Pacey Medtech, based in Vancouver, Canada, has developed the Pacey Cuff, a urethral control device for urinary incontinence in men, post-prostate cancer treatment. Treating prostate cancer can sometimes lead to urinary incontinence, which can have significant consequences for patient confidence and comfort. The psychological impact of incontinence can be enormous, and can affect people’s ability to work and socialize.
The Pacey Cuff has been proposed as a solution to the issue. It fits around the penis, and applies pressure to the urethra to prevent urine leakage. However, what makes the device different from traditional penile clamps is that it doesn’t cut off blood flow, and applies pressure only to the urethra. Traditional clamps can cause discomfort and ischemic pain by blocking blood vessels in the penis. The company claims that the new device eliminates those issues, and that it can provide 24-hour protection against leakage.
You can see a video demonstrating the device below
Medgadget had the opportunity to ask Dr. Jack Pacey, Pacey Medtech CEO, and Dr. Daniel Rapoport, a urologist and clinical instructor at the University of British Columbia’s Department of Urological Sciences, some questions about the product.
Conn Hastings, Medgadget: How common is urinary incontinence after prostate cancer treatment? What consequences can this have for affected patients?
Dr. Jack Pacey: The incidence range is 5–30% and the average incidence of long-term incontinence is 11%. The consequences include usage of pads and disposable diapers, 24-hour urine leakage and odor. The problem also means expense purchases of disposables, excessive land fill dumping and the need for surgical implants and secondary operations. There are also spousal and family impacts and reduced social connectedness.
Dr. Daniel Rapoport: Incidence varies widely in the literature. It is very common to have incontinence immediately after prostate cancer surgery with a gradual improvement during the 1st postoperative year. About 10% of patients have persistent urinary incontinence after 1 year. After radiation therapy, incontinence is initially rare, but incidence increases with time and especially if procedures are required to manage complications of radiation, such as obstruction from scarring.
In addition to costs, emotional/psychological and social impacts, incontinence can lead to chronic dermatitis (skin inflammation) and even ulceration and open wounds.
Medgadget: How did you become interested in this area, and how did the product come about?
Dr. Pacey: This area is of interest because I am a serial medical device inventor and this topic required my special skills as a Vascular and General Surgeon to protect blood supply through design of the product. This is a large unmet need because the numbers of patients internationally are very large.
Dr. Rapoport: I’ve been lucky to connect with Jack and observe his process of medical innovation. Fortunately, he has become interested in improving solutions for urinary incontinence. which is a major area of clinical interest for me. In addition to providing surgical solutions for this problem, I have the chance to develop and improve non-invasive options for these patients.
Medgadget: What are the drawbacks to traditional penile clamps?
Dr. Pacey: Traditional penile clamps present a risk of damage to the penis from repeated ischemic tissue insults. The risk of gangrene can be present if the standard old designs are left in place, particularly in medicated patients or those with cognitive impairments. Traditional clamps cause the patient to urgently need to stop activities such as driving and find a facility to release the clamp and enable blood to return to the penis.
Dr. Rapoport: In my practice I have observed that most people do not tolerate the traditional clamps due to discomfort and skin irritation. For the traditional clamps to be effective they need to provide adequate urethral compression and in their current format this inevitably involves cross clamping of the penis with significant pressure on the penile skin and underlying blood vessels.
Medgadget: So, how does the Pacey Cuff work, and how does it avoid the drawbacks of penis clamps?
Dr. Pacey: The dorsal or top part of the penis has the major blood vessels such as the dorsal artery and veins. The fenestrated hood distributes the pressure over a larger area of tissue resulting in lower average pressure. The Urethral compression component on the lower area is also a larger surface area with lower pressures. Thus, pulse flow continues in the penis and doppler or pulse oximetry testing can demonstrate the vascular protective effect.
Dr. Rapoport: The Pacey Cuff has a very simple design based on the relevant penile anatomy that allows the device to focus compression on the urethra (and decrease leakage as a result) without cross clamping the remaining penile blood vessels, nerves and skin.
Medgadget: Is the product comfortable and easy to use?
Dr. Pacey: The product requires some teaching and adjustment. The correctly sized and applied device is comfortable for use and will easily be applied for 2–3 hours between release actions. There is also a conformal design that is easy to release in typical urinal environments and reapplication is discrete and easy with convenient numbers to be sure that adequate pressure is applied without over pressure.
The device is useful for active users like pilots, truck drivers, skiers, swimmers, and outdoor workers. There is also an unmet need in nursing home environments and postoperative care before normal function occurs.
We foresee the use of our patented pulse oximetry device as a valuable addition to nursing home care to reduce the occurrence of bed-wetting, and the resultant odor and skin exposure to soiled linen for long periods. This can average at over 200 minutes between nursing visits and is detrimental to quality of life for incontinent seniors. Incontinence is a major cause of extended care admission to hospital. We would like to impact this serious problem.
Medgadget: How has the product been received by users so far?
Dr. Pacey: The product is gaining gradual acceptance and users reorder the device. The market is beginning to realize the unique advantage of the device and urologists are increasingly recommending the device.
Product evaluation and improvement has been continuous and now the design is stable. Product extensions are planned for night use and supportive products will be introduced so that our Pacey Cuff becomes a platform technology.
Dr. Rapoport: In my experience, users have been very receptive. They find the idea of a non-invasive solution to a very bothersome problem attractive. I have several patients who have used the Pacey Cuff. I have not known of anyone to have developed a complication from its use and all have been able to use the device for long periods of time, comfortably. Several of these patients have found the device to be satisfactory in effect, and use the device as a long-term solution for their incontinence.
Link: Pacey Medtech…