A randomized, controlled trial comparing skin health effects and comfort of two adult incontinence protective underwear.

BACKGROUND/PURPOSE: It is important to confirm product use effects on skin health for products intended for prolonged skin contact. This study compared experimental and marketed reference adult incontinence protective underwear. METHODS: Randomized, single-blind (examiner), parallel study evaluating skin health effects in predominantly obese incontinent women normally using protective underwear (approximately 20% Type II Diabetes). Subjects wore experimental or marketed reference protective underwear daily, 14 consecutive days. Visual skin grading, transepidermal water loss (TEWL) assessed before, after 1 and 2 weeks of product wear. Overall assessment of comfort assessed. RESULTS: Of the 122 subjects (60 experimental and 62 marketed reference), 22 were diabetic and 88 were postmenopausal. Under the conditions of this study, there were no statistically significant differences in overall change from baseline for visual grading and TEWL between the experimental product and the marketed reference product for all subjects. Changes from baseline for skin erythema and skin marking were generally small for both products for all subjects as well as for both diabetics and non-diabetics. There were no serious adverse events (AEs), and no withdrawals due to AEs. Overall comfort assessments of size and fit were 'just right,' and skin comfort in the leg, waist and crotch areas were 'comfortable' or 'very comfortable' for both products. CONCLUSIONS: In-use 14-day testing demonstrated few statistical differences between experimental product with unique odor neutralizing technology and currently marketed product for skin assessments and comfort. Both products were comfortable and well-tolerated.

Testosterone treatment of HSDD in naturally menopausal women: the ADORE study.

OBJECTIVE: To evaluate the efficacy and safety of a transdermal testosterone patch (TTP, 300 microg/day) in naturally menopausal women with hypoactive sexual desire disorder (HSDD). METHODS: A total of 272 naturally menopausal women, predominantly not using hormone therapy, were randomized in this 6-month, placebo-controlled, double-blind, multicenter study to receive twice weekly either TTP or an identical placebo. Efficacy endpoints measured were the 4-week frequency of satisfying sexual episodes (SSE) using the Sexual Activity Log, the sexual desire domain of the Profile of Female Sexual Function and distress by the Personal Distress Scale. Safety was assessed by adverse events, laboratory parameters and hormone levels. RESULTS: The TTP group demonstrated significant improvements in SSE (p = 0.0089) as well as in sexual desire (p = 0.0007) and reduced personal distress (p = 0.0024) versus placebo at 6 months (intent-to-treat analysis, n = 247). The results were significant for all three endpoints in the subgroup (n = 199) not using hormone therapy. Similar numbers of women treated with placebo and TTP discontinued (n = 39, 27.5% vs. n = 26, 20%), reported adverse events (including application site reactions) (n = 101, 71.1% vs. n = 81, 62.3%) and withdrew due to adverse events (n = 20, 14.1% vs. n = 9, 6.9%). No clinically relevant changes were noted in laboratory parameters. Serum free and total testosterone levels increased from baseline in the TTP group (geometric means 5.65 pg/ml and 67.8 ng/dl, respectively, at week 24) within the physiological range; no changes were seen in estradiol and sex hormone binding globulin levels. CONCLUSIONS: TTP was effective in treating HSDD and improving sexual function in this study of naturally menopausal women with and without concurrent hormone therapy.

Prevalence of Alzheimer's disease and dementia in two communities: Nigerian Africans and African Americans.

OBJECTIVE: This article reports on a prevalence study of dementia and Alzheimer's disease among two groups of subjects with the same ethnic background but widely differing environments. METHOD: The study was conducted among residents aged 65 years and older in two communities: Yorubas (N = 2,494) living in Ibadan, Nigeria, and African Americans (N = 2,212 in the community and N = 106 in nursing homes) living in Indianapolis, Indiana. The study design consisted of a screening stage followed by a clinical assessment stage for selected subjects on the basis of their performance on the screening tests. RESULTS: The age-adjusted prevalence rates of dementia (2.29%) and Alzheimer's disease (1.41%) in the Ibadan sample were significantly lower than those in the Indianapolis sample, both in the community-dwelling subjects alone (4.82% and 3.69%, respectively) and in the combined nursing home and community samples (8.24% and 6.24%, respectively). The prevalence rates of dementia and Alzheimer's disease increased consistently with advancing age in both study groups. CONCLUSIONS: To the authors' knowledge, this is the first study, using the same research method at the two sites, to report significant differences in rates of dementia and Alzheimer's disease in two different communities with similar ethnic origins.

Comparing two prevalence rates in a two-phase design study.

An epidemiological study often uses a two-phase design to estimate the prevalence rate of a mental disease. In a two-phase design study, the first phase assesses a large sample with an inexpensive screening test, and then the second phase selects a subsample for a more expensive diagnostic evaluation. Furthermore, disease status may not be ascertained for all subjects who are selected for disease verification because some subjects are unable to be clinically assessed, while others may refuse. Since not all screened subjects are selected for diagnostic assessments, there is potential for verification bias. In this paper, we propose the maximum likelihood (ML) and bootstrap methods to correct for verification bias for estimating and comparing the prevalence rates under the missing-at-random (MAR) assumption for the verification mechanism. We also propose a method to test this MAR assumption. Finally, we apply our methods to a large-scale prevalence study of dementia disorders.