Identification of Key Odorants in Used Disposable Absorbent Incontinence Products.

PURPOSE: The purpose of this study was to identify key odorants in used disposable absorbent incontinence products. DESIGN: Descriptive in vitro study SUBJECTS AND SETTING:: Samples of used incontinence products were collected from 8 residents with urinary incontinence living in geriatric nursing homes in the Gothenburg area of Sweden. Products were chosen from a larger set of products that had previously been characterized by descriptive odor analysis. METHODS: Pieces of the used incontinence products were cut from the wet area, placed in glass bottles, and kept frozen until dynamic headspace sampling of volatile compounds was completed. Gas chromatography-olfactometry was used to identify which compounds contributed most to the odors in the samples. Compounds were identified by gas chromatography-mass spectrometry. RESULTS: Twenty-eight volatiles were found to be key odorants in the used incontinence products. Twenty-six were successfully identified. They belonged to the following classes of chemical compounds: aldehydes (6); amines (1); aromatics (3); isothiocyanates (1); heterocyclics (2); ketones (6); sulfur compounds (6); and terpenes (1). CONCLUSION: Nine of the 28 key odorants were considered to be of particular importance to the odor of the used incontinence products: 3-methylbutanal, trimethylamine, cresol, guaiacol, 4,5-dimethylthiazole-S-oxide, diacetyl, dimethyl trisulfide, 5-methylthio-4-penten-2-ol, and an unidentified compound.

What differentiates symptomatic from asymptomatic women with lichen sclerosus?

AIMS: To investigate the differences between symptomatic and asymptomatic women with vulvar lichen sclerosus (LS). METHODS: Data on file concerning 228 LS patients was retrospectively reviewed. RESULTS: Most patients were symptomatic (193/228; 85%). Worsening of symptoms related to specific food intake was experienced by 26% (48/182) and pork was the most frequently cited (25/48; 52%); worsening at night was reported by 47% (87/185). Being over 50 years at the time of diagnosis or being menopausal were associated with being symptomatic (RR = 2.47, 95% CI: 1.15-5.29 and 6.55, 2.05-20.91, respectively). The same was true for urinary incontinence (UI) (5.23, 1.78-15.42), the use of absorbents (without UI) (3.59, 1.05-12.34) and dyspareunia (5.28, 1.64-17.0). All patients with a family history of LS were symptomatic. There was no association with hormonal factors or specific vulvar anatomical changes. CONCLUSIONS: Pork consumption may be involved in the worsening of symptoms. UI and the use of absorbents are more commonly present in symptomatic LS patients. Dietary changes and correction of UI might be useful in the control of LS symptoms. © 2015 S. Karger AG, Basel.

A systematic review of the effect of daily panty liner use on the vulvovaginal environment.

BACKGROUND: Whether panty liners predispose to vulvovaginitis is unclear. OBJECTIVES: To clarify the effects of the use of panty liners on the female genital tract. SEARCH STRATEGY: Several electronic databases (including PubMed and Embase) were searched to identify studies published in English before May 3, 2012. SELECTION CRITERIA: Case-control studies, randomized controlled trials, and cohort studies comparing young women who did and did not use panty liners in the intermenstrual period were included. DATA COLLECTION AND ANALYSIS: The quality of the studies was assessed using the Newcastle-Ottawa Scale or the Jadad Scale. Data from suitable studies were extracted for analysis. MAIN RESULTS: Five articles met the inclusion criteria. Four studies-all of which included only healthy women-found no significant clinical implications arising from the use of panty liners. The fifth study was of women with recurrent candidiasis and showed that use of panty liners was associated with new candidiasis episodes. CONCLUSIONS: The intermenstrual use of panty liners does not seem to have a negative effect on the vulvovaginal area.

An investigator blinded cross-over study to characterize the cutaneous effects and suitability of modern sanitary pads for menstrual protection for women residing in the USA.

BACKGROUND: The cutaneous and sensory effects of the practical usage of sanitary pads have been studied globally. However, clinical studies in the United States were conducted only quite a long time ago, and the results of these studies were not published. METHODS: Fifty-four women residing in the United States were asked to use commercially available sanitary pads with a nonwoven unique surface sheet and pads with a perforated film. This was a cross-over study design conducted over the course of two menstrual periods. A board certified dermatologist evaluated the levels of erythema and fissuring, burning, stinging and itching sensations based on clinical observations and interviews. Measurement of pH and swabs for bacteria counting of vulvar skin were also performed. Data from the first clinical evaluation conducted prior to the first menstrual cycle were used as the baseline. At the end of the study, the subjects were asked to complete self-assessment questionnaires about product suitability. RESULTS: Forty-two women (age: 18-50, mean: 37.5) completed the study. No signs of irritation or meaningful differences from the baseline were found in the clinical observations or in the interviews by the dermatologist for either product. No significant difference from baseline was found in the vulvar skin surface pH or in the number of total bacteria for either product. The results of the suitability indicated that the majority of subjects were highly satisfied with both types, but they especially preferred the sanitary pad with a nonwoven unique surface top sheet. CONCLUSION: These results revalidate the results of a previous clinical study in the United States and are consistent with recent reports of worldwide clinical trials of high performance sanitary pads.

Cutaneous and sensory effects of two types of sanitary pads with different surfaces in the Shanghai, Chinese population.

BACKGROUND: Regional differences in practices, ethnicity, and climate may influence the skin compatibility of sanitary pads. Although several clinical trials have been performed in North America, Mexico, Western Europe, Eastern Europe, and Africa, there is no clinical study reported for Asia. OBJECTIVE: The purpose of this study was to examine the skin compatibility of two types of modern sanitary pads in Chinese women along with a dermatological assessment and their satisfaction and preference. MATERIALS AND METHODS: The self-feeling and safety of a new sanitary pad with a non-woven top specially-shaped surface sheet was tested and compared with a conventional sanitary pad with a perforated film top sheet. The subjects studied were 22 Chinese women (age: 20-50 years) with a history of mild and occasional sanitary pad dermatitis residing in Shanghai. One subject wished to discontinue the trial for personal reasons, thus 21 subjects completed the trial. These subjects were randomly assigned to two types of sanitary pads, and used one type during their next menstrual period, and another type during their following menstrual period. After each menstrual period, a dermatologist examined the objective and subjective skin symptoms and determined a score. The subjects were asked to rate their level of satisfaction with respect to overall usability, softness, stickiness, dryness, and absorbency, and to choose which pad they had preferred. RESULTS: No adverse effect was observed for either type of pad. Edema, erythema, burning, and stinging were not obvious symptoms for either type of pad. For itching, 30-65% of the subjects scored slight or mild for both types of pads. A comprehensive evaluation showed that several symptoms were observed on both type of pads at slight and mild levels, but minimal and insignificant differences were found between them. The majority of subjects were highly satisfied with both types, but preferred the new sanitary pad with a non-woven specially-shaped surface top sheet for its softness and absorbency. CONCLUSION: Our results indicate that both types of sanitary pads were tolerated well by Chinese women, thereby providing an important extension of earlier studies.

Dermatological testing of an emollient-treated menstrual pad with a novel foam absorbent core.

Dermatological testing was used to assess the skin compatibility of a menstrual pad with an emollient-treated surface layer and a novel, polymeric absorbent foam core. The test program included: 1) skin patch tests to assess cumulative skin irritation, 2) human repeat insult patch tests to assess the potential for contact sensitization, and 3) repeated application to the popliteal fossa ("behind-the-knee" test) to assess combined chemical irritation and frictional effects. Studies showed the new product and its components to be as mild to skin as other commercially available materials with no evidence for the induction of delayed contact hypersensitivity. Pads with an emollient-based topsheet finish were milder to the skin than pads with a conventional topsheet finish. The test program provides reassurance that the skin compatibility of the new menstrual pad is similar to that of conventional marketed pads with a history of safe use and consumer acceptance.

Skin interaction with absorbent hygiene products.

Skin problems due to the use of absorbent hygiene products, such as diapers, incontinence pads, and feminine sanitary articles, are mostly due to climate or chafing discomfort. If these conditions are allowed to prevail, these may develop into an irritant contact dermatitis and eventually superficial skin infections. Skin humidity and aging skin are among the most significant predisposing and aggravating factors for dermatitis development. Improved product design features are believed to explain the decline in observed diaper dermatitis among infants. Where adult incontinence-related skin problems are concerned, it is very important to apply a holistic perspective to understand the influences due to the individual's incontinence level and skin condition, as well as the hygiene and skin care measures provided. Individuals with frail, sensitive skin or with skin diseases may preferably have to use high-quality products, equipped with superabsorbent polymers and water vapor-permeable back sheets, to minimize the risk of skin complications.

Influence of usage practices, ethnicity and climate on the skin compatibility of sanitary pads.

Modern disposable sanitary pads are becoming available worldwide. Regional differences in usage practices, ethnicity, and climate may influence their skin compatibility. Pad usage practices depend on culture, economics, and menstrual physiology. Daily usage is higher in Japan and but lower in Nigeria compared to North America or Western Europe. Evidence for ethnic differences in skin irritant susceptibility is not compelling. Dark skin may be less susceptible to certain irritants than fair skin; the Japanese may experience a higher degree of sensory irritation than Caucasians. Ambient conditions such as high temperature and humidity increase the skin temperature and skin surface moisture under sanitary pads by small but measurable amounts, causing no discernible skin irritation; vapor-permeable pad backings reduce these effects. Cold dry conditions, which can irritate exposed skin, may not affect vulvar skin to the same degree due to its elevated hydration and occlusion. To address the practical significance of these variables, results of prospective clinical trials of sanitary pads performed by industry and academic scientists in North America (Indiana), Mexico, Western Europe (Munich, Athens, Goteborg, Sweden), Eastern Europe (Kiev) and Africa (Abuja, Nigeria) were reviewed. Despite the diverse range of conditions, no significant adverse skin effects were observed with modern pads compared to traditional pad designs. Study participants generally preferred modern pads for performance and comfort.

Do panty liners promote vulvovaginal candidiasis or urinary tract infections? A review of the scientific evidence.

Panty liners are used to absorb light menstrual flow, vaginal discharge, or urine leakage, or to maintain a clean, dry feeling. Allegations that panty liners may trap heat and moisture to promote vulvovaginal candidiasis (VVC) or promote colonization by microbes that contribute to urinary tract infections appear to be unfounded. As reviewed herein, measurements of the impact of panty liners on skin temperature and skin surface moisture had no clinically meaningful effect on cell densities of genital microflora. Epidemiological investigations of a potential link to VVC were either negative or were inconclusive because of confounding factors. Although enteric microbes reside on the vulva and perineum, no evidence exists that panty liner use promotes urethral colonization by enteric microbes. Moreover, a series of 13 randomized prospective trials of panty liners or ultra-thin pads demonstrated no clinically significant adverse effects either on the skin or on isolation frequencies or cell densities of representative genital microflora. Post-market surveillance systems suggest a low incidence of complaints. Evidence from vulvar clinic patients reveals no significant contribution of these products to persistent vulvar symptoms. Taken together, the scientific evidence supports the conclusion that panty liners are safe when used as intended and do not promote VVC or urinary tract infections.

A multi-centre evaluation of absorbent products for men with light urinary incontinence.

AIMS: This study compared the performance of the four main designs of absorbents for men with light incontinence: pouches (shields), leafs (guards), washable pant with integral pad (pantegral), and small disposable pad. MATERIALS AND METHODS: We did a multiple crossover trial. Men with light urinary incontinence were recruited. All pouches and leafs available in the UK were identified for inclusion. A single pantegral and small pad were selected based on previous evaluations for design comparison. Products were tested in random order for up to 1 week. Performance criteria (e.g., leakage and comfort) were rated using a validated product performance questionnaire. Wet product weights and amount of leakage were recorded in pad leakage diaries. "Overall opinion" for design performance was used as the primary outcome indicator. RESULTS: Seventy-four men tested six leafs, six pouches, one pantegral, and one small pad. Leakage data was taken from 3,386 wet pads. The pouches generally performed poorly with few significant differences between products. The leafs were more variable with large and significant differences in ratings. Overall the leaf, pantegral, and small pad designs performed significantly better than the pouch (P

The Behind-the-Knee test: an efficient model for evaluating mechanical and chemical irritation.

BACKGROUND/PURPOSE: The 'Behind-the-Knee' method (BTK test), using the popliteal fossa as a test site, evaluates both the inherent chemical irritation, and the potential for mechanical irritation of substrates and products. This approach eliminates some of the difficulties of in-use clinical test systems while still providing reliable results. In this publication, examples of the results of BTK tests on several materials are presented with direct comparisons, where possible, with results of in-use clinical testing conducted on the same materials. METHODS: In in-use clinical tests, volunteer panelists were provided with catamenial products to use in place of their normal product. In the BTK test, samples were applied daily to the popliteal fossa using an elastic athletic band. In both studies, irritation reactions were scored visually. RESULTS: Levels of irritation in the BTK test are consistently higher than those of standard patch tests, illustrating the contribution of mechanical irritation to the overall irritant potential of materials and products. Repeated tests on identical test materials demonstrated that the BTK test results are reproducible. Side-by-side comparisons of the BTK test and in-use clinical tests demonstrated that the BTK test produces results of similar quality to the in-use clinical. By using several concurrent panels with a common test material, it is possible to compare the irritant properties of several materials at once. CONCLUSIONS: We have tested over 25 different materials in over 35 BTK studies. The test method has proven reliable and versatile in testing a wide variety of materials, including menstrual pads, topsheets, interlabial pads, pantiliners, tampons and lotion coatings on products. Unlike in-use clinicals, the BTK test allows the direct comparison of two products at one time on the same individual, and is easily adapted to investigative programs. It is subject to fewer confounding factors, is much easier to implement, has a shorter turnaround time, and is less expensive than in-use clinical testing. Importantly, unlike standard patch tests, the BTK test evaluates both the inherent chemical irritation associated with materials and the mechanical irritation owing to friction. Although the BTK test was developed using catamenial products, the test system provides a valuable alternative for evaluating any material where mechanical irritation may play a role, including textiles, facial tissues, baby and adult diapers, and laundry products that may leave residues on fabrics.

Evaluation of modifications of the traditional patch test in assessing the chemical irritation potential of feminine hygiene products.

BACKGROUND/AIMS: The first main objective of the work presented in this paper was to investigate ways of optimizing the current arm patch test protocol by (1) increasing the sensitivity of the test in order to evaluate more effectively the products that are inherently non-irritating, and/or (2) reducing the costs of these types of studies by shortening the protocol. The second main objective was to use the results of these studies and the results of the parallel studies conducted using the behind-the-knee method to better understand the contribution of mechanical irritation to the skin effects produced by these types of products. In addition, we were interested in continuing the evaluation of sensory effects and their relationship to objective measures of irritation. METHODS: Test materials were prepared from three, currently marketed feminine protection pads. Wet and dry samples were applied to the upper arm using the standard 24-h patch test. Applications were repeated daily for 4 consecutive days. The test sites were scored for irritation prior to the first patch application, and 30-60 min after removal of each patch. Some test sites were treated by tape stripping the skin prior to the initial patch application. In addition, in one experiment, panelists were asked to keep a daily diary describing any sensory skin effects they noticed at each test site. RESULTS: All protocol variations ([intact skin/dry samples], [compromised skin/dry samples], [intact skin/wet samples], and [compromised skin/wet samples]) gave similar results for the products tested. When compared to the behind-the-knee test method, the standard upper arm patch test gave consistently lower levels of irritation when the test sites were scored shortly after patch removal, even though the sample application was longer (24 vs. 6 h) in the standard patch test. The higher level of irritation in the behind-the-knee method was likely due to mechanical irritation. The sensory skin effects did not appear to be related to a particular test product or a particular protocol variation. However, the mean irritation scores at those sites where a sensory effect was reported were higher than the mean irritation scores at those sites were no sensory effects were reported. CONCLUSIONS: All four protocol variations of the standard upper arm patch test can be used to assess the inherent chemical irritant properties of feminine protection products. For these products, which are inherently non-irritating, tape stripping and/or applying wet samples does not increase the sensitivity of the patch test method. Differences in irritation potential were apparent after one to three 24-h applications. Therefore, the standard patch test protocol can be shortened to three applications without compromising our ability to detect differences in the chemical irritation produced by the test materials. The patch test can be used to evaluate effectively the inherent chemical irritation potential of these types of products. However, this method is not suitable for testing the mechanical irritation due to friction that occurs during product use. There is no relationship between specific test conditions, i.e., compromised skin and/or testing wet samples and reports of perceived sensory reactions. However, there seems to be a clear relationship between sensory reactions and objective irritation scores.

Development of a sensitive test method to evaluate mechanical irritation potential on mucosal skin.

BACKGROUND/PURPOSE: The studies presented here are intended to continue the validation of the behind-the-knee test system developed to evaluate the mechanical irritation potential of products such as catemenial pads, baby and adult diapers (which are inherently non-irritating products/chemicals). These products are intended to be worn for prolonged periods of time on body sites that include the mucous membrane and non-keratinized epithelium in addition to normal squamous cell epithelium. These studies had two specific goals. The first was to validate the test model using a variety of conditions, including those that mimic the conditions that exist during normal product use. The second specific goal was to determine the most cost-effective protocol to use for screening different product executions for potential irritant effects. If the model proves to be reliable under a variety of conditions, it will be an ideal test system to use in claims support studies, where it is preferable to mimic use conditions as closely as possible. We were also interested in evaluating sensory responses that consumers often associate with irritation to determine if any of these sensations correlated with objective measures of irritation. METHODS: Three test materials were used in these experiments. All three are commercially available catemenial pads that were expected to be similar, but not identical, in irritant properties based on subjective consumer reports of irritation associated with product use. Test materials were applied daily to the area behind the knee and held in place for 6 h by an elastic knee band of appropriate size. Irritation was graded 30-60 min after test product removal, and the following morning before application of the next sample. Two products were compared using four different protocol variations: dry product on intact skin, dry product on tape stripped (compromised) skin, wet product (i.e., product loaded with 8 mL of saline) on intact skin and wet product on compromised skin. An additional study compared the two products using two protocol variations (intact skin/dry product vs. compromised skin/wet product). In addition, a study (#5) was conducted to compare a third product applied wet on intact vs. compromised skin. In the final two studies, information was collected from the panelists on subjective sensations of irritation. RESULTS: All four protocol variations were capable of detecting significant differences between the products. These differences were directionally similar to what was expected based on subjective consumer comments. In addition, a higher number of certain perceived sensory effects were reported for the more irritating product. CONCLUSIONS: In these studies, Product A is more irritating than Product B when assessed objectively, i.e., by scoring irritation at the test sites, and subjectively, i.e., by evaluating reports of adverse sensations perceived by panelists. There is no clear relationship between specific test conditions, i.e., compromised skin and/or testing wet samples, and reports of perceived sensory reactions. However, some sensory reactions appear to be associated with higher levels of irritation. The most cost-effective protocol to use for screening for potential irritant effects for catemenial pads, baby and adult diapers is two 6-h sample applications on intact skin, with scoring in the afternoon 30 min after removal of the sample. For claims support testing, a variety of test conditions can be used in the behind-the-knee assay to mimic the exposure conditions for the product under evaluation, including using compromised (tape stripped) skin and wet product samples.