Hospital materials managers foresee price hikes of 1%-10% for disposable adult diapers.
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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.
Absorbent Pads↗
Disposable diapers and infant skin.
In an experiment on skin rash caused by diapers, adult skin was used to compare the effects of disposable diapers (A; Pampers), conventional disposable diapers (B), and cotton diapers. Pieces of each type of diaper measuring 2 X 2 cm and containing 0.2 ml saline solution were pasted on forearm skin for 5 h. Water content of the corneum was measured with an impedance meter 1 h after the pieces were removed. Results were excellent for diapers A and B: there were no significant differences observed in water content of the corneum when A and B were compared with conventional cotton diapers. The advantages of disposable diapers were confirmed in infants.
Adult↗
Obscuring urinary incontinence. Diapering of the elderly.
To assess the prevalence, evaluation, and treatment of urinary incontinence in an institutionalized elderly population, the charts of 511 residents in a New York City nursing home were reviewed. Whereas the nurses' notes documented urinary incontinence in 62.4% of the total resident population, the physicians' notes listed this as a problem in only 10% of the residents. Most (90.3%) of the cases of incontinence were not classified as to etiology or pattern. Treatment emphasized the use of diapers in 78.2% of the cases, which was combined with bladder conditioning in most instances. This treatment approach had been initiated, administered, and monitored by the nursing staff. Indwelling catheters were used in 4.0% of the situations, and pharmacologic therapy was used in 2.5% of the cases. It is suggested that adult diapers may not be the optimal treatment for urinary incontinence since they treat the symptom instead of the cause. There should be a systematic approach to the classification and treatment of urinary incontinence prior to the long-term utilization of diapers.
Aged↗
Treatment of urge incontinence in Veterans Affairs medical centers.
Urinary incontinence has far-reaching medical, psychological, social, and economic effects. The objectives of this descriptive study were to examine utilization patterns and discontinuation rates of various pharmacologic agents used to treat symptoms of overactive bladder, primarily urge incontinence (UI), and to estimate the prevalence of urinary incontinence in the study population. Patient-level data regarding specific drugs used to treat UI and the use of diapers or pads over a 9-month period from October 1995 to May 1996 were retrospectively extracted from the medication databases of 9 Department of Veterans Affairs medical centers. A total of 2233 male patients were included in the analyses. Most patients were receiving oxybutynin chloride (39.8%), dicyclomine hydrochloride (16.0%), or imipramine hydrochloride (13.9%), and the remaining 30.3% were using flavoxate hydrochloride, propantheline bromide, hyoscyamine sulfate, and adult diapers or pads. Overall, 72.1% of patients had been prescribed daily dosages within the recommended dosing ranges for these medications. The majority (91.3%) of patients had not switched to another UI medication during the study period. Based on a chronic disease index, 47.6% of patients had 2 or fewer chronic diseases. Using pooled prevalence estimates, the estimated percentage of patients who had ever experienced UI in this population ranged from 7.4% to 20.8%; however, a considerably smaller percentage were taking medications for the treatment of UI. The results of this study suggest that oxybutynin, dicyclomine, and imipramine are the agents most commonly used to treat urinary incontinence within Veterans Affairs medical centers. The majority of patients who received a prescription for one of these drugs did not routinely refill the medication over the course of the study. There are many reasons for patients not to refill a prescription (eg, ineffectiveness, side effects, complications, obtaining the drug from another source), but the present study did not address the causes.
Adult↗
Analysis of costs borne by families of patients hospitalized for stroke.
BACKGROUND: Studies focusing on the economic impact of cancer on families have emphasized that costs of chronic disease are substantial for patients and their families. However, little effort has been devoted to measuring the costs of care for families of patients hospitalized with stroke. METHODS: A total of 215 stroke patients and their families from four teaching hospitals in the Taipei metropolitan area were monitored from the date of the patient's admission to hospital until the date of discharge. The value of labor contributed by families was estimated by assigning the current monetary market rate of providing health aide to the time families spent caring for patients in hospital. Lost earnings of patients and families, expenditure for medical care, and expenses for food, clothes, adult diapers, transportation and other miscellaneous items were determined and summed to arrive at the total family cost of providing care. RESULTS: The average cost of care for one family per inpatient day was NT$4,358.20. A total of 98.6% of the families incurred labor costs, which accounted for about half of family costs for providing care. Hospital bills accounted for almost 19% of total family costs. The income loss for families and patients accounted for about 25% of total family costs. Expenses for food, clothes, transportation, diapers and other illness-related miscellaneous items accounted for about 12% of total family costs. Multiple regression analyses demonstrated that the number of family members involved in giving care and the length of stay are important predictors for the total cost of care. Average total family costs per day increased by 24.3% when an additional family member was involved in providing care. Total family costs increased 2.5% for each hospital day. CONCLUSIONS: If direct and indirect nonmedical costs are not included in the total cost calculation for providing hospital care to stroke patients, the economic impact of care on families is likely to be underestimated.
Adult↗
Clozapine-induced urinary incontinence: incidence and treatment with ephedrine.
BACKGROUND: Treatment with the atypical antipsychotic drug clozapine appears to be associated with an increased incidence of urinary incontinence (UI). We posited that the potent anti-alpha-adrenergic effects of clozapine were involved, and hence that an alpha-adrenergic agonist would reduce UI. We tested this hypothesis by using ephedrine, an approved alpha-adrenergic agonist. METHOD: Fifty-seven inpatients with schizophrenia or schizoaffective disorder (DSM-IV) who met the Kane criteria for being treatment refractory were treated with clozapine (75-900 mg/day). Patients who developed UI were then openly treated with ephedrine in increasing doses until UI was attenuated or a dose of 150 mg/day was attained. RESULTS: Seventeen patients developed UI as evidenced by either urine-stained sheets/clothing or direct patient reports. In 2 cases, the UI was sufficiently severe that adult diapers had to be used. Comparison of patients who developed UI and those who did not showed that UI was associated with female gender and with concomitant treatment with typical antipsychotic drugs. One patient was treated with a behavioral program, but the remaining 16 patients were treated with ephedrine. Ephedrine treatment was very effective, with 15/16 patients showing improvement within 24 hours after reaching maximum ephedrine dosage. Twelve of 16 (including the 2 most severe) eventually had a complete remission of their UI. In the remaining 4 patients, 3 had a reduction in the frequency of UI and 1 showed no response. These benefits have been maintained over the course of 12 months of subsequent treatment for several patients. There were no side effects associated with the use of ephedrine nor were there any changes in neuropsychiatric status. CONCLUSION: Ephedrine appears to be a safe and effective treatment clozapine-associated UI. By inference, it is likely that clozapine may cause UI via its anti-alpha-adrenergic properties.
Adrenergic alpha-Agonists↗
Development of a new test for mechanical irritation: behind the knee as a test site.
BACKGROUND/AIMS: Certain consumer products, such as feminine hygiene products, and baby and adult diapers, are worn for prolonged periods of time in close proximity to the skin. A sensitive test method was needed to evaluate these products and their components for the potential to cause mechanical irritation during use. METHODS: We investigated several test sites on the body where normal, daily activities provided the opportunity for movement and, therefore, friction. These test sites were: the back of the knee, the axilla, and the wrist. Three exposure regimens were tested: 6-h daily for 4 days, 24-h daily for 3 days, and 24-h daily for 4 days. Controls consisted of satin fabric (a non-irritating material) or burlap (an irritating material). Test materials were secured to the test sites using an Ace elastic bandage (on the back of the knee), a snug fitting garment (on the axilla), or an athletic band (on the wrist). Test sites were scored for irritation on a visual scale prior to the initial application and 30-60 min after removal each day. Data were evaluated for the ability to reliably detect irritating materials, and for the ability to consistently differentiate between irritating and non-irritating materials. Quantitative measures of these abilities were used to rank the overall effectiveness of various test protocols as a model for mechanical irritation. RESULTS/CONCLUSION: The results of these studies indicated that a protocol using the back of the knee as a test site with an exposure regimen of 6-h daily for 4 days, best met the success criteria for an effective test system for evaluating mechanical irritation.
Adolescent↗
Treatment of Fecal Incontinence.
Fecal incontinence is a symptom of many disorders that can affect the nerves and muscles controlling defecation; it is not just due to exceptionally voluminous diarrhea. Underlying problems should be identified and treated, because that may improve incontinence. If treatment of the underlying problem does not correct incontinence, several approaches can be employed successfully. General approaches include stimulation of defecation at intervals to empty the rectum under supervised conditions; treatment of diarrhea, if present; addressing coexisting psychologic problems, such as depression; use of continence aids, such as adult diapers; and perineal skin care to prevent skin breakdown. Drug therapy includes use of constipating drugs, such as loperamide or diphenoxylate, that can impede the gastrocolic reflex, thereby limiting rectal filling and the likelihood of incontinence. Biofeedback training is useful in patients with some ability to sense rectal distention and to contract the external anal sphincter; instrumental learning using manometric or electromyographic biofeedback can be used to reinforce the rectoanal contractile response to rectal distention. Improvement in continence has been noted in up to 70% of suitable candidates with a single biofeedback training session. Patients with external anal sphincter disruption due to childbirth injury or other trauma may benefit from direct external anal sphincter repair (sphincteroplasty). In others, tightening up the anal canal by encirclement with nonabsorbable mesh (Thiersch procedure), perianal injection of fat, collagen, or synthetic gel, or radiofrequency electrical energy (Stretta procedure) may provide some palliation. Creation of a new sphincter mechanism by muscle transposition and encirclement of the anal canal is another approach that has been improved by use of electrical stimulators to keep the neosphincter contracted. Artificial anal sphincters patterned after artificial urinary sphincters have met with some success, but local infection remains problematic. When all else fails, fecal diversion (ileostomy, colostomy) can be effective in rehabilitating patients.
Journal Article↗
Are we reaching the limits or our ability to detect skin effects with our current testing and measuring methods for consumer products?
Testing for potential adverse skin effects is a key part of both the overall safety assessment for many consumer products and the evaluation of potential product improvements in mildness. Whilst modern tissue and paper products (i.e. facial tissues, catamenial products, baby wipes and baby and adult diapers) are inherently very mild to skin, current test methodology may not be robust enough to evaluate future improvements in such products. This article provides a commentary on several technologies we have been exploring to improve the sensitivity of test methods for tissue and paper products. The focus has been on three approaches: (i) further exaggerating exposure conditions using novel approaches to sample application, (ii) increasing the sensitivity of the manner in which we score for irritant effects, either visually or via instrumentation and (iii) quantitatively measuring additional endpoints, i.e. subjective sensory effects.
Consumer Product Safety↗
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.
Absorbent Pads↗
Arginine vasopressin levels in nursing home residents with nighttime urinary incontinence.
OBJECTIVES: To examine the relationship between diurnal urine volume and plasma arginine vasopressin levels (AVP) in nursing home residents with nighttime urinary incontinence and a comparison group of frail but nondemented, continent geriatric board and care residents. DESIGN: Case series. SETTING: Four nursing homes and two board and care facilities. PARTICIPANTS: Sixty-two nursing home residents and 27 board and care residents. MEASUREMENTS: Daytime (7:00 a.m. to 7:00 p.m.) and nighttime (7:00 p.m. to 7:00 a.m.) urine volumes of incontinent nursing home residents were measured over 3 days and 3 nights by reweighing preweighed adults diapers and toileting inserts emptied by research staff for the comparison group. AVP levels were drawn in the early morning (5:00 a.m. to 7:00 a.m.) before subjects arose and in the evening after an hour of lying in bed (8:00 p.m. to 11:00 p.m.), and plasma levels were determined by radioimmunoassay. RESULTS: Half of the nursing home residents and 82% of the comparison group had night/total urine volume ratios > or = 50%. Forty-nine percent of the total of 89 subjects had undetectable morning AVP levels, 61% had undetectable evening AVP levels, and 42% had undetectable AVP levels in both morning and evening. There were no significant differences in AVP levels between those with night/total urine volume ratios > or = 50% and < 50% in either the nursing home or comparison groups though the small number of comparison group subjects with ratios < 50% may have limited our statistical power to detect differences. CONCLUSION: Our data suggest that a substantial proportion of both nursing home residents with nighttime incontinence and frail geriatric patients with a reversal of the normal diurnal pattern of urine excretion have an accompanying deficiency in AVP production and/or secretion. More detailed physiologic studies are needed to understand better the pathophysiology of geriatric nocturia and nighttime incontinence and the role that AVP deficiency may play in these conditions. Until such studies are carried out, we do not recommend the routine use of exogenous AVP for geriatric patients with unexplained nocturnal polyuria.
Aged↗
Atrial natriuretic peptide levels in geriatric patients with nocturia and nursing home residents with nighttime incontinence.
OBJECTIVES: To determine if nocturnal polyuria in geriatric patients with nocturia and nocturnal incontinence is associated with elevated plasma atrial natriuretic peptide (ANP) levels. DESIGN: Case series. SETTING: Four nursing homes and two board and care facilities. PARTICIPANTS: Fifty-four nursing home residents and 26 board and care residents with a mean age of 86. MEASUREMENTS: Daytime (7:00 a.m. to 7:00 p.m.) and nighttime (7:00 p.m. to 7:00 a.m.) urine volumes of incontinent nursing home residents were measured over 3 days and 3 nights by reweighing preweighed adults diapers and toileting inserts emptied by research staff for the board and care group. Blood was drawn in the early morning (5:00 a.m. to 7:00 a.m.) before subjects arose and in the evening after an hour of lying in bed (8:00 p.m. to 11:00 p.m.), and plasma ANP levels were determined by radioimmunoassay. RESULTS: Forty-nine (61%) of the subjects had nocturnal polyuria as defined by night/total urine volume ratios > or = 50%. There was no significant difference between those with night/total ratios > or = 50% versus < 50% in plasma levels of ANP in the early morning (44.2+/-33.3, median 35.7 pg/mL vs 40.9+/-39.2, median 28.5; P = .36 by Mann Whitney U) or in the evening (43.4+/-28.8, median 36.4 pg/mL vs 49.6+/-53.1, median 34.4; P = .58). Nor was there any significant correlation between night/total urine volume ratio and morning or evening ANP levels (r = .01, P = .96 and r = .23, P = .31, respectively). CONCLUSIONS: In this sample of geriatric patients with nocturia and nursing home residents with nighttime urinary incontinence, ANP levels were elevated, but increased nighttime urine production was not associated with higher levels. Because of the variability in ANP levels, our power to detect such an association was low, and we cannot draw any definitive conclusions. Although high plasma ANP levels are unlikely to be a primary cause of nocturia and nighttime incontinence, they may, when combined with other factors such as low antidiuretic hormone levels, sleep disorders, and low functional bladder capacity, contribute to these symptoms in some geriatric patients.
Aged↗
Long-term ambulatory monitoring of urine leakage in the elderly: an evaluation of the validity and clinical applicability of thermistor signalling.
This study evaluated the validity and applicability of a low-cost Urine Leakage Recording Device (ULRD) in a geriatric setting. The ULRD consisted of a thermistor, connected to a portable, digital datalogger. The thermistor was positioned on a commercially available adult diaper. Five healthy females were instructed to void urine in seven behavioural conditions comprising general motor activity patterns of the average, psychogeriatric elderly in-patient. Voids were verbally indicated by the subjects and concomitantly recorded by the ULRD and the observer. After comparing the ULRD records--scored by three independent assessors--with the subjects' reports, on average (SD) 5.3 (0.6) of a total of 10 voids were classified correctly, whereas 9.3 (1.3) false positive events were indicated. None of the subjects reported any inconvenience as a result of the recording procedure. Although the ULRD is easily applicable, we conclude that it seems to be of little value in its present form as a method for long-term ambulatory monitoring of urine leakage.
Aged↗
[A questionnaire survey on urinary incontinence and urinary disturbances in the institutionalized elderly with senile dementia].
We carried out a questionnaire survey concerning urinary disturbances, among nursing home patients. The answers were obtained from 1,038 elderly including 355 males and 683 females. Ages, spanned 50-99, with an average age of 79.1. Of the 1,038 respondents which we obtained through our survey for management of urination, 35.8% of the total said that they are able to urinate without incontinence. Those able to urinate with incontinence accounted for 23.6% of the total. However, 40% of all patients required an adult diaper throughout the day to control their urinary functions. Patients suffering from neurological disorders accounted for 70% of respondents, and a correlation was seen between the extent of dementia and ADL, and excretory control. Urinary functioning in both men and women was found to grow increasingly difficult with age, and medical problems involving urinary difficulty appear to increase with the advance of the aging process. The representative groups for this survey were limited to elderly people in nursing homes, many of whom suffer from neurological disorders such as cerebral infarction. It was found that both male and female patients experience a variety of urinary disturbances.
Aged↗
Two cases of diaper area granuloma of the adult.
Two cases of diaper area granuloma are reported. Patient 1, a 34-year-old man, had multiple reddish-purple nodules over the diaper area of the right part of the genitocrural region. Candida albicans was not detected from the lesion. Histological examination of the nodule showed acanthosis and dense infiltrates. The granulomas became smaller and flatter after the control of urination. Patient 2, a 28-year-old man, had two large decubitus lesions and multiple nodules over the diaper area of the gluteal region. The decubitus became smaller and the granulomas disappeared after the lesion was kept clean. Because these granulomas resemble granuloma gluteale infantum, but occurred in adults rather than in the aged or infants, we propose to call this condition "granuloma gluteale adultorum." We suggest that these granulomas may represent an inflammatory reaction to the irritation of urine or feces. It is, therefore, of great importance to treat and prevent this condition by controlling the flow of urine and keeping the region clean.
Adult↗
[Single parenting in Germany. Conflict between job and diapers].
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Adult↗