The Male Urinary Incontinence Market
It is estimated that five million American men have urinary incontinence with the North American incontinent market, excluding diapers, totaling $4.6b [viii, ix] The vast majority of incontinent men will live with urinary incontinence every day for the rest of their lives. Those affected are subjected to embarrassment and social isolation as well as the unhealthy use of diapers, while caregivers have the burden of hours of messy cleanup.
There are many conditions and causes of urinary incontinence, which occurs more often as we age; however, it is not caused by and should not be considered an expected consequence of growing older. Incontinence is also a common secondary effect of spinal cord injury (SCI), traumatic brain injury (TBI) and Post Traumatic Stress Disorders (PTSD)—injuries that predominantly affect young men, many of them military veterans.
Absorbent products, more often known as diapers and pads, are bulky, uncomfortable, and undignified—they emit an unpleasant smell. Having to carry extras at all times is not only inconvenient, but also impedes independence.
Each year nearly 200,000 men are diagnosed with prostate cancer, almost all of whom will experience urinary incontinence after surgery. In fact, 70 percent of respondents in a patient survey identified urinary incontinence as the side effect they were most concerned about prior to prostate cancer treatment. While most heal within a few months, patient surveys indicate that up to 46 percent of prostate cancer survivors report dealing with ongoing urinary incontinence issues. Other findings include:
- 23.6 percent reported constant or near-constant dribbles and leaks
- 46.2 percent reported occasional leakage (stress incontinence)
- 30.1 percent reported frequency (urge incontinence)
- 9.6 percent reported a complete loss of bladder control
- Several reported multiple types of incontinence
- 41 percent indicated that their side effects were worse or much worse than they had expected
- Although 60 percent indicated their doctor was aware of their incontinence, patients do not appear to be offered better solutions. As a result, 32 percent use diapers and 40 percent use nothing at all.
Competitive Products for Male Urinary Incontinence
Absorbents include pads and diapers that are made of hydrophilic materials for absorbing urine, and a hydrophobic external layer for holding the moisture inside and preventing leaks. They are relatively cheap, readily available and easy to use. However, the negative aspects are a pervasive ammonia smell, visibility under clothing, and the need for extra supplies at all times.
Up to 25 percent of absorbent users will develop Incontinence-Associated Dermatitis (IAD)[i]. In as little as five days of continuous use of absorbents, the resulting increase in sweat production and compromised skin barrier function[ii] can cause IAD. In addition, continuous absorbent use is associated with an increased risk of pressure ulcers[iii].
In a 2002 survey, 13 percent of men reported incontinence. After adjusting for socio-demographics, living situation, and co-morbidities, continentmen received 7.4 hours per week of care, incontinent menwho did not use pads received 11.3 hours, and incontinentmen who used pads received 16.6 hours.
The Foley catheter appeared on the market in 1934 after Frederick E.B. Foley experimented with differentcatheters of the time and different methods of securing the catheter. He came up with the idea of attaching a balloon-like device to the end of the catheter. The device would then be able to be placed and then inflated from the outside.
Other than material, the Foley catheter design remains largely unchanged as do the side effects. Catheter-associated urinary tract infections (CAUTI) account for at least 40 percent of all infections acquired in hospitals, costing the healthcare system more than $2 billion a year[iv]. The risk of developing a CAUTI increases 5 percent each day a catheter is in place, with a 100 percent infection rate[v] for long-term use.
Long-term indwelling catheterization is also associated with a heightened risk of bladder cancer. An estimated 10 percent of individuals who use an indwelling catheter for 10 years or more will develop bladder cancer[vi].
Condom catheters seal to the shaft of the penis using an aggressive acrylic adhesive similar to duct tape and have to be removed each time you need to intermittent catheterize. Condom catheters soak the penis in urine, increasing the likelihood of skin breakdown and UTIs. Up to 15 percent of users will experience skin breakdown, and 40 percent of long-term users will get a UTI[vii]. Condom catheters frequently dislodge, causing users great embarrassment.
[i] Gray, M., “Optimal Management of Incontinence-Associated Dermatitis in the Elderly,” American Journal of Clinical Dermatology, 2010:00 (0).
[ii] Aly, R., Shirley, C., Cunico, B., et al, “Effect of Prolonged occlusion on the microbial flora, pH, carbon dioxide and transepidermal water loss on human skin,” Journal Investifative Dermatology, 1978; 71 (6): 378-81.
[iii]BioDerm estimate, 2005, based on Pajk, Marilyn Pressure Sores. Merck Manual of Geriatrics Section 15, Chapter 124. Internet Edition provided by Medical Services, USMEDSA, USHH. Published by Merck and Co. Inc, 2000
[iv] Kunin, Calvin, “Nosocomial Urinary Tract Infections and the Indwelling Catheter: What is New and What is True?” Chest 2001; 120: 10-12.
[v] Sanjay Saint, MD, MPH and Benjamin A. Lipsky, MD. “Preventing Catheter-Related Bacteriuria: Should We? Can We? How?” Archives of Internal Medicine. 159 (26 April 1999): 800-808.
[vi] Shokeir, A., “Squamous cell carcinoma of the bladder: pathyology, diagnosis and treatment,” British Journal of Urology International, 2004; 93: 216-220.
[vii] Ouslander, J., Greengold, B., Chen, S.,, “External Condom Catheter Use and Urinary Tract Infections Among Incontinent Male Nursing Home Patients” Journal of the American Geriatrics Society, Vol. 35, 1987; And, Golji, H., “Complications of External Condom Drainage,” Paraplegia (19), 1981.