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Invasive urodynamic studies for the management of LUTS in men with voiding dysfunction

  1. Keiran David Clement1,*,
  2. Helena Bevis2,
  3. Katherine Warren2,
  4. Marie Carmela M Lapitan3,
  5. Muhammad Imran Omar4,5,
  6. Marcus J Drake6

Editorial Group: Cochrane Incontinence Group

Published Online: 30 JUN 2014

DOI: 10.1002/14651858.CD011179


How to Cite

Clement KD, Bevis H, Warren K, Lapitan MCM, Omar MI, Drake MJ. Invasive urodynamic studies for the management of LUTS in men with voiding dysfunction (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 6. Art. No.: CD011179. DOI: 10.1002/14651858.CD011179.

Author Information

  1. 1

    University of Aberdeen, Cochrane Incontinence Group, Aberdeen, UK

  2. 2

    North Bristol NHS Trust, Southmead Hospital, Bristol, UK

  3. 3

    National Institutes of Health Manila, University of the Philippines Manila, Division of Urology, Manila, Philippines

  4. 4

    University of Aberdeen, Academic Urology Unit, Aberdeen, Scotland, UK

  5. 5

    London School of Hygiene and Tropical Medicine, London, UK

  6. 6

    University of Bristol, Bristol, UK

*Keiran David Clement, Cochrane Incontinence Group, University of Aberdeen, Aberdeen, AB25 2ZD, UK. keiran.clement.09@aberdeen.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 30 JUN 2014

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Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Invasive urodynamic investigations are commonly used in the diagnosis of lower urinary tract symptoms (LUTS) in men and in subsequent planning and management. Urodynamic investigations measure bladder pressure and urine flow rate during bladder filling and voiding to assess the function of the lower urinary tract and identify the cause(s) of urinary storage or voiding symptoms.

In the evaluation of LUTS in men, the aim of urodynamic tests is to objectively demonstrate physiological dysfunction while differentiating between possible causes of the symptoms, so that the most effective method of treatment can be selected. For men with voiding dysfunction, urodynamics are commonly used to differentiate among bladder outlet obstruction (BOO), detrusor underactivity (DUA) and detrusor overactivity (DOA) (Hosker 2009). It is thought to be important to distinguish between LUTS due to BOO and LUTS due to DUA, as this may influence management decisions specifically in relation to surgery for BOO. Some low-level evidence suggests that making this distinction is important, as clinical outcomes may be affected (Hosker 2009).

 

Description of the condition

 

Definitions and terminology

 

Lower urinary tract symptoms (LUTS)

LUTS may be divided into three categories depending on the phase of the micturition cycle affected.

  • Storage symptoms are those experienced during the storage phase and include frequency, nocturia, urgency (the symptoms of overactive bladder syndrome) and urinary incontinence (Abrams 2002).
  • Voiding symptoms are those arising during the voiding phase of the micturition cycle. These include slow stream, splitting or spraying, intermittency, hesitancy, straining and terminal dribble (Abrams 2002).
  • Postmicturition symptoms are those experienced immediately following micturition and include a feeling of incomplete emptying and post-micturition dribble (Abrams 2002).

This review will focus on the investigation of voiding dysfunction in men and therefore will primarily assess men with voiding and post-micturition symptoms. Storage symptoms, in particular urinary incontinence, are already the main focus of another Cochrane review (Clement 2013).

 

Voiding dysfunction

Voiding LUTS are experienced during the voiding phase (emptying the bladder) of micturition (Abrams 2002). The voiding phase of the micturition cycle alternates with the storage phase and is under voluntary brain control, leading to both contraction of the bladder wall and relaxation of the urethral sphincter. Voiding dysfunction is most commonly caused by poor contractility of the bladder wall in DUA or enlargement of the prostate gland in benign prostatic hyperplasia (BPH), leading to BOO.

Voiding dysfunction in men may have many different causes; it is important to differentiate between these causes to determine appropriate management.

  • BOO may be caused by anatomical or functional problems. The most common cause is benign prostatic enlargement (BPE), which compresses the urethral canal, leading to obstruction of the normal flow of urine. Other anatomical causes of BOO include bladder tumour, urethral stricture, prostatitis and foreign body (Oelke 2013). Functional causes of BOO include detrusor-sphincter dyssynergia, in which neuronal injury, such as that occurring in spinal injury, leads to inappropriate contraction of the internal urethral sphincter during voiding, leading to retention. Other causes include primary bladder neck obstruction and pelvic floor dysfunction (Dmochowski 2005). Bladder outlet obstruction may be accompanied by DOA as the bladder tries to compensate for resistance to outflow (see later).
  • DUA is defined as "detrusor contraction of reduced strength and/or duration, resulting in prolonged bladder emptying and/or failure to achieve complete bladder emptying within a normal time span" (Abrams 2002). It is thought to be multi-factorial in aetiology. "Primary" or "idiopathic" DUA is thought to be due to the natural age-related decrease in detrusor contractility. However, not everyone in this group will become clinically symptomatic. Other causes of DUA include BOO (secondary to chronic overstretching of the detrusor muscle, leading to muscle damage and hence an inability to contract) and diabetes mellitus (van Koeveringe 2011).

Voiding LUTS in men are a common problem. Several studies have demonstrated through autopsy that prevalence of histological BPH is around 10% for men in their 30s, 20% for men in their 40s, 50% to 60% for men in their 60s and 80% to 90% for men in their 70s and 80s (Roehrborn 2005). It is reported that among men 50 to 80 years of age, 90% suffer from voiding LUTS (NICE 2010). In one population-based study in the USA, it was reported that 6% of all men (n = 2125) over 40 years of age had isolated voiding dysfunction as defined by the International Prostate Symptom Score (IPSS). Nine percent of all men had mixed voiding and storage LUTS (Glasser 2007). It is important to note that these figures may not reflect the true scope of the problem, as men may not present to a healthcare professional or admit that they are troubled, because of embarrassment. Alternatively, some men may be affected but may not find these symptoms to be a problem. LUTS in men become more common with increasing age. They are also associated with obesity, diabetes mellitus and a genetic susceptibility (Parsons 2010).

 

Overactive bladder syndrome

Overactive bladder syndrome (OAB) is a diagnosis characterised by urinary urgency in the absence of urine infection. When demonstrable involuntary detrusor contractions associated with symptoms of OAB are observed during urodynamic studies, this is termed 'detrusor overactivity' (DOA) (Abrams 2002). Although not strictly a direct cause of voiding dysfunction, OAB is a major cause of LUTS in men. Therefore if present, OAB may influence a clinician's management plan for concomitant BOO, for example, by altering the likelihood of proceeding to surgery or counselling the patient about the chance of symptom resolution.

 

Description of the intervention

The term 'urodynamics' is commonly used to encompass a wide variety of physiological measurements of bladder and urethral function that aim to demonstrate a causal abnormality of storage and voiding. The term is often used interchangeably to signify multi-channel cystometry, but several tests, including non-invasive free flow rate testing, can be described as urodynamic tests.

Cystometry is an invasive method of investigation: At a minimum, a catheter must be inserted into the bladder. A range of measurements can be taken, including urinary flow rate; pressure within the urethra, bladder and abdomen; and electrical nerve recording (Gorton 1999). A significant number of study participants have reported that undergoing these investigations was embarrassing and painful for them (Gorton 1999; Shaw 2000). Nevertheless, cystometric studies have been invaluable in aiding our understanding of the physiological and pathophysiological processes involved in the development of voiding dysfunction (Chapple 2006).

When urodynamic studies are performed in men, the most important goal is to reproduce the symptoms, so that the causes of symptoms of voiding dysfunction and any associated storage abnormality can be determined. This is normally achieved first by asking the patient to urinate into a container that is used to measure the volume and rate of urine passed (uroflowmetry). The volume of urine contained in the bladder after urination (postvoid residual volume) can then be measured by an external ultrasound scan of the bladder or by catheterisation.

Next, a urinary catheter is normally inserted to fill the bladder with water, saline or contrast medium to allow controlled reproduction of symptoms. Bladder sensations during bladder filling are reported by patients, including a sensation of filling, a desire to void, urgency and a sense of discomfort or pain. Concurrently, various pressure measurements are taken during the phases of the micturition cycle by using fluid-filled lines connected to external transducers, or 'microtip' transducers, inserted into a body cavity. When the bladder is deemed to be “full” (cystometric capacity), the patient is given permission to void, so that urinary flow rates can be related to changes in pressure during bladder emptying; this is termed a 'pressure-flow study.' The main pressure measurements taken are:

  • intravesical pressure (pressure within the bladder; Pves); and

  • abdominal pressure (pressure within the abdominal cavity, normally measured transrectally by using a rectal catheter; Pabd).

Both of these measurements are needed to derive the detrusor pressure (Pdet), which is the difference between bladder and abdominal pressures (Pves - Pabd) and is computed throughout the test. Variation in these pressure measurements during the phases of the micturition cycle facilitates the diagnosis of various conditions, provided a high-quality study is achieved.

 

Other types of urodynamics

Videourodynamics is another method of assessing function by using synchronous x-ray or ultrasound imaging of the bladder with multi-channel cystometry. This live imaging of the bladder may be recorded for future review. Ambulatory urodynamics involves using portable devices to measure multi-channel cystometry carried out with natural bladder filling. This allows patients to carry out their normal activities of daily living while they are being urodynamically assessed.

Gas cystometry uses carbon dioxide as the medium for filling the bladder during the study. This approach has been found to be unreliable and is not now recommended (Homma 1999). Surface electromyography may be used as an indirect measure of pelvic floor and sphincter muscle contractility, but it is not commonly used in clinical practice.

 

Risks of invasive urodynamic tests

The main risks associated with urodynamic testing are those associated with the process of urethral catheterisation, such as dysuria (painful urination) and urinary tract infection (UTI). A separate Cochrane review addresses interventions to reduce the incidence of infection (Foon 2012). Urodynamic tests also require the use of sophisticated machines and technical expertise, both of which have cost implications for the healthcare system. Men may find testing to be an uncomfortable or embarrassing experience.

The reproducibility of cystometry as a diagnostic investigation has been called into question (Kortmann 2000; Sonke 2000), as have its specificity and sensitivity in differentiating between causes of LUTS (Belal 2006). It has been suggested that correlation between urodynamic findings and symptoms in men with LUTS may be poor (Eckhardt 2001).

 

How the intervention might work

The National Institute for Health and Care Excellence (NICE) in the UK recommends that men contemplating surgery for the treatment of LUTS should be offered invasive urodynamic investigations (NICE 2010).

A Committee of the International Consultation on Incontinence (ICI) in 2009 published a recent overview of the best scientific evidence with regard to the role of cystometry in the management of people with urinary incontinence or voiding difficulties (Hosker 2009). This overview advised that evidence demonstrating that invasive urodynamics improves clinical outcomes in men investigated for LUTS related to BOO and DOA is limited; nonetheless the ICI advised that the investigation should be performed before surgical intervention is provided (Hosker 2009). The research behind these recommendations is conflicting. Some studies have suggested that preoperative detection of DOA aided in the prediction of postoperative complications such as incontinence (Aboseif 1994; Monoski 2006; Seki 2006). Other evidence supports the contrary assertion that preoperative DOA does not predict postprostatectomy incontinence (Golomb 1999; Kleinhans 1999).

It is possible that one type of urodynamic investigation may provide more useful information than another. This issue has been addressed by studies comparing the utility of ambulatory urodynamics and conventional cystometry, particularly in determining the contribution of detrusor overactivity to LUTS in men. In one study, conventional urodynamics was compared with ambulatory urodynamics, and ambulatory urodynamics was found to be more sensitive in detecting DOA; however, this finding did not correlate with a better outcome (Robertson 1996).

 

Why it is important to do this review

The diagnostic accuracy of a test is normally determined by verifying test results against a reference ('gold') standard that defines true disease status. The diagnostic performance of cystometry cannot be assessed in this way, however, because no gold standard has been accepted. In the absence of a gold standard, there may be no alternative to evaluating whether the treatment response after cystometry leads to improved health gains compared with the treatment response based on tests that do not include cystometry.

Furthermore, these tests are not without cost: They are invasive and expensive and may produce adverse effects. For the financial year 2011-2012, in the National Health Service (NHS) in England, urodynamic testing for one patient on an outpatient basis was calculated to cost £147. This cost increased to £340 on a day-case basis. With regard to adverse effects, it is estimated that cystometry results in at least a 3% incidence of symptomatic UTI (Foon 2012).

The value of accurate diagnosis depends on the availability and effectiveness of appropriate treatments. It is of no clinical value unless it is known, for example, that cystometry can distinguish between a group for whom surgery is effective and another group for whom it is neither effective nor contraindicated, or for which management needs to be altered in a specific way.

The value of invasive urodynamic investigation in the diagnosis and management of men with voiding dysfunction complaining of LUTS is therefore uncertain.

This review addresses whether the extra information generated by invasive urodynamic testing influences clinical decision making regarding men with voiding dysfunction and LUTS, and particularly whether this leads to improvement in clinical and economic outcomes.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

To determine whether performing invasive urodynamic investigation, as opposed to other methods of diagnosis such as non-invasive urodynamics or clinical history and examination alone, improves the management of LUTS and voiding dysfunction in men. This goal will be achieved by critically appraising and summarising current evidence from randomised controlled trials related to better clinical outcomes and cost-effectiveness.

The following hypotheses will be tested.

  • Do invasive urodynamic investigations improve the clinical outcomes of men with voiding dysfunction?
  • Do invasive urodynamic investigations alter clinical decision making?
  • Is one type of invasive urodynamics better than another for improving the outcomes of management of LUTS due to voiding dysfunction and/or for influencing clinical decisions?
  • Do invasive urodynamic tests identify risk factors for an adverse outcome from surgery?

The following comparisons will be made.

  • Invasive urodynamic tests versus clinical management without invasive urodynamics.
  • One type of urodynamic test versus another.

Because a reference ('gold') standard investigation is not available for comparison, this review will not aim to determine whether invasive urodynamic studies are reliable tests for making a clinical diagnosis, nor whether one type of urodynamic study is better than another for this purpose.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

All randomised or quasi-randomised controlled trials on the management of voiding dysfunction in which men with symptoms were randomly assigned to invasive urodynamic testing in at least one arm of the study.

Studies that did not report clinical outcomes of LUTS management nor effects on clinical decision making will be excluded.

 

Types of participants

All men with voiding LUTS presenting for investigation and management of their LUTS, as defined by the trial authors.

 

Types of interventions

 

Interventions

Invasive urodynamic investigations used as part of a diagnostic work-up before management decisions are made. All types of urodynamics are eligible for consideration in this review (AHCPR 1996; Homma 1999), including the following.

  • Cystometry (simple, multi-channel or subtracted: study of the pressure/volume relationship of the bladder during urine storage (filling cystometry) and urine expulsion (voiding cystometry)).
  • Pressure-flow studies of voiding (study of the bladder pressure/urine flow rate relationship during voiding).
  • Urethral pressure measurements (profilometry: measurement of pressure within the urethra; urethral closure pressure is defined as the difference between intraluminal pressure in the urethra and intravesical pressure in the bladder at rest or during stress such as coughing or straining.
  • Leak point pressure measurements (pressure within the bladder at which leakage of urine from the urethra occurs: a direct measure of the closure function of the entire urethra).

  • Penile cuff test (non-invasive measurement of bladder pressure during voiding, taken by intermittent occlusion of the urinary stream with an inflatable cuff placed around the penis).
  • Electromyography (direct measurement of the contractility of muscles concerned with continence, i.e. urethral sphincter, anal sphincter or pelvic floor muscles).
  • Videourodynamics (radiological (x-ray) imaging and urodynamic measurements of the lower urinary tract performed simultaneously during filling and voiding).
  • Ambulatory urodynamic monitoring (urodynamic test performed with natural bladder filling under circumstances in which the patient's mobility is minimally restricted).

Cystoscopy and imaging tests (radiography, ultrasonography) are not usually considered routine urodynamic tests and will not be included in this review.

Although the specific management decisions made and the treatments that patients undergo following assessment with or without urodynamics are not included among the interventions assessed in this review, it is important to note that it is the outcome of these for which the usefulness of urodynamics is to be judged. Therefore, to minimise bias associated with systematic differences in care between centres or treatment modalities, included studies will be assessed for statements that diagnostic procedures and subsequent interventions have been carried out to an internationally accepted high standard. Furthermore, in trials in which a new intervention is being deployed, statements regarding whether training and learning curves have been concluded before the start of the trial will be sought.

 

Comparators

Investigations that do not include invasive tests, such as:

  • clinical history;
  • physical examination;
  • symptoms reported on enquiry or by questionnaire;
  • uroflowmetry and residual volume measurement;
  • urinary diaries; and
  • pad tests.

Uroflowmetry and residual urine measurement (recording the volume of fluid expelled via the urethra per unit time during voiding; and the volume of urine left in the bladder after voiding) can be considered as part of urodynamic testing, but alone, they are not by definition invasive and therefore will not be considered as a comparator in this review unless they are used in conjunction with other invasive urodynamic tests. This will allow determination of whether it is urodynamic studies as a whole, or mainly the uroflowmetry and residual urine measurement (non-invasive) portions of the study, that influence decisions and outcomes.

 

Types of outcome measures

Outcome measures used in this review were selected on the basis of their relevance to the clinical cure of or improvement in LUTS in men with voiding dysfunction, or to the management decisions that are made to address this problem. The primary outcomes of this review are regarded as clinical ones, as assessed by symptoms, questionnaire (e.g. IPSS) or urinary diary. In addition, the effect of invasive urodynamic testing in influencing clinical decisions was quantified. Studies that did not report clinical outcomes or effects on clinical decision making will be excluded.

We will adopt the recommendations provided by the Standardisation Committee of the International Continence Society for outcomes of research investigating the effects of therapeutic interventions for people with voiding dysfunction or urinary incontinence. These outcome categories include observations (symptoms) of people investigated for voiding dysfunction, quantification of symptoms, the clinician's observations (anatomical and functional), quality of life and socioeconomic measures (Lose 1998).

Data could be obtained from history and questionnaire assessment, or from urinary diaries (including frequency of micturition and voided volumes).

The review will also include adverse events as outcome measures.

The ideal minimum follow-up for our primary outcome and for other relevant clinical outcomes will be one year following urodynamics. Should trials report follow-up of different length for each outcome, each will be analysed separately.

 

Primary outcomes

Number of men with continuing symptoms of voiding dysfunction after treatment following assessment with and without urodynamic studies.

 

Secondary outcomes

 
Clinical decision making

  • Number of men receiving conservative, drug or surgical treatment.
  • Number of men whose treatment was changed after invasive urodynamics.
  • Need for repeat or alternative treatment.

 
Participant observations

  • Number of men with no improvement in symptoms of voiding dysfunction as defined by the authors of each trial.
  • Symptom scores (e.g. IPSS).
  • Overactive bladder symptoms (urgency, frequency, nocturia).
  • Urinary incontinence.
  • Use of pads.
  • Satisfaction with treatment.
  • Time to return to normal activity.

 
Quantification of associated symptoms

  • Frequency of micturition.
  • Nocturia.
  • Urine flow rate.
  • Voided volumes.

 
Clinician observations (anatomical and functional)

  • Clinician-observed urinary incontinence.
  • Need for further treatment.

 
Adverse effects

  • Adverse events due to the method of investigation (e.g. UTI after urodynamic investigation).
  • Adverse events due to subsequent clinical management.
  • Deaths.

 
Quality of life

  • General health status measures (physical, psychological, other).
  • Condition-specific health measures (specific instruments designed to assess the effect of voiding dysfunction on quality of life).
  • Psychological health status measures e.g. Hospital Anxiety and Depression Score (HADS).

 
Economic outcomes

  • Health economic measures.
  • Costs of investigations.
  • Costs of treatment and retreatment.

 
Other outcomes

  • Non-prespecified outcomes judged important while conducting the review.

 
Quality of evidence

Primary and secondary outcomes, as defined above, were classified by the review authors as 'critical,' 'important' or 'not important' for decision making from the participant's perspective. The GRADE working group strongly recommends including up to seven outcomes in a systematic review. In this systematic review, GRADE methodology will be adopted for assessing the quality of available evidence for the following outcomes.

  • Number of men with continuing symptoms of voiding dysfunction after treatment following assessment with and without urodynamic studies.
  • Incidence of UTI.
  • Subjective participant satisfaction with treatment at three months following treatment.
  • Need for repeat or alternative treatment within one year.
  • Health outcome measures such as quality-adjusted life-years (QALYs).

 

Search methods for identification of studies

We will not impose language, status of publication or other limits on the searches described below, unless otherwise stated.

 

Electronic searches

We will search the following electronic bibliographic databases, all on Ovid SP.

  • Cochrane Central Register of Controlled Trials (CENTRAL) (most recent issue). The search strategy is given in Appendix 1.
  • MEDLINE (1946 to present) and MEDLINE In-Process and other non-indexed citations. The search strategy is given in Appendix 2.
  • EMBASE Classic and EMBASE (2010 to present). Explanations for the date limitation and the search strategy are given in Appendix 3.

Ongoing trials and trial results will be sought in the following trial results registers and platforms. The search terms to be used are given in Appendix 4.

  • ClinicalTrials.gov (most recent version).
  • World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (most recent version).

The search terms tested but rejected (as they did not lead to retrieval of any relevant records during testing) are given in Appendix 5.

 

Searching other resources

We will search the reference lists of relevant articles.

 

Data collection and analysis

Studies will be excluded if they were not randomised or quasi-randomised trials for men with voiding dysfunction. In addition, studies that do not report clinical outcomes or an effect on clinical decision making will be excluded. Excluded studies will be listed along with details of the interventions compared and the reasons for their exclusion.

Included data will be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

 

Selection of studies

Reports of all possibly eligible studies will be evaluated for methodological quality and appropriateness for inclusion by two review authors independently without prior consideration of the results. Disagreements will be resolved by discussion. When these are not resolved, arbitration will rest with a third person.

 

Data extraction and management

Data extraction will be undertaken independently by at least two review authors and cross-checked by using a customised data collection form. When data may have been collected but are not reported, clarification will be sought from the trialists. Included trial data will be processed using RevMan software, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Authors of original reports will be contacted for extra information and data if required.

 

Assessment of risk of bias in included studies

Critical appraisal and assessment of risk of bias will be undertaken by each review author independently, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). The following will be assessed and reported in the Cochrane risk of bias tables.

  • Selection bias: Was the allocation sequence adequately generated?
  • Selection bias: Was allocation adequately concealed?
  • Performance bias: Was knowledge of the allocated intervention adequately prevented during the study?
  • Detection bias: Was knowledge of the allocated intervention adequately prevented during outcome assessment?
  • Attrition bias: Was there differential dropout from the randomly assigned groups, and were incomplete outcome data adequately addressed?
  • Selective outcome reporting: Are reports of the study free of any suggestion of selective outcome reporting (or, were all relevant outcomes adequately reported)?
  • Other sources of bias: Are there any other aspects of the trials that may put them at risk of bias, as judged by the review authors?

Studies will be considered to be at low risk of bias if the method of blinding was adequate, or if we judge that lack of blinding could not have affected the results or could not be avoided. Each element was assessed as low risk, high risk or unclear risk of bias (the latter usually when no information was supplied).

 

Measures of treatment effect

For categorical outcomes, we will relate the numbers reporting an outcome to the numbers at risk in each group to derive a summary risk ratio (RR). For continuous variables, we will use means and standard deviations to derive a mean difference (MD) if outcomes were measured in the same way between trials. Continuous data that are the product of a number of different scales (e.g. scales used to assess symptoms such as pain or quality of life) will be summarised as the standardised mean difference (SMD) by using a fixed-effect model. A fixed-effect model will be used for calculation of all summary estimates and 95% confidence intervals (CIs) except when heterogeneity is significant. When appropriate, meta-analysis will be undertaken.

 

Unit of analysis issues

If relevant, studies with non-standard design, such as cross-over trials and cluster-randomised trials, will be analysed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Studies with multiple treatment groups will be analysed by treating each pair of arms as a separate comparison, as appropriate.

 

Dealing with missing data

We define an intention-to-treat analysis to mean that all participants are analysed in their randomly assigned groups, whether or not they receive the allocated intervention. We will include data as they are reported by the trialists for each outcome and will not impute missing values. However, we will carry out sensitivity analyses if differential dropout from the randomly assigned groups is noted, or if systematic bias from missing data is suspected for another reason.

 

Assessment of heterogeneity

Trial data will be combined only if there is no reason to suspect clinical heterogeneity. Differences between trials will be investigated if significant heterogeneity is found from the Chi2 or the I2 statistic (Higgins 2003) or is obvious from visual inspection of the results and data plots. Visual heterogeneity will be deemed positive when the confidence intervals of studies do not overlap. This will then be confirmed by formal statistical testing. Statistical heterogeneity is regarded as substantial if I2 is greater than 50%, as reported by the Cochrane Handbook for Systematic Reviews of Interventions, or if the P value (< 0.10) in the Chi2 test for heterogeneity is low. For those outcomes, a random-effects model can be used.

 

Assessment of reporting biases

Publication bias will be examined by funnel plot if 10 or more studies are included in a meta-analysis.

 

Data synthesis

Fixed-effect analysis will be used to carry out meta-analyses except when significant heterogeneity is suspected, when a random-effects model can be used.

 

Subgroup analysis and investigation of heterogeneity

We plan to carry out subgroup analysis on the following groups if the data allow.

  • Men in the following age groups: younger than 50 years of age, 50 to 80 years of age and older than 80 years of age.

  • Men undergoing a primary versus a secondary investigation after failed treatment.

  • Men presenting with and without additional storage LUTS.

  • Men in urinary retention (i.e. with a catheter in situ) or not.

  • Men with different causes of voiding dysfunction (e.g. BPE, other).

 

Sensitivity analysis

We could carry out sensitivity analysis based on eligibility criteria, such as by including and excluding results from abstract-only publications if enough trials are identified (Deeks 2011).

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

We thank the external referees and the Editors of the Cochrane Incontinence Review Group, who made helpful comments on the content and text of the review.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Appendix 1. CENTRAL search strategy

The following strategy will be run in CENTRAL on Ovid SP (most recent version).

1. urodynamics/
2. urodynamic*.tw.
3. 1 or 2

 

Appendix 2. MEDLINE and MEDLINE In-Process search strategy

The following strategy will be run in MEDLINE from 1946 to the present and in MEDLINE In-Process (most recent version), both on Ovid SP.

1. controlled clinical trial.pt.
2. randomized controlled trial.pt.
3. randomized controlled trials/
4. random allocation/
5. double blind method/
6. single blind method/
7. clinical trial.pt.
8. exp clinical trial/
9. placebos/
10. placebo$.tw.
11. random$.tw.
12. research design/
13. volunteer$.tw.
14. (clin$ adj25 trial$).tw.
15. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw.
16. factorial.tw.
17. cross-over studies/
18. crossover.tw.
19. latin square.tw.
20. (balance$ adj2 block$).tw.
21. trial.ti.
22. (animals not humans).sh.
23. or/1-21
24. 23 not 22
25. urodynamics/
26. urodynamic*.tw.
27. 25 or 26
28. 24 and 27

 

Appendix 3. EMBASE search strategy

The following search strategy will be run on EMBASE (1947 to present) on Ovid SP but limited to entry month 2010 onwards, as at the present time, The Cochrane Collaboration's centralised search of EMBASE, for inclusion in CENTRAL, is only fully complete for 1974 to 2009 inclusive. (The 2010 conference abstracts are not covered, and for 2011, all record types are not at present covered by The Cochrane Collaboration's centralised search) (all 2012 and 2013 records are due in CENTRAL at the end of January 2014).

1. Randomized Controlled Trial/
2. controlled study/
3. clinical study/
4. major clinical study/
5. prospective study/
6. meta analysis/
7. exp clinical trial/
8. randomization/
9. crossover procedure/ or double blind procedure/ or parallel design/ or single blind procedure/
10. Placebo/
11. latin square design/
12. exp comparative study/
13. follow up/
14. pilot study/
15. family study/ or feasibility study/ or pilot study/ or study/
16. placebo$.tw.
17. random$.tw.
18. (clin$ adj25 trial$).tw.
19. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).tw.
20. factorial.tw.
21. crossover.tw.
22. latin square.tw.
23. (balance$ adj2 block$).tw.
24. factorial design/
25. parallel design/
26. triple blind procedure/
27. community trial/
28. intervention study/
29. experimental study/
30. prevention study/
31. quasi experimental study/
32. or/1-31
33. (nonhuman not human).sh.
34. 32 not 33
35. urodynamics/
36. urodynamic*.tw.
37. 35 or 36
38. 34 and 37
39. 201*.em.
40. 38 and 39

 

Appendix 4. ClinicalTrials.gov and WHO ICTRP search strategy

In both ClinicalTrials.gov and WHO ICTRP, the following term will be entered into the standard search line.

urodynamic*

 

Appendix 5. Potential search terms tested but rejected

The following terms were tested in MEDLINE (1946 to November weeks 2 and 3 2013, between 26 and 28 November 2013), MEDLINE In-Process and other non-indexed citations (27 November 2013 on 30 November 2013) and CENTRAL, 2013, Issue 10, on 30 November 2013 (all on Ovid SP) but were rejected, as no relevant records were retrieved during testing.

Diagnostic Techniques, Urological/
cystomet*.tw.
cystoman*.tw.
cystoton*.tw.
urethrocystomet*.tw.
urethrograph*.tw.
postvoid residual*.tw.
Post void residual*.tw.
urinary flow rate.tw.
uroflowmet*.tw.
uroflomet*.tw.
urin* adj2 flowmet*.tw.
urinomet*.tw.
pressure-flow stud*.tw.
Pves.tw.
Pdet.tw.
videourodynamic*.tw.
profilomet*.tw.
urethra* pressure*.tw.
Leak point pressure*.tw.
electromyograph* adj2 urethra*.tw.
void* adj2 dynamic*.tw.
urological diagnostic device*.tw.

In EMBASE Classic and EMBASE 1947 to 2013 week 47 on 2 December 2013 and 1947 to 2013 week 49 on 12 December 2013 (on Ovid SP), as well as the terms tested above, the following terms were tested but rejected, as no relevant records were retrieved during testing.

urological examination/
exp cystometer/
urethrograph/
urine flowmeter/
exp urinometer/
exp uroflowmetry/
urine flowrate/
cystometry/
exp cystourethrography/
urological diagnostic device/

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

All review authors contributed to the writing of this protocol.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

None.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Internal sources

  • No sources of support supplied

 

External sources

  • The National Institute for Health Research (NIHR), UK.
    The National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Incontinence Review Group. 
    Disclaimer:
    The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the NIHR, the NHS or the Department of Health.

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
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