Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of bladder training for treating adults with OAB; and summarise the principal findings of relevant economic evaluations of this intervention.
Background
For a glossary of terms used, see Appendix 1.
Description of the condition
Overactive bladder (OAB) is a common chronic condition associated with voiding dysfunction. The disorder reduces health‐related quality of life (HRQOL) and results in a significant economic burden on society (Irwin 2011; Vaughan 2011).
According to the International Continence Society (ICS), OAB is defined as "urinary urgency, usually accompanied by increased daytime frequency and/or nocturia, with urinary incontinence (OAB‐wet) or without (OAB‐dry), in the absence of urinary tract infection or other detectable disease" (Haylen 2010). OAB can be classified into two subtypes: OAB with urinary incontinence (OAB‐wet) and OAB without incontinence (OAB‐dry). The pathophysiological mechanisms contributing to OAB are categorised as neuropathic and non‐neuropathic mechanisms, although there is a lack of conclusive evidence in this regard. Neurogenic mechanisms operate through the following pathways: supraspinal (e.g. Parkinson's disease), spinal (e.g. spinal cord injury) and the peripheral nerve (e.g. diabetes mellitus) (Kennelly 2008). OAB that occurs in the absence of such neurogenic mechanisms is attributed to non‐neurogenic pathology and the contributory pathophysiological mechanisms remain unclear.
Depending on the definition of OAB used by studies, the estimated prevalence of OAB varies from 11.8% to 35.6% across studies (Coyne 2011; Irwin 2006; Milsom 2001; Stewart 2003). However, most observe that the prevalence of OAB increases with age. One study reported that the prevalence of OAB among people from Asia was lower than that in other races in both men and women (Coyne 2012), while another reported an increase in the global prevalence of OAB, particularly in low‐ and middle‐income countries within Africa, South America and Asia (Irwin 2011).
Because of the impact on quality of life, OAB is considered to be a major public health concern, with one study reporting that OAB might significantly diminish the HRQOL in patients (Vaughan 2011). In addition, OAB results in a notable economic burden on society. The EPIC study reported that the estimated total expenditure on OAB in six Western countries included in the study was EUR 9.7 billion in 2005 (Irwin 2009). As stated above, the prevalence of OAB is increasing in an ageing society and the economic burden is expected to become a more serious issue.
Description of the intervention
Treatment options for OAB include lifestyle interventions, behavioural therapy, pharmacotherapy, onabotulinumtoxinA administration, peripheral tibial nerve stimulation, sacral neuromodulation and surgery (Corcos 2017; Lightner 2019). The American Urology Association (AUA) guidelines recommend behavioural therapy as the first‐line treatment for OAB and pharmacotherapy as the second‐line treatment (Lightner 2019). Compared with antimuscarinics, behavioural therapy is associated with a lower risk of adverse events (Rai 2012). This is a significant advantage because OAB is a benign condition. Occasionally, a behavioural intervention and pharmacotherapy are used in combination to provide an additive effect.
Bladder training (sometimes called 'bladder drill', 'bladder retraining' or 'bladder re‐education') is a type of behavioural therapy that can help by minimising the frequent urge to urinate. There is currently no agreed or standardised definition but bladder training includes the following components (Fantl 1996):
Patient education: explaining the mechanism of bladder action and voiding function to enable patients to gain a better understanding of their excretory function.
Scheduled voiding: training to void at fixed voiding intervals while awake, which progressively lengthen as successful control is achieved.
Positive reinforcement: psychological support to patients to encourage them to continue the practice.
Despite the similarity in the basic framework, treatment protocols often differ, particularly with respect to where the intervention is delivered (such as outpatient, inpatient and home environments). Bladder training is usually provided directly by healthcare providers, although pamphlets, educational materials or information and communication technology (ICT) are occasionally used. It can be performed as either individual or group therapy. The duration of the therapy can vary but is usually recommended for 8 to 12 weeks (Lightner 2019).
How the intervention might work
Bladder training in people with OAB helps to control urgency by diverting their attention (e.g. performing mental arithmetic or pelvic floor muscle contractions) and helping them to relax (e.g. with deep breathing activities), and gradually prolonging the voiding interval by 15 minutes (Nygaard 2010). Eventually, the patient may be able to void every three to four hours without the frequent urge to urinate.
Although the exact processes remain unclear, it is thought that improving willpower contributes to the effectiveness of bladder training in people with OAB, particularly in terms of involuntary bladder contraction (Fantl 1981), afferent sensory impulses (Fantl 1991), and urethral closure during bladder filling (Fantl 1991). In addition, behavioural changes lead to an increase in the 'reserve physiologic capability' of urination function (Wyman 1998).
Bladder training is occasionally combined with other therapies, such as pelvic floor muscle training (PFMT) and pharmacotherapy, for an additive effect. In clinical practice, bladder training and PFMT are prescribed in combination and European Association of Urology (EAU) guidelines introduced both therapies as "behavioural and physical therapies" (Nambiar 2018). Pharmacotherapy, especially anticholinergics, is also combined with bladder training in clinical practice; AUA guidelines recommend the combination but the evidence is of low quality (Lightner 2019).
Why it is important to do this review
Although several systematic reviews have discussed bladder training for urinary incontinence (UI) and limited evidence has suggested its effectiveness (Roe 2007; Shamliyan 2008; Wallace 2004), few have assessed this intervention for OAB. Despite the clinical overlap, OAB does not necessarily accompany UI and the symptoms associated with both conditions can range in severity from mild (OAB) to moderate‐to‐severe (UI). It is therefore appropriate to investigate the effectiveness of bladder training in people presenting with OAB. As a secondary objective, this Cochrane Review will also summarise published evidence for the impact of bladder training on both resource use (costs) and its comparative efficiency (cost‐effectiveness).
Objectives
To assess the effects of bladder training for treating adults with OAB; and summarise the principal findings of relevant economic evaluations of this intervention.
Methods
Criteria for considering studies for this review
Types of studies
We will include randomised controlled trials (RCTs) assessing bladder training in adults with non‐neurogenic OAB. We will also include cross‐over RCTs and cluster‐RCTs. For randomised cross‐over trials, we will use data from the first period of treatment only. We will include studies that use the terms 'bladder drill', 'bladder retraining' or 'bladder re‐education'.
We will exclude quasi‐RCTs as their method of randomisation leaves these studies open to a high risk of selection bias.
Types of participants
We will include studies of all adult men and women (over 18 years old, or according to the study authors’ definition of 'adult') with non‐neurogenic OAB.
We will exclude studies of participants whose symptoms were caused by factors outside of the urinary tract (e.g. neurological disorders, cognitive impairment, gynaecological diseases). We will also exclude studies that recruited specific populations, such as people with nocturnal enuresis, people who have undergone urinary tract surgery or vaginal surgery, and antenatal or postnatal women.
Types of interventions
We will include studies with at least one study arm involving bladder training for treating OAB, as well as studies that investigate the additive effect with another treatment compared with monotherapy.
We will also include studies where the interventions are termed 'patient education', 'scheduled voiding' and 'positive reinforcement'.
As recommended in the AUA guidelines (Lightner 2019), behavioural therapy and pharmacological treatment are often prescribed in combination in clinical practice. However, the optimal treatment combination remains uncertain (Chancellor 2008). We will therefore include the following comparisons:
Bladder training versus no treatment.
Bladder training versus anticholinergics.
Bladder training versus β3‐adrenoceptor agonists.
Bladder training versus PFMT.
Bladder training combined with anticholinergics versus anticholinergics alone.
Bladder training combined with β3‐adrenoceptor agonists versus β3‐adrenoceptor agonists alone.
Bladder training combined with PFMT versus PFMT alone.
We believe that the comparisons of particular interest to patients and clinicians are 'bladder training versus no treatment', 'bladder training versus anticholinergics', 'bladder training versus β3‐adrenoceptor agonists' and 'bladder training versus PFMT'.
Types of outcome measures
Primary outcomes
Patient‐reported cure or improvement (assessed by validated self‐reported questionnaires such as the Patient Global Impression of Improvement (PGI‐I) Index (Busner 2007). In studies that do not use validated scales, we will include author‐defined data regarding the number of patients who perceive cure or improvement. For studies in which patients report more than a single level of improvement (e.g. much better and somewhat better), we will enter data for the greater degree of improvement reported).
Symptom‐ and condition‐related QoL (assessed using validated questionnaires, such as Overactive Bladder Questionnaire (Coyne 2002) and King’s Health Questionnaire (Kelleher 1997)).
Number of any adverse events (e.g. dry mouth, constipation, nausea, headache, dizziness, deceased visual acuity and urinary tract infection).
Secondary outcomes
Patient‐reported satisfaction.
Number of incontinence episodes per 24 hours.
Number of urgency episodes per 24 hours.
Number of micturition episodes per 24 hours.
Timing of outcome measurement
We will consider two time points for all primary and secondary outcomes: immediately after the treatment and at least two months after the treatment, to assess longer‐term effects. We will also seek data on adverse events during the treatment and at follow‐up. Ideally, longer‐term follow‐up will also be available.
Main outcomes for 'Summary of findings' tables
We will assess all primary and secondary outcomes for the 'Summary of findings' tables immediately after treatment, with the exception of adverse events, which will be assessed during treatment.
Search methods for identification of studies
We will not impose any restrictions, for example language or publication status, on the searches described below.
Electronic searches
Search for clinical effectiveness studies
We will identify relevant trials from the Cochrane Incontinence Specialised Register. For more details of the search methods used to build the Specialised Register, please see the Group's webpages where details of the Register's development (from inception) and the most recent searches performed to populate the Register can be found. To summarise, the Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In‐Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, NIHR Be Part of Research and handsearching of journals and conference proceedings. Many of the trials in the Cochrane Incontinence Specialised Register are also contained in CENTRAL.
The terms we will use to search the Cochrane Incontinence Specialised Register are in Appendix 2.
Search for economic evaluations
We will perform additional searches for the brief economic commentary (BEC). We will search:
The NHS Economic Evaluation Database (NHS EED) on the Centre for Reviews and Dissemination (CRD) website (covering from the earliest record in NHS EED, dating from 1968, up to and including 31 December 2014 when their coverage ended).
The NHS EED is no longer actively updated. Additional searches of the following databases will therefore be performed to identify eligible studies added to these databases from 1 January 2015 onwards:
MEDLINE on OvidSP (covering 1 January 1946 to the most recent available version).
Embase (on OvidSP) (covering 1 January 1974 to the most recent available version).
Details of the searches that will be performed can be found in Appendix 3.
Searching other resources
We will search the reference lists of relevant articles for potentially eligible studies.
Data collection and analysis
We will conduct data collection and analysis in accordance with methods specified in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019).
Selection of studies
Two review authors (SF and TY) will independently screen the list of titles and abstracts identified by our literature search and assess the eligibility of full‐text articles for inclusion in the review. Where necessary, we will contact study investigators for further information. We will resolve disagreements through discussion with a third review author (YL). We will also record the reasons for exclusion for excluded studies.
Data extraction and management
Two review authors (SF and YL) will independently extract data onto a pre‐piloted form, which will be cross‐checked by a third review author (AS). For trials with multiple publications, we will use only the most up‐to‐date data or complete data for each outcome. Where the necessary data are not reported or are not reported in a form that can be directly used for meta‐analysis, we will contact the trial authors for further information.
Assessment of risk of bias in included studies
At least two review authors (SF and YL) will independently assess the risk of bias of included studies using Cochrane's RoB 2.0 tool (Higgins 2019). The types of bias include the following: bias arising from randomisation process; bias due to deviations from the intended intervention; bias due to outcome data; bias in measurement of the outcome; bias in selection of the reported results; and overall bias.
We will assess the outcomes and timepoints included in the 'Summary of findings' tables, and will focus on the assessment of the effect of assignment to the interventions at baseline.
We will categorise each potential domain of bias as follows:
Low risk of bias: the study is considered to show a low risk of bias;
Some concerns: a few concerns are expected to be associated with the study in at least one domain but it does not warrant categorisation as a study with a high risk of bias with regard to any domain;
High risk of bias: the study is considered to be at high risk of bias in at least one domain; or a few concerns with regard to multiple domains are observed in the study such that these concerns significantly lower confidence in the study results.
We will summarise our findings in the ‘Risk of bias’ tables. We will express the percentage of agreement about the judgement of risk of bias and we will resolve any disagreements by consulting a third review author (TY).
Measures of treatment effect
For categorical data, we will use the ratio of the number of people who present with the outcome to the number of people at risk in each group to calculate a risk ratio (RR) with 95% confidence intervals (CI).
For continuous data, we will use means and standard deviations (SDs) to calculate a mean difference (MD) with 95% CI. When different scales are used, we will report standardised mean differences (SMD).
If data to calculate RRs or MDs are not reported, we will use the most appropriate numerical data available to calculate the actual numbers or means and SDs (e.g. test statistics and P values).
Unit of analysis issues
We will analyse trials that include multiple treatment groups by treating each pair of trial arms as a separate comparison. In such cases, we will divide the number of comparison groups dependent on the multiple intervention groups to avoid double counting. For randomised cross‐over trials, we will only use data from the first period of treatment. For cluster‐randomised trials, we will make corrections using an intracluster correlation coefficient (ICC). If this is not possible, we will calculate the ICC based on similar studies included in the review, or we will extract primary data and calculate RRs with 95% CIs. We will select ‘after treatment’ as a single time‐point and analyse data obtained only at this time.
Dealing with missing data
We will attempt to obtain missing data from the trial authors. Where this is not possible, we will analyse the trial data based on the intention‐to‐treat (ITT) approach. We will include summary statistics when approaches including mixed‐effects models for repeated measurements or multiple imputation methods have been used in the studies. If trials report sufficient details to calculate MDs or SMDs but not the associated SD, we will assume the outcome to show an SD equal to the highest SD from other trials within the same analysis.
Assessment of heterogeneity
We will assess heterogeneity between trials by visual inspection of plots of the data, the Chi² test for heterogeneity and the I² statistic. We will interpret the I² statistic using the thresholds in the Cochrane Handbook for Systematic Reviews of Interventions, with substantial heterogeneity defined as I² values between 50% and 90%, and considerable heterogeneity as I² values of more than 75% (Higgins 2019). We will aim to determine and discuss possible explanations for heterogeneity.
Assessment of reporting biases
We will assess potential publication bias using funnel plots and by performing an Egger's test when the meta‐analysis includes 10 studies or more (Egger 1997).
Data synthesis
The main analysis will include all studies that provide data regardless of the overall risk of bias as assessed by the 'Risk of Bias' 2.0 tool.
We will use Review Manager 2014 for data analysis. We will perform a meta‐analysis if patients, interventions, comparisons and outcomes are sufficiently similar. We will pool RRs using the Mantel‐Haenszel method for dichotomous outcomes and present MDs or SMDs using inverse variance for continuous outcomes. We will use a random‐effects model, except in cases of significant heterogeneity (I² > 50%) in which eventuality we will not perform a meta‐analysis. If we are unable to perform meta‐analyses, we will perform a narrative synthesis.
Subgroup analysis and investigation of heterogeneity
If data allows, we will perform the following subgroup analyses:
Heterogeneity among patients: sex and age (less than 65 years, more than or equal to 65 years);
Heterogeneity in treatments: intervention (face‐to‐face, pamphlets, ICT); types of sessions (individual versus group sessions); and duration of therapy (less than 12 weeks, more than or equal to 12 weeks).
Sensitivity analysis
If sufficient data are available, we will test the robustness of our results using the following sensitivity analyses.
Exclusion of cross‐over RCTs and cluster‐RCTs.
Exclusion of studies in which imputation of missing data is not performed
For outcomes included in the 'Summary of findings' tables, we will include data from studies judged at low risk of bias or with some concerns for that outcome. Data from studies judged to be at high risk of bias for that outcome will be excluded from the analysis. Risk of bias will be assessed by Cochrane's 'Risk of Bias' 2.0 tool as described above.
Incorporating economics evidence
Once the search outlined in the Search methods for identification of studies has been performed, we will develop a brief economic commentary (BEC) to summarise the availability and principal findings of the full economic evaluations that compare bladder training with alternative treatment interventions for OAB in adults (Shemilt 2019). This BEC will encompasses full economic evaluations (i.e. cost‐effectiveness analyses, cost‐utility analyses and cost‐benefit analyses), conducted alongside or based on one or more studies included in the main review of intervention effects, or model‐based economic evaluations.
Summary of findings and assessment of the certainty of the evidence
We will use the GRADE approach to assess the certainty of evidence related to the primary and secondary outcomes as listed in the Types of outcome measures (Schünemann 2019). We will use the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the certainty of the body of evidence for the pre‐specified outcomes. We will justify all decisions to downgrade the certainty of studies using footnotes.
We will prepare 'Summary of findings' tables using the GRADEpro software for the main comparisons prestated in Types of interventions if there is sufficient evidence (GRADEpro GDT).
Acknowledgements
We thank Joanne Booth, Dwayne Boyers, Sharon Eustice, Dr AG Radhika and Luke Vale for valuable comments on drafts of this protocol. In addition, we thank Sheila Wallace for her help with the literature search strategy, and Lindsey Elstub and Eugenie Johnson for their contributions to the editorial process.
We are grateful to Dr Osamu Ogawa for providing clinical expertise during the development of the protocol.
Appendices
Appendix 1. Glossary of terms
Neurogenic detrusor overactivity: detrusor muscle contractions occur during filling cystometry in the setting of a clinically relevant neurological disorder.
Nocturia: the number of times urine is passed during the main sleep period. Having woken to pass urine for the first time, each urination must be followed by sleep or the intention to sleep. This should be quantified using a bladder diary.
Overactive bladder (OAB): urinary urgency, usually accompanied by increased daytime frequency or nocturia, or both, with urinary incontinence (OAB‐wet) or without (OAB‐dry), in the absence of urinary tract infection or other detectable disease.
Appendix 2. Cochrane Incontinence Specialised Register search strategy
We will use the following search terms to search the Cochrane Incontinence Specialised Register:
((design.cct*) OR (design.rct*)) AND ((topic.urine.incon*) OR (topic.urine.overactive*)) AND ((intvent.psych.bladdrill*) OR (intvent.psych.behav*)) All searches will be of the keywords field of EndNote (EndNote 2018).
Appendix 3. Search methods for the brief economic commentary
We will perform additional searches for the brief economic commentary (BEC). We will search:
The NHS Economic Evaluation Database (NHS EED) on the Centre for Reviews and Dissemination (CRD) website (covering from the earliest record in NHS EED, dating from 1968, up to and including 31 December 2014 when their coverage ended).
The NHS EED is no longer actively updated. Additional searches of the following databases will therefore be performed to identify eligible studies added to these databases from 1 January 2015 onwards:
MEDLINE on OvidSP (covering 1 January 1946 to the most recent available version); and
Embase (on OvidSP) (covering 1 January 1974 to the most recent available version).
In order to find relevant papers added to these databases from 1 January 2015 onwards, we will use the filters developed by the CRD (to populate NHS EED) to search MEDLINE and Embase for economics studies added from 1 January 2015 onwards (CRD 2015). The NHS EED filters are freely available from the CRD website.
Contributions of authors
SF produced the first draft of the protocol. TY reviewed and commented on subsequent drafts. YL edited subsequent drafts. AS reviewed and commented on subsequent drafts. SA reviewed and commented on subsequent drafts. NW reviewed and commented on subsequent drafts.
All protocol authors read and approved the final protocol version.
Sources of support
Internal sources
No sources of support supplied
External sources
-
National Institute for Health Research (NIHR), UK.
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Incontinence. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, NHS or the Department of Health and Social Care.
Declarations of interest
In accordance with Cochrane's Commercial Sponsorship Policy, the following declarations are applicable for the three years prior to the publication date of this protocol.
SF has received honoraria from Boston Scientific Japan for consulting activities outside the submitted work. TY has received a research grant from the Japanese Society of Urolithiasis Research for supporting clinical researches conducted by TY. This does not relate to bladder training for overactive bladder (OAB). YL received a support fee from Roche for the Annual European Congress of Rheumatology in 2017; and now is receiving the Japanese government (MEXT) scholarship as a research student. AS has no known conflicts of interest. SA has received research grants from the Japanese Ministry of Education, Culture, Sports, Science and Technology; Japan Agency for Medical Research and Development; Takeda Science Foundation; Astellas; AstraZeneca; and Tosoh Corporation. He has also received honoraria from Janssen, AstraZeneca, Sanofi, Takeda, and Astellas. These do not relate to bladder training for OAB. NW has received research funds from the Japanese Ministry of Health Labor and Welfare, and the Japanese Ministry of Education, Science, and Technology. He has also received royalties from Sogensha and Advantage Risk Management. These do not relate to bladder training for overactive bladder.
New
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