Predicting response to a community-based educational workshop on incontinence among community-dwelling older women: Post hoc analysis of the CACTUS-D trial.

AIMS: Our goal was to identify which women participating in an educational workshop on incontinence were most likely to benefit from it. METHODS: We included women aged 65 or older, living in the community, and not treated for incontinence despite reporting urinary leakage at least twice a week. The workshop's aims were to change beliefs about accepting incontinence as a normal part of ageing, explain that incontinence is not irreversible, and that solutions exist. We performed structured interviews at 6 and 12 months to assess impressions of improvement (PGI-I) and changes in both continence (ICIQ-FLUTS) and quality of life (I-QOL). RESULTS: The analysis included 392 women, 39% aged 80 or older and 57% with daily urinary incontinence. Twelve months after the workshop, 16% of women were "much better" (PGI-I); factors associated with impression of improvement were refusal to believe that incontinence is part of normal ageing at baseline and improvement of urinary symptoms. The median improvement was 4 points on the ICIQ-FLUTS and 8 on the I-QOL. Factors associated with a clinically significant improvement in urinary symptoms were more severe baseline urinary incontinence, obesity, and starting Kegel exercises. Factors associated with a clinically significant improvement in quality of life were a poor urinary quality of life at baseline and an age younger than 81 years. CONCLUSIONS: A short, inexpensive and nonmedical intervention can change the mind-set and behavior of older women with incontinence who are not seeking care. A clinically significant improvement is possible even in women with severe symptoms.

Long-term effect of community-based continence promotion on urinary symptoms, falls and healthy active life expectancy among older women: cluster randomised trial.

BACKGROUND: The long-term effectiveness of group continence promotion delivered via community organisations on female urinary incontinence, falls and healthy life expectancy remains unknown. METHODS: A pragmatic cluster randomised trial was conducted among 909 women aged 65-98 years with urinary incontinence, recruited from 377 community organisations in the UK, Canada and France. A total of 184 organisations were randomised to an in-person 60-min incontinence self-management workshop (461 participants), and 193 to a control healthy ageing workshop (448 participants). The primary outcome was self-reported incontinence improvement at 1-year. Falls and gains in health utility were secondary outcomes. RESULTS: A total 751 women, mean age 78.0, age range 65-98 completed the trial (83%). At 1-year, 15% of the intervention group versus 6.9% of controls reported significant improvements in urinary symptoms, (difference 8.1%, 95% confidence intervals (CI) 4.0-12.1%, intracluster correlation 0.04, number-needed-to-treat 13) and 35% versus 19% reported any improvement (risk difference 16.0%, 95% CI 10.4-21.5, number-needed-to-treat 6). The proportion of fallers decreased from 42% to 36% in the intervention group (-8.0%, 95% CI -14.8 - -1.0) and from 44% to 34% in the control group (-10.3%, 95% CI -17.4 - -3.6), no difference between groups. Both intervention and control groups experienced a gain in health utility (0.022 points (95% CI 0.005-0.04) versus 0.035 (95% CI 0.017-0.052), respectively), with no significant difference between groups. CONCLUSION: Community-based group continence promotion achieves long-term benefits on older women's urinary symptoms, without improvement in falls or healthy life expectancy compared with participation in a healthy ageing workshop.

Protocol for the IDEAL-2 longitudinal study: following the experiences of people with dementia and their primary carers to understand what contributes to living well with dementia and enhances active life.

BACKGROUND: There is a major need for longitudinal research examining the experiences of people with dementia and their primary carers, as relatively little is known about how the factors associated with capability to 'live well' vary over time. The main aim of the IDEAL-2 study is to investigate how and why, over time, people with dementia and their primary carers might vary in their capability to live well with dementia, whilst exploring both their use of health and care services and their unmet needs. METHODS: IDEAL-2 will build on the Improving the experience of Dementia and Enhancing Active Life (IDEAL) cohort of 1547 people (who, at recruitment between July 2014 and July 2016, had mild-to-moderate dementia), and their 1283 primary carers in Great Britain. The existing cohort will be enriched with additional participants with mild-to-moderate dementia (and their primary carers where available and willing) from the following groups: people with rarer forms of dementia, and/or those who are ≥90 years or < 65 years of age at time of recruitment. We will assess the primary outcome, capability to live well with dementia, and the factors influencing it using questionnaires at yearly intervals for 3 years. Additionally, we will seek to link the cohort data with administrative data to obtain information about health service use. Some participants will be invited for in-depth face-to-face interviews. The cohort study will be supplemented by linked research focusing on: the co-production of new measures of living well; including the perspectives of people with advanced dementia living in residential care settings; including people with dementia from black, Asian, and minority ethnic groups; and understanding the experience of people living with undiagnosed dementia. DISCUSSION: IDEAL-2 will provide evidence about the key indicators of, and factors associated with, living well over the course of dementia and how these differ for particular subgroups. It will tell us which combinations of services and support are most beneficial and cost-effective. Moreover, the IDEAL-2 study will gather evidence from under-researched groups of people with dementia, who are likely to have their own distinct perceptions of living well.

Clinical Evaluation of a Prototype Underwear Designed to Detect Urine Leakage From Continence Pads.

PURPOSE: We evaluated the performance of prototype underwear designed to detect urine leakage from continence pads, their acceptability to users, and their effect on health-related quality of life and psychosocial factors. DESIGN: Prototype product evaluation. SUBJECTS AND SETTING: Participants were 81 women with an average age of 67 years (range, 32-98 years) recruited between October 2010 and February 2012 from outpatient clinics, general practice surgeries, community continence services, and through charities and networks. METHODS: The TACT3 project developed and manufactured a prototype undergarment designed to alert the wearer to a pad leak before it reaches outer clothing or furniture. The study was conducted in 2 stages: a pilot/feasibility study to assess general performance and a larger study to measure performance, acceptability to users, health-related quality of life, and psychosocial impact. Participants were asked to wear the prototype underwear for a period of 2 weeks, keeping a daily diary of leakage events for the first 7 days. They also completed validated instruments measuring lower urinary tract symptoms, health-related quality of life, and psychosocial impact. RESULTS: On average, 86% of the time participants were alerted to pad leakage events. More than 90% thought the prototype underwear was "good" or "OK" and that it would or could give them more confidence. Mean scores for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form indicated no change in the level of symptoms reported before or after the intervention, and no significant changes in health-related quality of life status occurred, except improvement in for travel restrictions. Evaluation via the Psychosocial Impact of Assistive Devices Scale also indicated a positive impact. CONCLUSION: The prototype underwear evaluated in this study was effective and acceptable for 5 out of every 10 wearers. Findings also suggest that the prototype underwear is suitable for women of all ages, dress sizes, and continence severity.

Efficiency of using community organisations as catalysts for recruitment to continence promotion trials.

BACKGROUND: A major challenge for determining the effectiveness of community-based continence promotion campaigns is recruitment of a representative sample of incontinent participants who have not previously sought care. PURPOSE: To evaluate the efficiency of engaging community organisations as catalysts for recruitment of community-dwelling older women with incontinence to the 'Continence across Continents' randomised controlled trial. METHODS: Seniors' and women's community-based organisations throughout the United Kingdom were solicited by telephone or email to assist recruitment for an open-label cluster randomised controlled trial testing three experimental continence promotion interventions and a control intervention for incontinent older women. Women aged 60 years and older who experienced at least weekly urinary incontinence and who had never sought treatment were eligible to participate. The response rate of the organisations and enrolment rate of eligible participants attending the continence promotion workshops were recorded. Differences in recruitment efficiency by intervention group were ascertained using analysis of variance statistics. RESULTS: We contacted 408 community organisations over a 1-year period. Seventy organisations (17%) agreed to host a workshop, 249 (61%) did not provide a response, and 89 (22%) refused. Workshops were administered in a group format to 61 organisations (15%); 667 women attended, 583 (87%) submitted the screening questionnaire, and 437 (66%) met eligibility criteria for inclusion. A total of 192 women consented to participate in the trial, yielding a 44% recruitment efficiency among workshop attendees known to be eligible, with no significant difference in enrolment rates between groups. However, the mean participant recruitment rate per number of attendees at each workshop was only 29%, varying substantially between groups from 19% to 37%, with the lowest rate observed for the control group. The mean annual recruitment rate expressed as the number of enrolled participants per community organisation contacted was 0.5. LIMITATIONS: Reasons for women's non-response were not collected. The findings may be country specific. CONCLUSIONS: The recruitment rate for a continence promotion trial among older women known to be eligible and attending workshops hosted by local community organisations was high (44%). Strategies are needed to bolster community organisations' involvement in health promotion trials in general and for continence issues in particular.

Urinary incontinence: a vibration alert system for detecting pad overflow.

A sensor and electronics system is described that monitors the leakage of urine from continence pads into surrounding underwear. Urinary incontinence is involuntary loss of urine and occurs when the bladder muscles contract without warning or the sphincter muscles surrounding the urethra are too weak to prevent leakage. The system comprises a wetness sensor and electronics unit. The sensor is stitched into the underwear and detects overspills of urine from the pad. The electronics unit is attached to the underwear and responds by vibrating, signaling to the wearer that pad has failed. This system has application for individuals who use continence pads in the community, but it could also be used in care homes.

Assessing the stigma content of urinary incontinence intervention outcome measures.

The goal of this narrative review is to evaluate the efficacy of available questionnaires for assessing the outcomes of "continence difficulty" interventions and to assess the selected questionnaires concerning aspects of stigmatization. The literature was searched for research related to urinary incontinence, as well as questionnaires and rating scale outcome measurement tools. The following sources were searched: Cochrane Library, EMBASE, Medline, and PubMed. The following keywords were used separately or in combination: "Urinary incontinence," "therapy," "treatment outcome," "patient satisfaction," "quality of life," "systematic reviews," "aged 65+ years," and "questionnaire." The search yielded 194 references, of which 11 questionnaires fit the inclusion criteria; 6 of the 11 questionnaires did not have any stigma content and the content regarding stigma that was identified in the other five was very limited. A representative model of how stigma impacts continence difficulty interventions was proposed. While the 11 incontinence specific measurement tools that were assessed were well researched and designed specifically to measure the outcomes of incontinence interventions, they have not been used consistently or extensively and none of the measures thoroughly assess stigma. Further studies are required to examine how the stigma associated with continence difficulty impacts upon health care interventions.

Female urinals for women with impaired mobility.

Margaret Macaulay and colleagues describe the range of female urinals currently available, provide guidance on product selection and introduce a novel device designed to overcome some of the limitations of conventional urinals.

Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial.

BACKGROUND: Urinary incontinence occurs in 40 % of women aged 65 years and over; however, only 15 % seek care and many delay healthcare seeking for years. Incontinence is associated with depression, social isolation, reduced quality of life, falls and other comorbidities. It is accompanied by an enormous cost to the individual and society. Despite the substantial implications of urinary incontinence on social, psychological and physical well-being of older women, the impact of continence promotion on urinary symptom improvement and subsequent effects on falls, quality of life, stigma, social participation and the cost of care remains unknown. METHODS: This study is a mixed methods multi-national open-label 2-arm parallel cluster randomized controlled trial aiming to recruit 1000 community-dwelling incontinent women aged 65 years and older across Quebec, Western Canada, France and United Kingdom. Participants will be recruited through community organizations. Data will be collected at 6 time points: baseline and 1 week, 3 months, 6 months, 9 months and 12 months after baseline. One of the primary objectives is to evaluate whether the continence promotion intervention improves incontinence symptoms (measured with the Patient Global Impression of Improvement questionnaire, PGI-I) at 12 months post intervention compared to the control group. Other co-primary outcomes include changes in incontinence-related stigma, fall reduction, and incremental cost-effectiveness ratio and quality-adjusted life years. Data analysis will account for correlation of outcomes (clustering) within community organizations. A qualitative sub-study will explore stigma reduction. DISCUSSION: Community-based continence promotion programs may be a cost-effective strategy to reduce urinary incontinence, stigma and falls among older women with untreated incontinence, and simultaneously improve quality of life and healthy active life expectancy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01858493 , registered 13 May 2013.

Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial.

OBJECTIVES: The primary objective of this cluster randomised controlled trial was to compare the effectiveness of the three experimental continence promotion interventions against a control intervention on urinary symptom improvement in older women with untreated incontinence recruited from community organisations. A second objective was to determine whether changes in incontinence-related knowledge and new uptake of risk-modifying behaviours explain these improvements. SETTING: 71 community organisations across the UK. PARTICIPANTS: 259 women aged 60 years and older with untreated incontinence entered the trial; 88% completed the 3-month follow-up. INTERVENTIONS: The three active interventions consisted of a single 60 min group workshop on (1) continence education (20 clusters, 64 women); (2) evidence-based self-management (17 clusters, 70 women); or (3) combined continence education and self-management (17 clusters, 61 women). The control intervention was a single 60 min educational group workshop on memory loss, polypharmacy and osteoporosis (17 clusters, 64 women). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was self-reported improvement in incontinence 3 months postintervention at the level of the individual. The secondary outcome was change in the International Consultation on Incontinence Questionnaire (ICIQ) from baseline to 3-month follow-up. Changes in incontinence-related knowledge and behaviours were also assessed. RESULTS: The highest rate of urinary symptom improvement occurred in the combined intervention group (66% vs 11% of the control group, prevalence difference 55%, 95% CI 43% to 67%, intracluster correlation 0). 30% versus 6% of participants reported significant improvement respectively (prevalence difference 23%, 95% CI 10% to 36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve any improvement in incontinence symptoms, and 5 to attain significant improvement. Compared to controls, participants in the combined intervention reported an adjusted mean 2.05 point (95% CI 0.87 to 3.24) greater improvement on the ICIQ from baseline to 3-month follow-up. Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of improvement in all intervention arms. CONCLUSIONS: Continence education combined with evidence-based self-management improves symptoms of incontinence among untreated older women. Community organisations represent an untapped vector for delivering effective continence promotion interventions. TRIAL REGISTRATION: ClinicalTrials.gov ID number NCT01239836.

A noninvasive continence management system: development and evaluation of a novel toileting device for women.

PURPOSE: This paper describes a project to develop and clinically evaluate a novel toileting device for women called the Non-Invasive Continence Management System (NICMS). The NICMS device is designed to provide an alternative toileting facility that overcomes problems some women experience when using conventional female urinals. DESIGN: A single product evaluation was completed; participants used the same device with 1 or 2 interface variants. SUBJECTS AND SETTING: Eighty women from 6 countries who were either mobile or wheelchair dependent evaluated the product over a 15-month period. RESULTS: The device was found to be useful in some circumstances for women and their caregivers. CONCLUSION: Significant further development is required for it to work reliably and to provide an acceptable device in terms of reliability, size, weight, noise, and aesthetics.