|Pessaries have been around since 300 B.C. This ancient one was made out of wood.|
What Is a Pessary?
A pessary is a device used to help control stress-related incontinence. It is placed in the vagina to support the uterus and bladder or rectum. By pressing against the wall of the vagina and the urethra, it helps to decrease urine leakage. Although it doesn't cure problems like pelvic organ prolapse, it can help manage them and slow the progression.
|This drawing shows where a pessary is placed.|
These reusable devices are typically available in different sizes and fitted in a doctor's office. Many women who use pessary devices find their symptoms improve and they experience added support and increased tightness in pelvic muscles and tissues. There are entire websites dedicated to such devices.
|Reusable pessaries come in many shapes and sizes.|
History of the Pessary
The use of pessaries dates back prior to the days of Hippocrates. Throughout the centuries, remedies such as honey, hot oil, wine, and fumes were used as treatment for pelvic organ prolapse, urinary incontinence and other ailments, as were mechanical methods such as leg binding. In the Middle Ages, linen and cotton wool soaked in various potions were used as pessaries.
For a time, cork and brass pessaries were used, but were soon replaced with rubber. Modern day pessaries are made of non-reactive silicone and come in various designs and sizes.
Pessaries to Reduce Stress Urinary Incontinence
Stress urinary incontinence (SUI), the most common type of urinary incontinence, refers to the involuntary loss of urine resulting from abdominal pressure that can occur during exercise, coughing, sneezing and laughing. SUI, which affects 13 percent of men and 53 percent of women over age 50, represents nearly 80 percent of all incontinence. Consumers spent $19.5 billion in 2000 to treat SUI.
When stress incontinence occurs, it is usually the result of the abnormal descent of the urethra and bladder neck below the level of the pelvic floor. Many women wear feminine care pads, incontinence pads or disposable pull-on underwear in order to deal with incontinence. Some resort to surgical procedures.
Pessary devices are known to help relieve involuntary urination in women. Such devices provide compression and support to the bladder. Typical pessary devices are large in diameter and may elastically expand, inflate or unfold to provide compressive action during use. They may be uncomfortable and/or require the user to activate or operate the device prior to or upon insertion.
Although there are specialized products available for this purpose, most only are available by prescription must be properly sized, physically inserted and/or adjusted by a medical doctor for them to correctly perform. These are cleaned after removal and reused. For all these reasons, pessaries are not very popular.
Poise Impressa Test Results
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.
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.
What Are the Risks to a Woman?
While there are benefits from reusable pessary devices, they are not without risks, which often are the result of an ill-fitted or misworn device. A woman may need to change the shape or size of her reusable pessary after her initial fitting.
Risks include sores, bleeding, wear on the vaginal wall, an opening or fistula between the vagina and rectum, and bulging of the rectum against the vaginal wall.
Why Would a Woman Choose to Wear a Pessary?
There are risks with pessary devices, so why would a woman choose this option?
It can also be a good way to test and see what the effects of surgery for pelvic organ prolapse will be on urinary symptoms. Because it mimics what the surgery will do, you can determine if the impact is great enough to warrant the risks associated with surgery.
There can be some side effects such as increased vaginal discharge or discomfort during sex, but most can be helped or eliminated with a different style, size or shape of pessary. Pessary devices can be found in rubber, plastic, silicone, as an inflatable, etc.
A woman should talk with her healthcare professional to see if a pessary device (reusable or disposable) is right for her.
Unmet Consumer Needs
Despite being in existence for so long, pessaries have never caught on, even during the modern era of consumer products like Tampax tampons and Kotex. Having designed and marketed both feminine care and incontinence products for more than 30 years, to our knowledge there has never been a consumer-friendly, disposable pessary.
The major unmet consumer need is a comfortable, single-use, disposable device. It should be uncomplicated, user friendly, small in size, easy and comfortable to insert and remove, and, most importantly, effective at managing incontinence. Such a device should be safe to use daily, be discreetly transported, and easily used and disposed of when away from home. A product with these attributes could shift the use of incontinence products from ordinary pads and pull-on underwear. However, there may be a perceived safety hurdle — read more on that below.
P&G Test of a Disposable Pessary
In 2011, P&G published the results of a study of a new pessary design from an Israeli startup named ConTipi Ltd. 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.
|OTC status was granted on Aug. 27, 2013.|
Regulatory Approval Granted in the United States
ConTipi was granted OTC regulatory approval on Aug. 27, 2013, allowing it to market the product as a class II medical device, as a disposable consumer product intended to be worn for 8 hours to help manage stress urinary incontinence.
A Pessary With a Protuberance
On April 10, 2014, P&G was granted a patent on a a pessary device having a top, a base, a length, a longitudinal axis, and a hollow interior. The pessary device's hollow interior contains a protuberance. It is assumed that the protuberance feature is integral to the design, since it is mentioned 100 times within the patent. This terms refers to something that bulges out or projects from its surroundings. Another patent for a carrier mold to produce a shaped tampon was granted May 14, 2013.
|Protuberance is mentioned 100 times in the patent.|
|The pessary is inserted using a tampon-like applicator.|
Could This be Rely II?
We earlier mentioned there may be a hurdle to introducing pessaries. This risk is fear of unknown health risks. After all, this is an internally worn device.
Beginning in 1975, P&G began testing Rely tampons in Rochester and Fort Wayne. The test itself was reported as being "controversial." Rely was unique in that it used new materials that had undergone extensive safety testing. The advertising tagline: "It even absorbs the worry!" P&G recalled Rely in September 1980 after the Centers for Disease Control released a report that summer explaining the bacterial mechanisms that to toxic shock syndrome (TSS) and that Rely tampons were associated with TSS more than any other tampon. The recall cost P&G over $75 million.
|Rely was recalled in September 1980 due to toxic shock syndrome concerns.|
While pessaries do not absorb, the new disposable types have not yet been used by millions of women. No one knows how safe these internally worn devices will be, and overcoming potential safety concerns may prove to be an obstacle to acceptance. The generation of women who may recall TSS was brought to them by P&G and Rely are now using incontinence product and may be reluctant.
The other important influence may be the medical community. There is little incentive for health care providers to recommend a new product form that is unproven.
A Product Design with Significant Potential
Single-use, disposable pessaries have significant potential because:
- They're targeted to women with SUI, which represent the core of incontinence episodes.
- They look normal; a woman places them just like she does a tampon.
- They look modern and innovative, not like an ordinary pad or pull-on underwear.
- The target market is growing; 5,000 baby boomer women are turning 65 every day, and this will continue for the next 20 or more years.
Pessaries don't absorb like tampons. Instead, they provide mechanical support of the sagging muscle to help reduce leakage.
Potential Effect on Sales of Incontinence Pads and Pull-On Underwear
If a significant number of women move to this new design, pads and pull-on underwear sales could be detrimentally affected. However, two aspects could inhibit trial: pricing and safety concerns.
On a per-product basis (pessary or bladder control insert vs. pad), Pessaries cost 5 times more per product. Women on average use two pads per day. Pessaries (like Poise bladder inserts) are intended for use for 8 hours. To economize, women may use a pessary during the day or when away from home, and pads or pull-on underwear while sleeping.
Alternatives to the pessary for women are using ordinary absorbent products, which have been in existence since the 1920s (think Kotex pads), physical therapy, behavior modification, pharmaceuticals, and vaginal and urethral inserts. These alternatives have poor compliance rates and limited efficacy.
Current reusable pessaries, which are fitted in a doctor's office, are associated with vaginal erosion, foul vaginal odors and other complications associated with prolonged use. That's why a disposable option is consumer preferred.
Pessaries. P&G's Next Incontinence Frontier?
Poise Impressa. A Game Changer.
Introducing Even More Consumer Confusion
Consumers are terribly confused when it comes to buying incontinence products, especially those who are new to the category. Kimberly-Clark, makers of market leading brands Depend and Poise, claim that people who buy incontinence products for the first time waste an average of $130 on trial and error until they find a product to best meet their needs. That’s about 10 bags of products that can’t be returned once opened.
This confusion is caused by lack of naming standards, absorbency standards across and between brands, confusing product descriptors and lack of expert advice. Here is a good explanation of what is causing this confusion That's why The CareGiver Partnership developed The Incontinence Product Finder to help consumers sort through over 650 globally sourced incontinence products quickly and easily and then avoid the cost mistake of buying the wrong products.
The introduction of a new product segment (Pessaries or bladder support inserts) with new brands and features will further add to the existing consumer confusion.
Kimberly-Clark Patent Filing Activity
Kimberly-Clark has a long history of patent filings around pessaries dating back as far as 1927.
Some of the language used to describe such products states that the insert may be formed from a variety of bio-compatible materials and may be formed as a solid or semi-solid mass of a compressible, resilient, bio-compatible material that allows the insert to deform and to substantially conform to the shape of the object deforming the insert. Alternatively, the insert may be formed such that the insert has a thin wall that defines an outer surface and an inner surface.
Many of its more recent patent filings related to tampon-like devices make mention that "it will be readily apparent that the pledgets and tampons can also be used as any other suitable vaginal insert, such as a pessary."
On May 29, 2014, Tom Falk, CEO of Kimberly-Clark (#KMB) made a comment at the 2014 Sanford C. Bernstein Strategic Decisions Conference that "... we’ve just launched the new Poise microliner and have got some new innovation and new product that is coming there."
As predicted in June, Kimberly-Clark introduced a Poise-branded pessary (Poise Impressa) in September to extend the brand franchise and compete against the P&G Always Discreet line. I was surprised they didn't announce this ahead of P&G's August 1 announcement so it wouldn''t appear to be reactionary.
|1927 Kimberly-Clark pessary patent.|
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 the health concerns (Rely, Olean/Olestra).
By Tom Wilson, Co-Founder and President of The CareGiver Partnership, a national direct to consumer retailer of over 550 incontinence products, globally sourced. Tom is also Managing Director of CenterBrain Partners, Inc. specializing in positioning new products. CenterBrain has offices in the United States and China. You can reach me at email@example.com or 920-886-8162.