Absorbent products for urinary/faecal incontinence: a comparative evaluation of key product designs. A randomized controlled trial of the NEAT expandable tip continence device. Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition. Comparison of disposable diapers with fluff absorbent and fluff plus absorbent polymers: effects on skin hydration, skin pH, and diaper dermatitis. Evaluations of diapers containing absorbent gelling material with conventional disposable diapers in newborn infants. Anal plug for faecal incontinence. Effects of breathable disposable diapers: reduced prevalence of Candida and common diaper dermatitis. Translating clinical research into practice: a randomized controlled trial of exercise and incontinence care with nursing home residents. The effects of patterned urge-response toileting (PURT) on urinary incontinence among nursing home residents.
To compare the performance and cost-effectiveness of the key absorbent product designs to provide a more solid basis for guiding selection and purchase. Also to carry out the first stage in the development of a quality of life (QoL) instrument for measuring the impact of absorbent product use on users' lives.
                Three clinical trials focused on the three biggest market sectors. Each trial had a similar crossover design in which each participant tested all products within their group in random order. SETTING, PARTICIPANTS AND INTERVENTIONS: In Trial 1, 85 women with light urinary incontinence living in the community tested three products from each of the four design categories available (total of 12 test products): disposable inserts (pads); menstrual pads; washable pants with integral pad; and washable inserts. In Trial 2a, 85 moderate/heavily incontinent adults (urinary or urinary/faecal) living in the community (49 men and 36 women) tested three (or two) products from each of the five design categories available (total of 14 test products): disposable inserts (with mesh pants); disposable diapers (nappies); disposable pull-ups (similar to toddlers' trainer pants); disposable T-shaped diapers (nappies with waist-band); and washable diapers. All products were provided in a daytime and a (mostly more absorbent) night-time variant. In these first two trials, the test products were selected on the basis of data from pilot studies. In Trial 2b, 100 moderate/heavily incontinent adults (urinary or urinary/faecal) living in 10 nursing homes (27 men and 73 women) evaluated one product from each of the four disposable design categories from Trial 2a. Products were selected on the basis of product performance in Trial 2a and, again, day time and night-time variants were provided. The first phase of developing a QoL tool for measuring the impact of using different pad designs was carried out by interviewing participants from Trials 1 and 2a.
                Product performance (e.g. comfort, discreetness) was characterised using a weekly validated questionnaire. A daily pad change and leakage diary was used to record severity of leakage, numbers of laundry items and pads. Skin health changes were recorded weekly. At a final interview preferences were ranked, acceptability of each design recorded, and overall opinion marked on a visual analogue scale (VAS) of 0-100 points. This VAS score was used to estimate cost-effectiveness. In addition, a timed pad changing exercise was conducted with 10 women from Trial 2b to determine any differences between product designs.
                Disposable inserts are currently the mainstay of management for lightly incontinent women (Trial 1) and they were better for leakage and other variables (but not discreetness) and better overall than the other three designs. However, some women preferred menstrual pads (6/85) or washable pants (13/85), both of which are cheaper to use. Washable inserts were worse both overall and for leakage than the other three designs (72/85 found them unacceptable). For disposable inserts and disposable diapers, findings from the community (Trial 2a) and nursing home trials (Trial 2b) were broadly similar. Leakage performance of disposable inserts was worse than that of the other designs for day and night. Pull-ups were preferred over inserts for the daytime. The new T-shaped diaper was not better overall than the traditional disposable one. However, there were important differences in performance and preference findings for men and women from both trials. Pull-ups (the most expensive) were better overall than the other designs for women during the day and for community-dwelling women during the night. Although disposable diapers were better for leakage than disposable inserts (the cheapest), women did not prefer them (except in nursing homes at night), but for men the diapers were better both overall and for leakage and were the most cost-effective design. No firm conclusions could be drawn about the performance of designs for faecal incontinence. Nursing home carers found pull-ups and inserts easier to apply (in the standing position) and quicker (in the pad change experiment) than the diaper designs; the ability to stand was associated with preference for pull-ups or inserts. The T-shaped diaper was not easier or quicker to change than the diaper. The washable products (Trial 2a) gave diverse results: they were better for leakage at night, but were worse overall for daytime than the other designs. Three-quarters of the women (27/36) found them unacceptable, but nearly two-thirds of men (31/49) found them highly acceptable at night. Findings from the two community trials (Trials 1 and 2a) showed that there were many practical problems in dealing with washable products but, together with the less effective and less expensive products, such as menstrual pads, they were more acceptable at home (and, in the case of washables, at night). This suggests that cost-effective management may involve combining products by using more effective (for a given user) but more expensive designs (e.g. pull-ups) when out and less effective but less expensive designs when at home. The interviews examining the impact of pad use on QoL provided themes and domains that can be further developed into a tool for further evaluation of absorbent products.
                This study showed that there were significant and substantial differences between the designs of absorbent products and for moderate/heavy incontinence some designs are better for men/women than others. There was considerable individual variability in preferences and cost-effective management may best be achieved by allowing users to choose combinations of designs for different circumstances within a budget. Further research is needed into the feasibility of providing choice and combinations of designs to users, as well as into the development of more effective washables and of specifically male disposable products. QoL measurement tools are needed for users of absorbent products, as are clinical trials of designs for community-dwelling carer-dependent men and women with moderate/heavy incontinence. Urethral devices are one conservative management option for stress and mixed urinary incontinence, but there is little published data about their use. The aims of this study were to assess the safety and efficacy of a new urethral device (NEAT) and compare it with the Reliance Insert. The ease of use of both devices was then evaluated. Twenty-four women with mixed or stress urinary incontinence, patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria, were enrolled in the study. Study subjects were blinded and randomly assigned to a device group. Device efficacy was assessed by pad weighing at 0 and 4 months. Success was defined as a 50% or greater reduction in urine loss using the formula 100[(pad weight without device -pad weight with device)/pad weight with device]. Safety was evaluated using urinalysis and urine cultures. Ease of use assessment scales were also completed. Eleven patients were randomized to the Reliance Insert and 13 to the NEAT device. There were no significant differences between the two groups in age, height, weight, duration of incontinence, pad weight, leakage score, parity or quality of life score. Based on the pad weight success formula, there was no significant difference in device success between the two groups at 4 months. Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight. Previous treatment, diagnosis and hormone replacement therapy all had no relationship to device success. Leakage score data showed that subjects had a significant decrease in urine leakage when using either device. There was no statistically significant difference in ease of use between the two devices. Adverse symptoms most commonly noted were awareness of the device (62.5%), urgency (29.2%), and urethral discomfort or pain (20.8%). One urinary tract infection (UTI) was observed. The most common finding on urinalysis was trace hematuria (15.8%). Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert. Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence. The risk of UTI is low, but these devices may cause trace hematuria. Disposable infant diapers with absorbent gelling material (cross-linked sodium polyacrylates) incorporated into the core were clinically evaluated for their effect on infant skin condition. Absorbent gelling materials tightly hold water and provide pH control by a buffering capacity as well as by helping to segregate urine apart from feces. Four clinical studies were conducted with each following a rigid protocol that controlled for variables of diet and age in addition to the diaper material that may influence the development of diaper dermatitis and helped to control for any inherent bias in the study. This allowed for the controlled assessment of skin condition with respect to diaper type. Absorbent gelling material-containing disposable, conventional (100% cellulose core) disposable, and home-laundered cloth diapers were test products. In these studies 1614 infants were initially enrolled with 522 of them assigned to absorbent gelling material disposable, 738 to conventional disposable, and 354 to home-laundered cloth diapers. Objective measurements of skin wetness (transepidermal water loss) and skin pH, as well as double-blind grading of diaper dermatitis, were the measures of skin condition. Absorbent gelling material disposable diapers were associated with significantly reduced skin wetness, closer to normal skin pH, and lower degrees of diaper dermatitis when compared to conventional disposable or home-laundered cloth diapers. The results are consistent with the hypothesis that better control in the diaper area of skin wetness, skin pH, and the prevention of the mixing of urine and feces produces a better diaper environment. Diaper dermatitis results from the action of a number of physical and chemical factors on the skin. While its etiology is complex, there is agreement that prolonged contact between wet diapers and the skin leading to excessive hydration of the stratum corneum and reduced barrier function is a primary factor. Recent research also indicates that pH elevation resulting from ammonia production increases the probability of skin damage due to fecal enzyme activity. New diapers containing absorbent polymers blended with cellulose fluff in the absorbent core have been developed. The absorbent polymer binds fluids and controls pH in the diaper environment. To assess the effectiveness of these diapers, a clinical study was conducted with approximately 150 infants over 15 weeks, using fluff diapers and absorbent polymer diapers. The results clearly showed that the diapers with absorbent polymer provide a better skin environment than those with fluff only with respect to lower skin wetness and pH control (instrumental measurements). In addition, the clinicians' grades indicated a directional reduction in diaper rash severity. We evaluated 149 infants diapered in either conventional cellulose core disposable diapers or diapers containing cellulose core with absorbent gelling material. The infants were evaluated from 1 day of age to 14 weeks of age for the prevalence and severity of diaper dermatitis. We identified a low prevalence of diaper dermatitis throughout the study period. At 14 weeks of age, we noted that infants in diapers containing absorbent gelling material had significantly less diaper dermatitis than those in conventional disposable diapers. Despite the overall low prevalence of diaper dermatitis in the newborn period, 7 of 204 infants evaluated had small skin erosions in the diaper area noted within the first 4 days of age. Both diaper types were associated with infants with erosions. This surprisingly high incidence of erosions in newborn infants suggests previously undocumented increased skin fragility of full-term infants. Despite the availability of pharmacological, behavioural and surgical treatments for faecal incontinence, many patients remain symptomatic. There are few devices designed specifically to cope with this, and perineal pads are inefficient and unacceptable for many patients. This study aimed to evaluate a new device in patients with intractable faecal incontinence.
                Two sizes of a purpose-designed anal plug were evaluated in 20 patients with intractable faecal incontinence for solid or liquid stool. Each plug size was tested for 2 weeks, with patients completing a structured questionnaire after each size.
                The majority [14/20] could not tolerate a plug due to discomfort. Four patients (20%) wished to continue to use a plug on a regular basis after the study, and two others on an occasional basis. However, for this minority who could tolerate a plug, it was highly successful at controlling faecal incontinence. There was no clear preference for the smaller or larger plug. There was no association between comfort in using the plug and anorectal sensitivity as measured by electrophysiological tests. It was not possible to predict which patients would benefit from plug use.
                The anal plug is effective in controlling faecal incontinence and is well tolerated in a minority of patients. Evaluation quickly reveals whether the patient will find it an effective and acceptable option. This device therefore offers a further management option for patients with faecal incontinence. Infants wearing breathable disposable diapers experienced significantly less diaper dermatitis (DD) compared to infants wearing standard, nonbreathable disposable diapers in a series of double-blind clinical trials. Severe DD, including confirmed infection with Candida albicans, was reduced by 38-50% among infants wearing highly breathable (HB) diapers. The prevalence of DD was inversely related to the breathability of the garments. The inhibitory effect of breathable diapers on the survival of Candida was further confirmed in controlled experiments with adult volunteers. A suspension of C. albicans cells was applied to delineated sites on the volar forearm. Each site was then covered by a full-thickness patch from either an HB or a standard diaper. Survival of Candida colonies was reduced by almost two-thirds in the breathable diaper-covered sites compared to the control sites. To examine clinical outcomes and describe the staffing requirements of an incontinence and exercise intervention.
                Randomized controlled trial with blinded assessments of outcomes at three points over 8 months.
                Four nursing homes.
                Two hundred fifty-six incontinent residents.
                Research staff provided the intervention, which integrated incontinence care and exercise every 2 hours from 8:00 a.m. to 4:00 p.m. 5 days a week.
                Average and maximum distance walked or wheeled, level of assistance required to stand, maximum pounds lifted by arms, fecal and urinary incontinence frequency, and time required to implement intervention.
                Intervention residents maintained or improved performance whereas the control group's performance declined on 14 of 15 outcome measures. Repeated measures analysis of variance group-by-time significance levels ranged from P <.0001 to.05. The mean time required to implement the intervention each time care was provided was 20.7 +/- 7.2 minutes. We estimate that a work assignment of approximately five residents to one aide would be necessary to provide this intervention.
                The incontinence care and exercise intervention resulted in significant improvement for most residents, and most who could be reliably interviewed expressed a preference for such care. Fundamental changes in the staffing of most nursing homes will be necessary to translate efficacious clinical interventions into everyday practice. To test an individualized form of habit training for urinary incontinence (UI) among long-stay cognitively and/or physically impaired elderly nursing home residents over time.
                Randomization of subjects occurred by nursing home unit. Baseline wet checks were done hourly for one 24-hour period at 3-week intervals over 12 weeks followed by 72 hours of continuous electronic monitoring to establish precise voiding patterns for each subject. The 12-week intervention period was administered by indigenous staff after they attended a 4-hour UI educational program. Subjects were followed an additional 12 weeks to determine the extent of maintenance of the intervention among staff and subjects.
                Four non-profit nursing homes; west, mid-west, east coast.
                Consent was obtained from 154 (71%) who met primary inclusion criteria. Forty-one failed the secondary inclusion criteria leaving 113 who entered the 37-week study. Eighty-eight completed the study (experimental = 51, control = 37); all were physically and/or mentally impaired, averaged age 85, and had either urge or urge/stress UI.
                UI was significantly decreased during the 3-month period (P less than 0.001). Eighty-six percent showed improvement over baseline while one-third improved 25% or more over their baseline UI rate. The control group's UI increased during the same period of time. The volume of UI among the experimental group also decreased (P less than 0.005) while the control group's UI volume increased.
                The training program was effective in reducing UI though compliance among nursing staff averaged only 70% of the prescribed toileting times. The success of this approach is similar to other recently described behavioral programs but achieved the reduction using only regular nursing staff. This individualized approach supports the recent regulatory thrust to individualize care to promote and maintain functional abilities and autonomy.
Although data were available from only two eligible trials the data were sufficiently robust to make some recommendations for practice. There is evidence that different designs are better for men and women. Diapers are the most cost-effective disposable design for men. Disposable pull-ups are most preferred for women but are expensive: disposable inserts are a cheaper alternative (except in nursing homes where diapers are preferred to inserts at night). Washable diapers are the cheapest design but have limited acceptability, confined mainly to some men at night. There were not enough people in the trials to draw any conclusions about which designs are best for faecal incontinence and no particular design seemed to be better or worse for skin health. People have different preferences for absorbent product designs and using a combination (different designs for day/night, going out/staying in) may be more effective and less expensive than using one design all the time.