Incontinence Pad

What is an Incontinence Pad?

Incontinence Pad is a class I medical product that is designed to manage urine leakage and help with Urinary Incontinence. Each incontinence pad features an acquisition layer which promotes the first passage of urine through the inner core of the pad. The core usually also contains a super absorbent powder.Incontinence pads also feature odor technology that helps prevent the formation of odors and maintains a healthy skin pH. Generally, incontinence pads are made of soft, absorbent fabric that’s filled with a liquid-absorbing polymer. When urine touches the polymer, it becomes trapped,  keeping the skin clean and dry. The back of the pad consists of a waterproof layer that keeps leakage from passing through onto clothes. The following are the basic requirements of an incontinence pad:

• Ability to contain leakage
• Provides a discreet design
• Ability to contain smell
• Keeps the skin dry and reduces irritation
• Is soft and provides comfort to the skin

There are several manufacturers producing various kinds of incontinence pads depending on the type of incontinence. Some of the manufacturers include companies like Medline, Kimberly Clark, Tranquility, Protection Plus, Unique Wellness, Dry Comfort etc and following are some of the pads manufactured by these companies.

 

             Figure 1: Examples of Incontinence Pads

 

Part of the Pad	Material	Function
Surface material	polypropylene/polyethylene polyester/viscose.	Absorbs the liquid and keeps you dry and comfortable
Acquisition layer	Porous Material – Wood or polyester fiber	Moves liquid from the surface of the pad to the center
Absorbent core	Paper pulp and super absorbents for pads and panty liners. In some products, porous paper-based material is used.	Absorbs and stores the liquids.
Adhesive Strip	The adhesive strip consists of various polymers and synthetic resins.	The adhesive strip is essential for binding together the product layers and attaches the product to your underwear
Back sheet material	Polyethylene film	Extra Protection to prevent leakage
Fastening material	Polymer materials	Keeps the product in place
Elastic Material	Polymer materials	Provides comfort and ensures a good fit
Fragrance (certain products only)	Light perfume	Gives the product a fresh smell
Release Paper	Silicone coated paper	A paper that protects the adhesive on the back of the product

 

 

Disease State and Anatomical Site

Incontinence is described as the uncontrolled leakage of urine or feces from the body. It can affect people of all ages and can occur as isolated incidents or as a recurring condition. For some, it can be severe, whereas for others it can be comparatively mild or moderate. For most people, alongside the initial leakage, there are other issues that surface afterwards. These include things such as staining of clothing and odors. Because these are common occurrences for people with incontinence issues, they can seriously affect their confidence, mental well being and general quality of life. Some of the most common types of incontinence include:

• Urinary Incontinence – urine leaks from the body unintentionally.
• Fecal Incontinence – uncontrolled leaking of fecal material from the anus.
• Stress Incontinence –  involuntary urine leaking that occurs during physical movement or activity
• Urge Incontinence – sudden urge to urinate
• Overflow Incontinence – small amounts of urine leak out continuously.
• Functional Incontinence –  inability to control the passing of urine or feces.
• Total Incontinence –  bladder cannot store any urine at all

Other Treatment Options:

An incontinence pad is used for light cases of incontinence.  For those cases that are moderate or sever, more protections is needed.  An alternative for more severe cases is the use of an adult diaper.  A diaper is made from similar materials as an incontinence pad, but has a higher rate of absorbency which is better suited for larger leaks.

There are also several devices available to woman that can be implanted to prevent urine leaks.  The two types of devices are listed below

•  Urethral insert → a small tampon-like device that is inserted into the urethra before physical activity.  This device absorbs any leakage that may occur to prevent incontinence.  The device can be removed by the user and disposed.
• Pessary  → a stiff ring that is inserted into the vagina.  The pessary will hold up the bladder, which will prevent any urine leaks.  As seen in Figure 2 below, pessaries come in many different shapes and sizes to achieve the appropriate level of lifting the bladder.

Figure 2: Types of Pessaries

Instead of the use of a biotextile device, some interventional therapies can be used to prevent the occurrence of an incontinence.  Below is a list of some common therapies.

• Bulking Material Injections → A synthetic material is injected into the tissue surrounding the urethra.  The material “bulks” which closes the urethra and prevents urine leakage.
• Botulinum toxin type A (Botox) → An injection of Botox is made into the muscle of the bladder.  This type of therapy works with people who have an overactive bladder.
• Nerve Stimulators → Painless electrical pulses are delivered to sacral nerves (nerves involved in bladder control) from a small device that is implanted under the skin.  The device is implanted under the skin in your buttock and connected to wires on the lower back

If no other devices help to prevent incontinence, an alternative treatment can be the use of a catheter.  A catheter is a soft tube that is inserted into the urethra to drain the liquid in the bladder.  This process is done several times a day.

Application of an Incontinence Pad:

An incontinence pad is a non-invasive biotextile.  This textile product is designed for every day use and can be applied by the user.  The incontinence pad does not need to be applied under sterile conditions.  It can be used by anyone who experience a urine incontinence and has a light case.

Contra-Indications: the incontinence pad can cause skin irritations, uncomfort due to bulky or creasing of product, and pressure sores.

The process to apply an incontinence pad is quite simple, an adhesive strip is located on the back of the pad.  The adhesive covering is removed to expose the adhesive and is secured to the undergarment.  Below is a video that explains how to apply an incontinence pad and also mentions other types of incontinence products.

 

Advantages and Deficiencies of Incontinence Pads (including Reusable vs. Disposable): 

Advantages	Deficiencies
Disposable pads promote hygiene and sanitation	Only good for small amounts of liquid, can’t handle much more than that on the pad
Allows people to go about their daily lives without worrying about social stigma	Disposable pads produce a lot of waste, therefor not very sustainable
Can be used for a wide variety of patients with various medical histories	Cannot be flushed down toilets
Disposable pads are convenient and easy to carry around	Reusable pads require more care

Product Studies:

One area of study the product has been evaluated under is performance. The analysis had examined the relationship between pad properties such as; absorption, strike-through, wetback, and comfort of wearing while wet. 

Two experiments were performed for this study, on three different types of pads. The first experiment performed in this study was a single-blind test type. The test was done with 20 women that have light urinary incontinence, who were given the three unlabeled pad types. The three pad types each had the same design geometry, each with a different combination of materials. The pads used by the testers were collected, and saved to weigh them. The experimental group of wearers were asked to report and record the wet comfort of each pad. They were then scored for their performance, absorbency, and wet comfort. 

In the second experiment, the testers used the same three pad types again, each for a week. They were collected at the end of the week and compared to the pad that was used the week before. The absorption, wetback, and strike through properties for each type of pad was measured in a lab. The wet comfort was measured by the recording of the participants.

The study results showed that as the wet comfort was improved, absorption capacity was highly increased. It was also found that design specs of each of the pads may have hid the major differences between the pads. [2]

The second study focuses on the impact of incontinence pad moisture condition, on the skin in contact with it. When tissues with underlying bone structures are exposed to mechanical loading and moisture for an extended period of time, pressure ulcers can surface. This study was conducted to investigate this common problem caused by moist incontinence pads that many pad wearers experience. “The skin tolerance to mechanical loading will be affected by the local microclimate, with changes in temperature and humidity directly influencing both the local structures and tissue homeostasis.”

 Twelve participants with no underlying health problems were selected to evaluate one incontinence pad design. The pad was evaluated in three different conditions: 0%, 50%, and 100% liquid capacity. Trans-epidermal water loss (the passage of water across the skin’s surface,) along with inflammatory biomarkers were sampled from the affected area.

The results showed no distinct change in trans-epidermal water loss in the 0% liquid pad. When the pad did increase in moisture, there was a large increase in  trans-epidermal water loss. Loaded moist pads caused a large increase in biomarkers as well. The study overall showed compromising effects to the epidermal skin layer when the skin was exposed to the moist incontinence pads for an endured period of time. However, these changes were reversed during off-loading. The incontinence pads had provided some protection while dry. [8]

FDA Reservations:

There are no true reservations from the FDA within the regulations for incontinence pads. Incontinence pads are listed as ‘protective garments for incontinence’. The FDA identifies further identifies an incontinence pad as “a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient’s garment from the patient’s excreta.” If the incontinence pad does not include fragrance or any excess chemicals, the product is able to continue manufacturing and distribution. The product is also “exempt from good manufacturing practice requirements of a good quality system but are required to meet general standards of protection.” [3]

Product Market:

Figure 3: Global disposable incontinence products market.

• Marketing 

  • The market is increasing due to an understanding of lifestyle of people of all ages
  • Not just for elderly, but for people of all ages that are using incontinence pads to improve their lifestyle
  • Technological advancements are improving the way these products are viewed
    • less bulky, more discrete
  • To learn more: Incontinence Product Market [4]

• Evaluation 

  • A thriving market
  • Disposable incontinence product market to cross $15 billion by 2025 [4]
  • Beginning a shift towards reusable products

• Distribution

  • Easily accessible to the general public
  • Found in many supermarkets 
  • No need for a prescription or any sort of medical procedures
  • Found in hospitals and other medical centers, readily available for patients 

References:

[1] Bainbridge, L. (2019, July 15). Adult Incontinence: A Comprehensive Guide. Retrieved from https://www.beaucare.com/blog/adult-incontinence-comprehensive-guide/

[2] Bostan, L. E., Worsley, P. R., Abbas, S., & Bader, D. L. (2019). The influence of incontinence pads moisture at the loaded skin interface. Journal of Tissue Viability, 28(3), 125–132. doi: 10.1016/j.jtv.2019.05.002https://www-sciencedirect-com.prox.lib.ncsu.edu/science/article/pii/S0965206X1830161X

[3] “CFR – Code of Federal Regulations Title 21.” Accessdata.fda.gov, 1 Apr. 2019, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=876.5920.

[4] Global Market Insights Inc. (2019, July 08). Disposable Incontinence Products Market to Cross $15 Billion by 2025: Global Market Insights Inc. Retrieved May 01, 2020, from https://www.prnewswire.com/news-releases/disposable-incontinence-products-market-to-cross-15-billion-by-2025-global-market-insights-inc-300880562.html

[5] Incontinence Pads: Product Guide, Comparisons, and Insurance Coverage: HCD. (2020, January 23). Retrieved May 01, 2020, from https://www.hcd.com/incontinence/comparing-incontinence-pads/

[6] Mayo Clinic. (2019, April 13). Urinary incontinence. Retrieved from https://www.mayoclinic.org/diseases-conditions/urinary-incontinence/diagnosis-treatment/drc-20352814

[7] Moderator. (2019, March 28). How Do Incontinence Pads Work? Retrieved May 01, 2020, from https://www.incontinence.co.uk/how-do-incontinence-pads-work

[8] Thornburn, P. (1997). Wound Ostomy and Continence Nurses Society. Journal of Wound, Ostomy and Continence Nursing, 24(4), 219–225. doi: 10.1097/00152192-20060100000017https://journals.lww.com/jwocnonline/Abstract/1997/07000/Improving_the_Performance_of_Small_Incontinence.9.aspx

[9] Uniquewellness. (2019, July 16). Adult Diaper and Other Ways to Manage Incontinence. Retrieved from https://wellnessbriefs.com/blog/2018/01/17/adult-diapers-ways-manage-incontinence/?_vsrefdom=googleads&gclid=CjwKCAjw4KD0BRBUEiwA7MFNTXV9EZkEUQq1PqgaX_HrH6bR8_0L3fYAXccQNBCYWhtz0-1KRgd_WxoC8MUQAvD_BwE

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