This is the protocol for a review and there is no abstract. The objectives are as follows:
The objective of the review is to determine the effectiveness of toileting assistance programmes for managing urinary incontinence in adults.
Urinary incontinence often presents as an acute or chronic physiological condition. It may also occur as a direct consequence of the inability to reach and use the toilet or bathroom independently, or to access toileting assistance in a timely manner. Without timely assistance to use the toilet, many care-dependent individuals with functional or cognitive impairments will be incontinent. However, there is a need to identify the best methods to implement and sustain toileting assistance programmes, especially when caring for cognitively impaired care-dependent individuals who may be unable to communicate their need for assistance, and when caring takes place in an organisation such as a long-term aged care facility. The question of whether toileting assistance programmes are effective and, if so, for which group of individuals and under what set of circumstances are relevant to formal carers working in long-term aged care facilities, and for informal carers caring for a person in their own home.
Description of the condition
Toileting assistance programmes target incontinence that may occur as a consequence of the inability to reach and use the toilet or bathroom because of functional or cognitive impairment. Cognitive deficits may interfere with the ability to perform the self-care activities related to maintaining continence, and functional impairments such as poor mobility or limited hand dexterity may interfere with the ability to physically reach and use the toilet. In order to maintain continence, many individuals with cognitive and physical impairments rely on timely assistance from a carer. Research involving frail older adults consistently reveals an association between incontinence and functional impairment (Brandeis 1997; Chiang 2000; Cigolle 2007; Huang 2007; Kutner 1994; Miles 2001; Nelson 2005; Ouslander 1987a; Ouslander 1987b; Ouslander 1993; Tinetti 1995; Wyman 1993) and between incontinence and cognitive impairment (Aggazzotti 2000; Borrie 1992; Brandeis 1997; Huang 2007; Nelson 2001; Ouslander 1987a; Ouslander 1987b; Rait 2005; Wetle 1995). Although the exact nature of these associations is unclear, toileting assistance programmes may benefit individuals who are functionally or cognitively impaired and who rely on a carer to assist them to maintain continence or to manage incontinence.
Caring for an adult with functional or cognitive impairments and addressing their need for continence care is a major cause of carer burden that can affect informal carers’ health, psychological well-being, and financial status (Brittain 2007; Cassells 2003; Gotoh 2009; Hayder 2008; Lane 2003; Langa 2002; Rigby, 2009; Upton 2005). It is also cited as a key reason why informal carers consider relinquishing the caregiving role and seek long-term formal care for the person for whom they care (Pearson 2002; Thomas 2004). Therefore, informal carers may need support to implement toileting assistance programmes that could promote a care-dependent individual’s ability to be continent and potentially minimise the overall burden of care.
Formal carers working in long-term aged care facilities for functionally or cognitively impaired frail older adults may also require support to implement toileting assistance programmes that could optimise residents’ abilities to be continent. However, these carers cite multiple barriers to promoting residents’ continence, such as the following.
Staff beliefs about incontinence and attitudes towards the elderly (Taunton 2005), and a lack of staff knowledge and education about incontinence (O'Connell 2005; Resnick 2006; Taunton 2005.
Staff shortages exacerbated by nursing staff absenteeism, frequent staff turnover and inconsistent staff assignments (Harke 1992; Lekan-Rutledge, 1998).
Staff workload demands and priorities (Funderberg Mather 2002; Lekan-Rutledge, 1998; Taunton 2005).
Inconsistent cooperation and communication between staff including a lack of teamwork (Funderberg Mather 2002), limited leadership and administrative support (Lekan-Rutledge, 1998) and poor communication about residents’ toileting schedules (Resnick 2006).
Staff members’ conflicting staff beliefs and goals, and difficulty or unwillingness to alter routines (Harke 1992).
Staff members’ lack of familiarity with the intervention (Lekan-Rutledge, 1998).
Resident characteristics (O'Connell 2005; Taunton 2005).
Insufficient educational resources, programmes and resources including a lack of appropriate documentation systems such as standardised tools, evidence-based practice guidelines and algorithms (O'Connell 2005).
Staff members’ limited access to continence services and experts (O'Connell 2005).
Family members’ expectations to use continence aids (Resnick 2006).
The organisation’s philosophy, time orientation, admission policies, employee career goals, organisational turbulence, interdisciplinary team interactions and decision-making processes (Salsbury-Lyons 2010).
In addition, formal carers are not always able to identify improvements in residents’ continence status as a result of a toileting assistance programme (Remsberg 1999). Such findings may explain why the use of toileting assistance programmes in long-term aged care facilities varies between countries. Sgadari, 1997 analysed 279,191 elderly residents’ assessments in long-term aged care facilities in Denmark, France, Iceland, Italy, Japan, Sweden and the USA and found that although over 95% of residents in facilities in Japan, Sweden and Iceland had a documented toileting assistance programme, 12.3% of residents in US facilities and 22.8% of residents in facilities in Italy did not. Based on observations of practice rather than documentation, Schnelle et al (Schnelle 1996; Schnelle 1991; Schnelle 1988a; Schnelle 1988b) found that residents in US facilities received toileting assistance an average of 0.37 times per resident per day. The same researchers reported discrepancies between care that was documented and the care that was actually delivered.
Thus, it appears that toileting assistance programmes are underutilised in practice in some long-term aged care facilities. It is therefore important to understand the relationship between programme effectiveness, the provision of staff or carer training and support, and the fidelity of intervention delivery. Hence, there is a need to systematically examine the effectiveness of toileting assistance programmes and identify the factors that predict or hinder effective uptake and outcomes.
Description of the intervention
Toileting assistance programmes represent one of many conservative interventions that aim to avoid or minimise episodes of incontinence by supporting carers so that they can use alternative strategies to manage a care-dependent individual’s urinary voiding activity. Unlike pelvic floor muscle training and bladder (re)training, toileting assistance programmes do not aim to change bladder function.
Toileting assistance programmes involve verbally prompting or physically assisting care-dependent individuals to go to the toilet at arbitrarily determined fixed voiding intervals or at times that are based on the individual's voiding pattern. It is likely that toileting assistance programmes will be enhanced when carers also use systematic contingent reinforcement strategies to modify the care-dependent individual’s behaviour. The efficacy of toileting assistance programmes may be enhanced by the addition of advice, education and ongoing support for carers. For example, in long-term aged care facilities, it may be necessary to additionally provide a structured education programme, ongoing clinical support, and supervisory feedback to optimise formal carers’ adherence to the intervention. Toileting assistance programmes are often implemented in conjunction with continence aids, medication, adjustments to fluid intake (including caffeine restriction), and exercise programmes to enhance care-dependent individuals’ mobility or toileting skills.
The literature describes two main approaches to implementing toileting assistance programmes.
The first approach relies on carers offering verbal prompts or physical assistance, or both, to the care-dependent individual to use the toilet at arbitrarily determined fixed voiding intervals, such as every two to four hours, regardless of whether they have an urge to void or not. A concern with this approach is that the care-dependent individual may develop iatrogenic urinary frequency, particularly if the intervoiding interval is enforced at frequent intervals such as every two hours (Palmer 2008).
The other approach involves identifying the care-dependent individual's usual voiding pattern and verbally prompting or physically assisting them, or both, to use the toilet prior to the predicted voiding time. Some individuals have predictable voiding patterns, which may relate to being in a stable environment where there are established times for meals, fluid take, medication, activities, rest and sleep, which can be identified by checking and documenting their continence status regularly over an extended period of time (that is up to 72 hours) or by using an electronic monitoring device (Colling 1992; Colling 1994).
In addition, carers may provide systematic contingent reinforcement strategies if they wish to additionally increase the individual’s attempts to identify their own continence status and request toileting assistance or self initiate toileting. Contingent reinforcement strategies involve systematically approaching the care-dependent person, enquiring if they require toileting assistance, asking them to identify their continence status, and providing positive or neutral feedback based on their response.
Regardless of which approach carers use, it may be necessary to alter the frequency of assistance to minimise or avoid incontinence.
The literature reveals various terms used to refer to toileting assistance programmes, including ‘prompted voiding’, ‘habit retraining’, ‘habit training’, ‘timed voiding’, ‘scheduled toileting’, ‘patterned urge-response toileting’ (PURT) and ‘individualised scheduled toileting’. A meta-study of the four Cochrane reviews on bladder training and toileting assisted programmes identified overlap between the definitions used to describe such programmes and their constituent components (Roe 2007a; Roe 2007b). Although each approach has a different theoretical basis, their use in practice may reveal similarities that warrant them being reconceptualised as ‘toileting assistance programs’ (Roe 2007a; Roe 2007b).
How the intervention might work
The overall goal of implementing a toileting assistance programme is to minimise or prevent incontinence rather than to restore bladder function. This is done by providing regular opportunities for the care-dependent person to void or by anticipating their need to void, or both. Prompted voiding additionally aims to change client behaviour by increasing self-initiated requests for toileting (Eustice 2000). Toileting assistance programmes differ from bladder retraining in that they do not rely on the person’s motivation or ability to learn and retain information. They do, however, rely on the availability and involvement of one or more caregivers.
Why it is important to do this review
Whilst providing individuals who are care-dependent and unable to reach and use the toilet with toilet assistance programmes independently ensures they have an opportunity to be continent, it is not yet clear how toileting assistance should be provided, particularly when individuals are cognitively impaired. This review will investigate the evidence for fixed interval toileting schedules, individualised toileting schedules, and the additional use of strategies such as contingent reinforcement and carer and staff education and support that aim to optimise their effectiveness.
Previous systematic reviews suggest that prompted voiding in frail older adults is promising, but its long-term effects and sustainability are questionable (Eustice 2000). Moreover, data about habit retraining and timed voiding are insufficient to provide empirical support for, or against, either intervention (Ostaszkiewicz 2004a; Ostaszkiewicz 2004b). As these approaches share the same aim, it would seem sensible to pool the available evidence and thereby strengthen the basis for future research and clinical practice. Moreover, by comparing the timing and duration or intensity of different toileting assistance approaches, a systematic review may establish the conditions and contexts under which they work.
This review is therefore an update and amalgamation of the three previous relevant Cochrane reviews (Eustice 2000; Ostaszkiewicz 2004a; Ostaszkiewicz 2004b).
The objective of the review is to determine the effectiveness of toileting assistance programmes for managing urinary incontinence in adults.
Criteria for considering studies for this review
Types of studies
Randomised or quasi-randomised trials of a toileting assistance programme for the management of urinary incontinence.
Types of participants
Adult men and women, with or without cognitive impairment, diagnosed as having urinary incontinence as defined by the trialists, either by symptom classification or by urodynamic study. They may be living in the community in their own home or nursing home, aged care home, residential care home, dual registered home, residential aged care facility, long-term care facility, skilled care facility, or veteran home.
Types of interventions
The following comparisons will be tested.
1. A toileting assistance programme versus usual care.
2. A toileting assistance programme plus another management option versus usual care.
3. A toileting assistance programme versus another management option.
4. A toileting assistance programme plus another management option versus a toileting assistance programme alone.
5. A toileting assistance programme plus another management option versus that option alone.
6. One form of toileting assistance programme versus another form of toileting assistance programme.
To be included in the review, the intervention must include the presence of a fixed or individualised voiding interval and the use of carers or staff to verbally prompt or physically assist the person to use the toilet. Because of the variety in toileting assistance programmes, the authors will describe the intervention components in the table 'Characteristics of included studies' and categorise interventions according to: (a) the addition of carer support or education, (b) the use of contingent reinforcement strategies, and (c) the programme duration.
Types of outcome measures
In this review, the following primary and secondary outcomes will be assessed.
A. Patient symptoms
Number of participants with no improvement in wet episodes (any, daytime, night-time)
Severity of incontinence (i.e. index score)
B. Quantification of symptoms
Mean proportion of hourly checks that participants are wet
Mean number of incontinent episodes over 24 hours (e.g. from bladder charts)
Mean pad changes in 24 hours (e.g. from completed bladder charts, total number and mean)
Volume of urine loss
Number of participant-initiated toileting episodes in 24 hours (e.g. from completed bladder charts)
Number of staff or caregivers adhering to the research protocol
D. Health status measures
Quality of life outcomes (e.g. Katz Index of Independence in Activities of Daily Living or the Short Form-36 Health Survey)
Participants’ or carers’ satisfaction and experience (e.g. EuroQol, I-QOL or Zarit Burden Inventory)
E. Adverse effects
Number of participants with skin problems
Urinary tract infection
Medication side effects
Iatrogenic urinary frequency
F. Health economic outcomes
Cost of pads, cost of providing toileting assistance, staff time to toilet, actual toileting time
D. Other outcomes
Non-prespecified outcomes judged important when performing the review
Search methods for identification of studies
We will not impose any language or other restrictions on any of the searches, which are described below.
The main source of trials will be the Specialised Register maintained by the Cochrane Incontinence Review Group, details of which are described under the Incontinence Group’s module in The Cochrane Library. The register contains trials identified from MEDLINE, MEDLINE in Process, CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL) and handsearching of journals and conference proceedings.
Searching other resources
We will utilise other sources: citation searching, contact with authors of reviews of behavioural interventions, and trialists of included studies. The reference lists of all relevant articles, including systematic reviews of behavioural interventions for the management of incontinence, will be searched.
Data collection and analysis
We will conduct data collection and analysis in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Selection of studies
Two review authors will independently screen all titles and abstracts. We will retrieve the full text of titles identified by either review author. Two review authors will also independently filter all full-text papers for inclusion. Disagreements will be discussed and, if necessary, referred to a third review author in the first instance or the Review Management Group and to the Cochrane Incontinence Group Editorial Team if unresolved.
Data extraction and management
Data will be independently abstracted and cross-checked by at least two review authors. Any disagreements will be resolved by discussion and if necessary by a third review author. Data relevant to the pre-stated outcome measures, characteristics of the study, interventions and participants will be extracted using a data extraction template. Included data will be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Where data may have been collected but not reported, further clarification will be sought from the trialists. Trial data will be grouped for analysis according to the comparison.
Assessment of risk of bias in included studies
All trials for consideration in the review will be independently assessed by two review authors. Any discrepancies will be resolved by discussion and, if necessary, by a third review author. The methodological quality of all included trials will be evaluated by two review authors using the criteria recommended by the Cochrane Incontinence Review Group and with reference to the Grading of Recommendations Assessment, Development and Evaluation (in short GRADE). In particular, trials will be assessed for randomisation procedure, adequacy of concealment and intention-to-treat analysis. Studies will not be excluded from the analysis on the basis of methodological quality, but they will be categorised as at low, unclear or high risk of bias as a basis for sensitivity analysis. However, if risk of bias is of concern, studies with high risk of bias may be excluded from the reported overall estimate of treatment effect.
Measures of treatment effect
We will use risk ratios (RR) for binary data (for example number of participants with incontinence); mean difference (MD) for continuous data (for example number of incontinence episodes) where the measure of the outcome is sufficiently consistent across trials; and the standardised mean difference otherwise. Generic inverse variance will be used for outcomes assessed using a mixture of dichotomous or categorical and continuous units of measurement.
Unit of analysis issues
Statistical advice will be sought regarding the use of data from cross-over trials and cluster randomised trials. Because of the potential carry-over effect from cross-over trials of toileting assistance programmes, data from cross-over trials will be used from the first arm only. Other data will be entered as 'Other data' only without applying statistical tests of significance or imputing data. Studies using a cluster randomised design will be assessed to determine the effects of clustering on the findings. Methods for calculating the risk of bias associated with clustering will be calculated with reference to Chapter 16 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Dealing with missing data
Where possible, we will use data based on explicit intention-to treat (ITT) analysis. If this is unclear, we will perform available case analysis, unless there is differential dropout from the groups. Dropout rates will be collected. Reasons for withdrawal and dropout that are reported by the trialists will be noted in the ’Characteristics of included studies’ table. Personal contact with authors will be attempted in order to obtain missing data.
Assessment of heterogeneity
Heterogeneity across studies will be assessed by visual inspection of plots of the data, the X 2 test for heterogeneity and the I2 statistic (Higgins 2011). Potential sources of heterogeneity will be explored.
Assessment of reporting biases
If there are 10 or more studies in the analysis, a funnel plot will be produced using methods recommended by the Incontinence Review Group.
Where appropriate, data will be quantitatively combined using meta-analysis to determine the typical effect of the intervention. We will use relative risk to summarise dichotomous outcomes; weighted mean difference to summarise trials that have used the same quantitative measure for example grams of urine, number of incontinent episodes; standardised mean difference for quantitative outcomes using different measurement units for example quality of life; and generic inverse variance for outcomes measured using both dichotomous or categorical and continuous measurement units for example subjective measures of improvement. We will apply the ITT principle as far as practicable (that is including all participants in the groups to which they were randomised, and not excluding any randomised participants). Trial data will be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) using the Cochrane Collaboration's statistical package RevMan 5. For individual clinical indicators, a fixed-effect model analysis will be applied as standard and pooled estimates of treatment effects with 95% confidence intervals; if heterogeneity is deemed a concern and a random-effects model analysis is performed, we shall additionally present the tau-squared (T2) statistic and an estimated range of underlying intervention effects (with 95% prediction interval).
Subgroup analysis and investigation of heterogeneity
The review authors will conduct subgroup analyses according to participants' location (that is community and long-term care facility) as well as by participants' cognitive and functional status.
If heterogeneity is judged to be a concern, we will explore the potential methodological and clinical reasons for this, primarily by performing sensitivity analyses and subgroup analyses. If it is still deemed appropriate to obtain an overall estimate of treatment effect, a random-effects model analysis may be used or results will be presented only for subgroups. If meta-analysis is not possible or is judged inappropriate (for example there is too much overall heterogeneity, even within subgroups or on excluding studies within a sensitivity analysis, or there are insufficient methodologically homogeneous studies to combine sensibly using a random effects analysis), narrative synthesis of treatment effects will be undertaken.
Subgroup analyses that we will consider include:
• duration on intervention;
• participants’ location (e.g. long-term care; or community setting);
• participants’ gender (male; female);
• participants’ cognitive status;
• participants’ functional status;
• type of incontinence (urge urinary incontinence (UI); stress UI; mixed UI; ‘functional’ UI; unclear);
• the severity of participants’ baseline incontinence (e.g. measured using the Incontinence Severity Index (Sandvik 1993)) (dry; slight; moderate; severe).
Appropriate sensitivity analyses will be performed to check the robustness of conclusions with any assumptions made in the inclusion of studies, or their analysis. This may include assessment based on study quality for example by excluding trials with high risk of bias or by excluding trials with high or unclear risk of bias.
We are grateful to all members of the Cochrane Incontinence Group in Aberdeen for their continual assistance with the review. The views expressed are those of the authors of the review.
Contributions of authors
All authors have contributed to developing the protocol and writing the review.
Declarations of interest
No declarations of interest.