Poise Impressa - A Game Changer. Updated October 3, 2015

Prevents bladder leaks rather than absorbing them.
Poise Impressa has been in test in Kansas City since September 2014.
Kimberly-Clark is rolling this new product nationally with the first couponing support on September 13. It is already in many stores including Walmart and Target.

We believe Impressa will create a new segment of non-absorbent over the counter devices that use mechanical means to prevent, not absorb stress urinary incontinence (SUI).
 
Based on results from the Kansas City test, we believe Poise Impressa revenue could grow to $75 million over time.  The trial kit will initially be the key revenue driver as women identify the correct size which best fits their anatomy.
We also believe the manufacturer will invest heavily against this portion of the Poise brand for the first year or so. 
In limited consumer testing, we've heard some women find it uncomfortable to remove.  Being able to collapse the posts upon removal would be good.  The device does resemble a tank trap used by the Nazi's in Normandy.
In June 2014 we predicted that Kimberly-Clark would introduce a line of pessaries branded as Poise Impressa bladder supports.  The test market introduction occurred in September into the Kansas City market.  This followed the acquisition of ConTIPI, an Israeli company in 2012 for $90 million+.

To get an in-depth understanding of the history of pessaries as well as Proctor & Gamble's (#PG) developments in this area read Pessaries:  P&G and Kimberly-Clark's Next Incontinence Frontier.

What is Poise Impressa?
It is a non-absorbent device that is inserted like a tampon which expands and puts pressure on the urethra to help leaks from occurring in the first place.




How Are Traditional Pessaries* Different?
  • They have to be fitted by a healthcare provider
  • They're rigid and have fixed dimensions.  Impressa is made of flexible silicone
  • They have to be continuously handled, washed and reinserted
  • They are prescribed and monitored by a healthcare professional
*Kimberly-Clark refers to these as IVID's - inter-vaginal insertion devicePackage labeling refers to them as Bladder Supports.

Features & Benefits 
  • Unlike a pessary, it is available over the counter without a doctors visit or prescription.
  • Its been cleared by the FDA.
  • It looks like a tampon, but it isn’t. 
  • Its a non-absorbent bladder support made of a soft, flexible silicone enclosed in a non-absorbent covering. 
  • It’s inserted and removed the same way as a tampon, but works very differently. 
  • It can be worn for up to 8-hours.
  • A woman can use the bathroom while its inserted.
  • It has a smooth and rounded tip tampon-like applicator for comfortable insertion.
  • The applicator has finger grips for better control.
  • Its discarded in the trash.  You don't reuse or flush it. 
  • A woman purchases a sizing kit which contains two of each of three sizes.  There are $4.00 offers online netting trial down to $16.98. She starts with Size 1 and progresses to Size 2 or 3 if she feels like she needs more support to help stop leaks.
  • The three sizes... 1, 2 & 3 are for low, medium and high support.
  • There are 10 supports in the carton.
  • A box of 10 retails for $16.99 or $1.70 each at Walmart.  This compares to $.30 for a Poise pad maximum pad retail price at Walmart.  Therefore, Impressa costs at least 5 times more than comparative Poise pads.  This is dependent on how often the pad is changed (every 4 or 8 hours is typical).  It is recommended the Impressa product be changed every 8 hours.
  • Sizing is based on internal fit; not how much a person leaks or weighs.
  • They're not intended to be used if pregnant or menstruating.
  • Most common side effects are mild discomfort and spotting.  This usually goes away after a week.
  • Toxic Shock Syndrome (TSS) – hasn’t been associated with this product.
  • A woman can swim while wearing the product.  Or do any physical activity.  
  • Environmental -with the potential for millions fewer pads going into landfills, Impressa provides an environmental benefit as well.
When inserted, the support 'springs' into action.  It is removed like a tampon with a string.







While there are three sizes, they appear similar.



Visually Similar to P&G's 2011 Test Product
Pessary tested by P&G in 2011. 




P&G and Kimberly-Clark Bidding War for ConTIPI
In 2011, P&G published the results of a study of a new pessary design from an Israeli startup named ConTIPI Ltd. which was founded in 2002.  P&G reportedly agreed to acquire the company for up to $100 million on Sept. 16, 2010, and then, a month later, rescinded the offer. They did agree to continue its partnership to distribute ConTipi's products as a pilot in several countries.

P&G, in conjunction with a Cincinnati testing facility and local doctors, published a report of a study they did on the design. The product is a single-use, disposable product that has a resin core (flexible silicone rubber core) providing tension-free support whenever pressure is trans­ferred from the abdominal cavity to the pelvic floor. The core is covered by a non-woven mesh. Both are contained within a smooth, small-diameter applicator similar to those used for tampon inser­tion. As pictured below, the device is attached to a tampon-like string for removal.

A study with 57 women demonstrated that the device significantly reduced both the number of incontinence episodes from stress urinary incontinence (while coughing, laughing, lifting) as well as less leakage and a self-reported improvement in quality of life. The latter is the real benefit in that it helps women enjoy life more.

Another study, published in May 2008 titled Efficacy and Safety of a Novel Disposable Intravaginal Device for Treating Stress Urinary Incontinence showed that the intravaginal device was easy to use, well-tolerated, and effective in reducing SUI.  Source:  PubMed.gov

ConTIPI, Ltd., was founded by gynecologists Dr. Ilan Ziv and Zeev Bronfeld.  The bladder insert was sold to Kimberly-Clark in April 2012.  The reported price tag was $90 million.  The company also negotiated a further payment of $55 million subject to meeting unspecified sales targets for the device from the closing of the deal.

P&G missed a major opportunity when they let ConTIPI slip through their fingers. If Impressa takes off like many believe it will ($75 million retail sales), P&G will need to enter with a competitive response or be left out in the cold like they were when K-C first introduced Pull-Ups training pants.  I'm sure they are working on ways to design around Impressa's IP.

Other Developments

Solace Bladder Control Balloon
 
Success bladder control balloon absorbs pressure changes in the bladder, reducing or eliminating urine leakage.

This area is generating a good deal of attention by large organizations as well as start-ups. One such start-up is Solace Therapeutics and their Solace Bladder Control Procedure.  It is a novel, non-surgical treatment alternative for stress urinary incontinence (SUI).  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.

In August 2015, Solace completed enrolling patients in a controlled, randomized clinical trial to evaluate the safety and effectiveness of the Solace Bladder Control Balloon. There was significant interest among women with 105,000 visiting the site to learn more. The CareGiver Partnership worked with Solace to help make women with SUI aware of this clinical study.  Approximately 220 women will be eligible to participate in 20 centers throughout the U.S. The Solace Bladder Control Balloon (SUCCESS) 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 5-miute office visit.  To learn more about the SUCCESS Trial visit; www.stopsui.com. The site includes information about the study and the product - branded Vesair.

Pelviva Pelpon
What is a Pelviva Pelon?  The manufacturer describes it as the worlds first pelvic floor exerciser.  A woman inserts it for 30 minutes and it pulsates and over time, strengthens her pelvic floor.  Learn more here.




 Poise Impressa - Stop Bladder Leaks Before They Happen

But Does Poise Impressa Actually Work?
In an FDA approved study size of N=50 women wearing Poise Impressa who had severe SUI, it was shown that:
  • 94% experienced a leak reduction of 70% or more.
  • It takes about a week for full effectiveness to be demonstrated.  After a week, wearers experienced leakage reduction of 86%.  The take away is... give it a week at least.
  • 92% of women claimed they felt dry.
  • When asked about coughing, laughing, sneezing, jumping, lifting, walking, running or going to the gym 50-90% of women expressed a lack of confidence they could stay dry during these activities.  By the end of the study this dropped to about 10%.  In other words, about 90% of women were confident they would stay dry.
  • 92% of women said their quality of life had significantly improved - physical, the abiliyt to travel, to socialize and emotional.
  • The real consumer benefit of Poise Impressa is an enhanced quality of life.
  • Currently, the Poise Impressa website contains 33 reviews by women with an average rating of 4.7/5.  Therefore, among women responding, they really like the product.  On Amazon there are 30 reviews with an average rating of 3.5/5.  Combined, the average review is about 4/5 - pretty good for such a novel new product.

How It Works
The core is composed of flexible medical-grade silicone with anchor and support poles, and is designed to respond to movement while staying in place. As it supports the urethra, each pole functions independently to adapt to vaginal structural variability in order to effectively generate counter-tension under stress.

A soft, non-absorbent polypropylene cover surrounds the core, stretching between the support poles to act as a tension-free sub-urethral sling without obstructing urinary flow or vaginal secretions.




Why was Poise Impressa Test Marketed For a Year Before National Introduction?
The days of lengthy test markets of consumer products faded many years ago.  So why did Kimberly-Clark tip their hat to P&G, SCA and others?  There are three reasons:
    It could be that because this is a new to the world product design, the manufacturing process hasn't been optimized - its made in Mexico.  This occurred in 1989 with Pull-Ups training pants which resulted in a multi-year roll out as a very complicated process was figured out.  Pull-Ups was the first 3D disposable product manufactured at high speed.

    They may have wanted to error on the side of caution, making sure there were no safety concerns.  Toxic Shock Syndrome has long been associated with tampons and Impressa is an internally worn device, albeit, non-absorbent.

    Kimberly-Clark is also connecting with appropriate medical community members as well as other logical recommenders of such a product form.  This may be a product that takes more time to build due to the need to change consumer behavior (according to CEO Tom Falk).  To this point, a woman might use a tampon for 4 to 6 days.  With Poise Impressa, she's using it everyday.  That is asking her to change habits, usually a tough task in the world of consumer marketing.

    Early testing amongst a small base of women showed that removal could be a bit challenging.  Product expectation will have to be properly established.

    Kimberly-Clark is working closely with the medical community - Gynecologists and Urogynecologists to make sure they understand the product.  To that end they are a Gold Sponsor of The American Urogynecology Society (AUGS) meeting this October in Seattle. They don't expect doctors to recommend Impressa necessarily, but they want them to be well educated so they don't sabotage it either.  Its kind of a respect, out of deference thing.  

    We've all seen the ads on TV about lawsuits against the manufacturers of trasvaginal mesh for stress urinary incontinence (SUI).  J&J alone is facing 12,000 lawsuits.  Women are leery of risky surgery or taking prescription drugs which are expensive, of little value and had side effects.  Poise Impressa is a conservative and effective solution.

    They may have wanted to refine the marketing plan before a large national investment. 

Poise Impressa Helps You Get On With Life

Consumer Benefit
The high ground consumer benefit is enhanced quality of life.  The ability to stay active and physical without worry about leaking; the confidence to travel with family or friends and to socialize.  This could be summed up as 'Poise Impressa Helps You Get On With Life', a positioning similar to Depend in the early 1980's.   Stress urinary incontinence (SUI) facts...


37% of women are frustrated with SUI
40% say it makes them feel old

49% are embarrassed

51% with bladder leakage haven’t talked to anyone about it
65% of all U.S. women ages 35-65 have experienced bladder leakage at some point
66% experienced a leak after a cough
73% could feel more active if they could prevent leaks, rather than just absorb them
74% experienced a leak after sneezing
  
The Poise Impressa Bladder Leakage Survey was conducted online within the United States by Harris Poll on behalf of Kimberly-Clark between July 9 and July 13, 2015 among 1,008 women ages 35-65 who currently reside in the United States, including 663 women who have ever experienced bladder leakage.  If you would like to request a copy of the study and findings, email Raina Bahu in NY at Marina Maher Communications.

Game Changer
Poise Impressa, if marketed correctly, can change the basis of competition within the light end incontinence market - namely stress urinary incontinence or SUI.  The largest and growing segment of the category.  It adds an innovative halo to the Poise brand as being the category innovator and leader.

Poise Impressa also speaks volumes about Always Discreet being just another ordinary, absorbent product.  However, we believe that with Poise Impressa in the market nationally, P&G's will hasten their pessary efforts.

The big loser will be SCA (TENA brand) if they continue with their losing strategy. Their retail business has lost a tremendous amount of ground over the past year since the introduction of P&G Always Discreet.  They've hired an outsider, Michael Feenan as VP of Sales and Marketing reporting to the president of SCA Americas -- Don Lewis.  I wouldn't be surprised to see Mr. Feenan replace Mr. Lewis as results for SCA's TENA brand have been disastrous.  Mr. Feenan does however lack consumer products and personal care products expertise and a relationship with the mother ship of SCA in Europe.

Size of the Prize
The light end segment is approximately $500 million+ (excluding liners) in the U.S.  Poise share is 65% ($365 million including liners), growing at 8% annually.  Depending on the ability to market effectively (fast broad-scale trial), this new product could add $75 million in incremental sales to Kimberly-Clark's incontinence category share.  Based on IRI data, only a few percent of new products achieve $50 million in sales.  The key determinant of success now is execution - driving awareness and trial via broad scale media.

A key success driver is the ability to change consumer habits.  While women are familiar with wearing tampons, they need to be convinced that Poise Impressa (which doesn't absorb) will actually stop leaks.  It takes 5 to 7 days for a woman to experience the full effect of the product (assuming they've chosen the optimum size in the first place). 

Retail pricing for 10-count carton at Walmart is $13.97 ($1.40 each) or about 5 times the cost of the larger Poise pads.  If Poise Impressa delivers results like the tests have shown, women may eagerly replace their pads - Poise, Always, TENA and perhaps store brand.  While Impressa may cannibalize some of the Poise pad business, more will come from competitors.  That's why speed to market is so important.

Marketing Myopia
From a strategic perspective, I wonder why Playtex or Tampax (P&G) didn't introduce such a device.  This is a natural extension of their brands.  Its a bit like KFC missing 'Chicken Nuggets' to McDonalds or Kimberly-Clark missing out on Swiffer to P&G (K-C was #1 in non-wovens).  

Summary - Poise Impressa
  • Its a revolutionary, first to the world product that looks like an old friend (tampon)
  • It stops (most) leaks before they happen
  • Tests prove it significantly reduces leaks while improving women's quality of life
  • To date, its been shown to be safe
  • There are no (major) side effects
  • It doesn't interfere with a woman's daily activities - she can do anything and everything
  • Its by a trusted, #1 brand
  • Women have to change habits
  • Its expensive (we think the benefit will offset the cost)
  • Retailers will love it - its innovative, small in size and brings higher margins to the category
Further Reading

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Having competed against P&G since 1974 across a wide range of categories — including detergents, cleansers/cleaners, bar soap, dish liquid, baby diapers, adult diapers and feminine care — the introduction of pessaries will be very interesting, especially overcoming any health concerns (Rely, Olean/Olestra).

By Tom Wilson, Co-Founder and President of The CareGiver Partnership, a national direct to consumer retailer of over 650 incontinence products, globally sourced.  Managing Partner of CenterBrain Partners, Inc. specializing in positioning new products, services and organizations with offices in the U.S. and China.



 


2 comments:

Leslie Kernisan MD MPH said...

Thank you Tom for this very interesting post! This approach sounds promising, and it's nice that women are able to try this on their own.
I hope there will be additional studies of the efficacy and safety.

Anonymous said...

How do you address the dryness issue concerning insertion? No tampons, intercourse for about 20 years.

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