderly women or men following prostatectomy (removal of the prostate). Problems with incontinence may often be a serious hindrance in day-to-day activities, and constantly being restricted by the risk of visible soiling or the adjacency to a toilet may greatly affect peoples’ quality of life.

Description and definition

The US National Institute of Health defines urinary incontinence as the “involuntary loss of urine sufficient in amount and frequency to be a social or hygienic problem” (Brooks & Jordan, 2001). As the definition suggests, the severity of the condition ranges from very mild occasional dribbling to more severe and unpredictable wetting.

Causes and effects

• Stress urinary incontinence

The most common type of incontinence is called stress urinary incontinence (SUI); a leaking of urine when pressure is put on the bladder. This can happen during sports, when laughing or coughing or doing other physical activities. It is caused by a weakened sphincter muscle (see Figure 1) or weakened pelvic floor muscles. For women, possible causes to SUI include changes in hormone (oestrogen) levels and nerve functions from aging, pregnancy and menopause. For men the most common cause is complications related to prostate surgery.

^Fig.1

• Urge urinary incontinence

The second most common type of incontinence is urge incontinence. Urge incontinence is characterized by a sudden and strong urge to urinate that is hard to suppress. The urge is often intense enough to be followed by an unintended loss of urine. A more familiar expression for the condition is “overactive bladder”. The symptoms of overactive bladder occur in most cases because the muscles of the bladder involuntarily and prematurely contract. With normal bladder function this is supposed to happen voluntarily when voiding, in coordination with relaxation of the pelvic floor muscles and the urinary sphincter muscles. The causes of an individual patient’s involuntary bladder contractions are hard to identify, but common reasons are neurological disorders (such as Parkinson’s disease or due to spinal cord injury), urinary tract infection, abnormalities in the bladder (such as tumours), enlarged prostate, constipation or previous incontinence surgery.

• Other types of incontinence

Other types of incontinence include mixed incontinence (symptoms related to both stress and urge incontinence), functional incontinence and gross total incontinence. Functional incontinence is incontinence that is unrelated to the physical functionality of a patient’s urinary tract. This type of incontinence is usually diagnosed by excluding all other causes, and can for example be a result of a patient’s lack of ability to go to the bathroom on their own.

Existing treatments

• First line treatments

Below are the treatments available for urinary incontinence that are used in less severe cases of urinary incontinence, and thus not a direct alternative to Implantica’s intended product offerings.

Behavioural methods and exercise techniques. Urinary incontinence can be caused by weakened pelvic floor muscles, and therefore bladder function can be improved by performing exercises to strengthen these muscles and the urinary sphincter. In addition, a strict voiding schedule has the possibility to reduce unplanned incidents. For patients with lesser complications, these exercises and behavioural methods are usually the first types of treatment recommended by physicians. The rate of symptomatic improvement among (female) patients performing so-called Kegel exercises has been shown to be approximately 61% (Barry, 2003).

Pads. Incontinence pads do not actually affect the urine flow, but can provide added confidence for patients through absorbing leakage and protecting clothing. Using such incontinence aids for patients with cognitive difficulties can prove especially helpful.

Drug treatments. Drugs used for treating urinary incontinence generally focus on either relaxing or contracting the bladder muscles depending on the type of incontinence being treated. However, a large portion of the drugs in use are not selective for the bladder (i.e. affecting larger parts of the nervous system than just those specific to bladder function), resulting in unwanted side-effects. This may be especially restrictive for certain patient groups, such as the elderly or patients with cardiovascular disease. Moreover, drug treatment of incontinence has a fairly limited efficacy, and is generally only useful for patients with relatively mild symptoms.

Hormone replacement therapy. Oestrogen deficiency following menopause is thought to be a significant factor in the onset of stress and urge incontinence in post-menopausal women. The reason for this is that oestrogen is believed to play a major role in maintaining urogenital muscle tone, and a large portion of post-menopausal women experience some degree of urogenital atrophy. Treatment with oestrogen replacements (such as Östriol/Ovesterin) may increase the lost muscle tone as well as improve urethral closure and detrusor stability (Barry, 2003).

Catheters. A catheter is a tube that can be inserted into a body cavity, duct or vessel. When treating urinary incontinence with catheterization, the catheter is usually inserted via the urethra into the bladder. The catheter can either be internal where the urine is stored within the bladder and drainage is controlled using a valve, or external, where the urine drains into a storage bag strapped to the body. As with other intraurethral devices, urinary catheters impose a very high risk of infection and need to be managed with extreme care.

• Second line treatments

Covered below are the most commonly used surgical and implanted treatment methods for severe stress incontinence and intrinsic sphincter deficiency. These methods are related to Implantica’s incontinence-related targeted product offerings.

Artificial urinary sphincter (AUS). Existing artificial urinary sphincters consist of a silicone cuff or similar device that squeezes the urethra closed, mimicking a biological sphincter muscle (see Figure 2). A manually manipulated pump is placed in the scrotum or in the area of labia majora. Artificial sphincters can be used for both men and women and have shown success rates of up to 94% (Barry, 2003). The most common indication for AUS placement is male stress urinary incontinence due to radical prostatectomy (RP), so-called post-prostatectomy incontinence. The implant is quite rarely used for women due to the more complicated surgical procedure needed as well as the discomfort for female patients of manipulating a pump placed in the labia. There is today only one commercially available AUS, American Medical Systems’ AMS 800.

^{Fig. 2}

Sling procedures. With this type of procedure, a sling is placed under the bladder neck to prevent it from descending during physical activity. The sling is usually synthetic, but rectus fascia (the patient’s own tissue) or cadaver allografts (tissue from a donor) can also be used. The surgery can be performed either through an abdominal incision or with a transvaginal sling introduced through the vagina. There are slings for both male and female use, and slings are the most common surgical method for treating severe cases of female stress incontinence. Success rates are in the region of 85%, but may be less in a longer-term perspective (Barry, 2003).

Transvaginal tape. Tension-free transvaginal tape (TVT) works in a similar way to a sling, but instead of supporting the bladder neck, the tape is placed around the mid-section of the urethra. TVT has fairly high success rates, but can due to its mid-urethral placement cause erosion, which is a serious side-effect. TVT is used for treating female incontinence. Success rates in the region of 60-70% have been reported (Barry, 2003).

Bulking material implants. Bulking agents such as collagen, silicone or carbon can be injected into the tissues surrounding the bladder neck for improved support and to aid the closure of the urethra in cases of stress incontinence caused by sphincter deficiency. Symptomatic relief is achieved in around 30-50% of women undergoing bulking implant procedures, but is relatively short-term and usually require multiple injections (Barry, 2003).

Retropubic suspension. Retropubic suspension is a surgical method (not an implant) used to correct the position of the bladder and the urethra in cases of stress incontinence caused by urethral hypermobility (movement of the urethra outside the pelvic cavity, caused by weakened pelvic floor muscles). The bladder neck and the urethra are surgically secured to structures within the pelvic cavity in order to prevent further movement and involuntary opening of the bladder neck at times of physical activity.

Electrical stimulation. Electrical stimulation of nerves and muscles has proven to be successful for treating certain cases of stress incontinence and urge incontinence. In these cases, usually either the pelvic floor muscles or the sacral and posterior nerves have been subjected to electrical stimulation. The most commonly used product for nerve stimulation for incontinence treatments is the Medtronic InterStim® Therapy.

Socio-economic burden

Problems with voiding dysfunction are a large economic burden on society. For example, the cost of urinary incontinence in the US is estimated to be approximately USD 16.3 billion every year, counting costs of routine care, nursing home admissions, treatments, associated complications as well as diagnosis and evaluations (Wilson et al., 2001).

The largest portion of the direct economic burden of voiding dysfunctions comes from routine care. In the case of incontinent American women, routine care stood for 70% of the total incontinence costs, while the total cost of all treatment (surgical as well as pharmaceutical) was less than 10% of the incontinence-related expenditures (Wilson et al., 2001). This indicates that safe, sustainable and life-long treatments such as the implant being developed by Implantica could radically reduce the costs of routine care and lead to a more cost-efficient treatment of voiding disorders.

Another aspect is the improvement in quality of life that patients are expected to experience due to an Implantica implant. Although intangibles (such as quality of life) are hard to quantify in economic terms, long-term effects of a healthier and more vital patient population will certainly be positive.

Field conclusion

Having problems with the urinary cycle may be a serious hindrance in day-to-day activities, leave the patient with a considerably decreased sense of freedom as well as, in some cases, become a serious health threat if left untreated. Implantica is developing a novel solution to patients with severe voiding dysfunction, whether it is post-prostatectomy incontinence or female incontinence. Implantica’s device is targeting to offer a previously unavailable restoration of a patient’s quality of life due to remote controlled devices energised wirelessly, and ground-breaking stimulation technology combined with hydraulic constriction.