Since 1920, women have been managing stress urinary incontinence with absorbent products. Kimberly-Clark invented cellulose wadding, which replaced cotton and gauze on the battlefields of World War I. Nurses were the first to recognize its potential in aiding menstruation and with all certainty urinary incontinence. After the war, a brand was created to convey its cotton texture like feel, hence Kotex—meaning cotton texture—and a whole new product category was created.

It wasn’t until the early 1990s that a product was created specifically for incontinence—primarily stress urinary incontinence. Poise from Kimberly-Clark contained SAM.

Since then there have been many new brands, shapes and sizes—variations off the same theme.

A Paradigm Shift. Stop The Leaking Before It Starts
Since 1920, companies have been working on absorbing urine. But what if you could prevent stress urinary incontinence in the first place? Three companies are working to do just that—Kimberly-Clark, a British company called Femeda and Solace Therapeutics which has a device in clinical evaluation.

Poise Impressa
Poise Impressa is a pessary. Kimberly-Clark refers to them as ‘bladder supports.’ I agree with Kimberly-Clark that bladder supports is a much better descriptor. Poise Impressa is a non-absorbent device that is inserted like a tampon and then expands and puts pressure on the urethra to help leaks from occurring in the first place. Unlike traditional pessaries, you don’t need a doctor’s visit. They’re sold in stores in the incontinence section. Kimberly-Clark introduced them into a Kansas City test market during June 2014. The purpose of the test was likely to check safety, product and marketing strategy.

During early February, K-C’s CEO Tom Falk said he hadn’t seen the numbers yet but heard they were doing well. My guess is they may be expanded during the summer. Some women that tried them said they were challenging to remove. The uncovered silicone support looks a little like Nazi tank trap used on the beaches of Normandy during World War II.

Femeda and the Pelviva Pelpon
What is a Pelviva Pelpon? The manufacturer describes it as the world’s first pelvic floor exerciser. A woman inserts it for 30 minutes and it pulsates and over time, strengthens her pelvic floor. It’s been in development for more than 10 years. The name, Pelviva Pelpon comes from ‘pelvic + alive’ combined with ‘pelvic tampon.’ A little play on words like Kotex (cotton texture).

It’s similar in size to a tampon. Some women said it felt very strong and uncomfortable at first, but after three or four pelpons, the pulses felt much more comfortable. It may be a bit like getting used to contact lenses. Each pelpon ‘pulses’ for 30 minutes with 10 seconds in a ‘work’ cycle and 10 seconds resting so a woman feels an on again, off again pulsing.

It turns on by activating the purple pull tab which delays the pulsing effect for 10 seconds, giving women time to insert it.
The intensity is gradually increased over the first few cycles until a level is reached that produces an electrically induced contraction of the pelvic floor muscles.

Each pelpon is single use and disposed of after the 30-minute treatment period. This reduces issues with infection. It is removed via a string.

The electrode is made of soft, expandable foam that is comfortable to use during a variety of day to day tasks and is disposable. It can be worn sitting, standing, lying down or walking. Because it’s easier to use, the company believes women may be more likely to use it to the end of treatment.

Other facts about Pelviva Pelpon include:
• Manufactured by Femeda, Ltd, a U.K. company located at Long Marston, York.
• Introduced into the U.K. market September 8, 2014, following a successful 30-woman user trial. Further expansion is expected.
• They also conducted a clinical trial by Wellcome Research in 2010 with 123 women where 84% noticed an improvement in reductions and frequency (similar to Poise Impressa).
• Using one every other day can result in improvement within 14 days.
• 18% of women as young as 25 admit they’re worried about bladder leaks during exercise.
• New patent application filed with a publication date of October 1, 2014 - GB1414695.5.
• Pricing per pelpon ranges from $10.38 each (a 2-count sample pack) to $6.92 each in the 30-count pack.

Solace Therapeutics
Solace Therapeutics is an emerging women’s health company focused on a revolutionary non-surgical office-based treatment for unexpected bladder leaks, the primary symptom of female Stress Urinary Incontinence (SUI). SUI, the most prevalent form of incontinence among women, affects an estimated 15 million adult women in the U.S.

Unfortunately, due to the lack of acceptable treatment options, most women choose to manage their SUI by utilizing absorbent products such as protective pads. Solace is dedicated to improving the quality of life for women whose daily life is disrupted by their incontinence.

The Solace Bladder Control System is a technology that addresses an underlying cause of stress urinary incontinence; the inability of the bladder to store urine during normal everyday physical activities without sudden increases in pressure. The Solace Bladder Control System is a non-surgical alternative to involuntary urinary leakage. The product is a small, lightweight device (about the size of a quarter) that floats within the urinary bladder. The balloon is designed to eliminate or reduce involuntary urinary leakage. It acts as a “cushion” to reduce the temporary pressure changes in the bladder that cause urinary leakage.

It is a novel, non-surgical treatment alternative for stress urinary incontinence. It behaves like a “cushion” in the bladder during moments of increased abdominal pressure by absorbing sudden pressure changes within the bladder, reducing or eliminating urine leakage.

As of August 2014, Solace enrolled 220 patients in a controlled, randomized clinical trial in 20 cities to evaluate the safety and effectiveness of the Solace Bladder Control Balloon. The Solace Bladder Control Balloon has already been evaluated in two controlled, randomized trials in the U.S. and Europe. In the U.S., over 200 women were enrolled. Results have been published in The Journal of Urology, Vol. 190 No. 6, 2013. “A Randomized, Controlled Trial of a Novel Intravesical Attenuation Device for the Treatment of Stress
Urinary Incontinence.”

The balloon is intended to remain in the bladder for up to one year and then be removed in a five-minute office visit. The website includes a list of cities where the trial is being conducted and an online screening survey to determine study eligibility.

What about P&G and SCA?
P&G had entered into an agreement with an Israeli company investing up to $100 million behind a similar device to Kimberly-Clark’s. They pulled out at the last minute for unknown reasons. Nothing else is known about their intentions within this space.

SCA is focused on protecting its current absorbent brand TENA from the introduction of P&G’s Always Discreet which has already achieved a 7% dollar share of the category in a handful of months in the U.S. and U.K. We are not aware of any developments by SCA in the ‘SUI prevention’ space.

Tom Wilson is the co-founder and president of The CareGiver Partnership and managing partner of CenterBrain Partners, Inc. He consults in the personal care space with investment houses, equity firms, suppliers of raw materials to the industry, market intelligence firms, startups and others. You can reach him at tomw@caregiverpartnership.com or at 920-886-8162.

Wilson has competed in personal care products across a wide range of categories including detergents, cleansers/cleaners, bar soap, dish liquid, baby diapers/pull-ups/wipes, adult diapers, and feminine care at both Colgate-Palmolive and Kimberly-Clark.