Implants: An Alternate Treatment Option in Incontinence Care

Incontinence is the involuntary loss of urine or stool, this is a widespread condition and varies with severity from small leaks to complete loss of control of the bladder or bowel. The two main types of incontinence are urinary incontinence and fecal incontinence. According to IQ4I analysis, Incontinence and Ostomy Care global market is estimated to be $15,489.5 million in 2016 growing at mid-single digit CAGR. The incontinence implants global market is expected to grow at a strong double-digit CAGR. The traditional treatment options such as pharmaceuticals and exercise have very little effect on patients with very severe condition. Pharmaceuticals also cause side effects and are not target specific in nature. However, electroceuticals or neuromodulation or neurostimulation devices are highly target specific and affect the patient body electrically rather affecting the chemistry of body leading to tangible immediate effects. These devices have been successful in alleviating conditions in patients where traditional therapies have had little or no success. With better manufacturing procedures, miniaturization and constant innovation, electroceutical has emerged as a new therapy for treating incontinence. The implants used for treating incontinence are nerve stimulators (sacral nerve stimulator and tibial nerve stimulator), slings and sphincters. Among these implants the nerve stimulators gain much of importance as they are permanent treatment option and eliminate the disadvantages caused by other treatment options already available for treating incontinence.

The sacral nerve and tibial nerve are targeted for treating incontinence. The nerve stimulation devices, are implanted under the skin of patient’s and a wire is connected it to the nerve that runs from the spinal cord to the bladder and emits an electrical impulse that stimulates the nerve which thereby helps in bladder control. Percutaneous tibial nerve stimulation uses electrical stimulation of the tibial nerve, which is located in the ankle, to treat urinary incontinence. Sacral nerve stimulation involves a health care professional implanting a battery-operated stimulator beneath the skin in the lower back near the sacral nerve. Some of the examples of electroceutical devices used are Interstim developed by Medtronic for the treatment of urinary urge incontinence and the only device been approved for bowel control or fecal incontinence.

Apart from nerve stimulation devices for treating incontinence, the other implants used in treating incontinence are slings and sphincters which are used in treating both urinary as well as fecal incontinence. Artificial sphincters are used when a sphincter muscle that is circular in shape and maintains constriction of a body passage or orifice and relaxes when required is damaged due to various diseases. In January 2016, Torax Medical Inc. launched an innovative, FDA approved, magnetic sphincter for fecal incontinence called Fenix. It is a small flexible band of interlinked titanium beads with a magnetic core. Slings are meshes used to create a pelvic hammock around the bladder neck and urethra to keep them closed during normal activities.

Growing prevalence of medical conditions such as women related conditions (for e.g. childbirth, menopause), inflammatory bowel diseases (Crohn’s disease and ulcerative colitis), neurological diseases (multiple sclerosis, Parkinson’s disease etc), oncology (colorectal and prostate cancer) and others diseases, increase in population prone to aging related medical conditions, increase in awareness and acceptance of the condition of incontinence, and development of more personalized products for greater patient comfort and care, permanent treatment option, the main advantage of neurostimulator is withdrawal of treatment immediately when a patient shows adverse reaction are driving the market growth.

Recently in 2016, Axonics Modulation Technologies received CE approval for Sacral Nerve Modulation (SNM) system to treat overactive bladder, urinary retention and faecal incontinence through sacral nerve stimulation. Likewise, Medtronic launched NURO System that delivers percutaneous tibial neuromodulation (PTNM) for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, urinary frequency, and urge incontinence. Hence, the trend for treating incontinence is moving towards minimally invasive techniques.

Although implants are considered to be a safe it poses some of the risks such as infection at surgery site or pain at the site of implantation, bleeding, electrodes changing position, technical problem in the device such as battery failure or leakage, numbness, undesired stimulation, scar tissue formation, development of resistance to stimulation over a period of time. On the other hand, factors such as unfavourable reimbursement scenario, the risk associated with procedures and availability of alternate treatment options is hampering the adoption of this technology.

Some of the companies related to this segment are Torax Medical Inc. (U.S.), MyoPowers Medical Technologies (France), Reinhard Becker Medical (Germany), Medtronic (Ireland), Zephyr Surgical Implant (Switzerland), Coloplast (Denmark), Betatech Medical (Turkey), Swing Technologies (France), Johnson & Johnson (Ethicon) (U.S.), Boston Scientific (U.S.), Abiss (Switzerland), Caldera Medical Inc. (U.S.), Axonics Modulation Technologies (U.S.) etc.


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