Intermittent self‐dilatation for urethral stricture disease in men
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The purpose of this review is to evaluate the clinical and cost‐effectiveness of intermittent self‐dilatation versus no intervention after urethral stricture surgery in the management of urethral stricture disease in men.
The primary comparison is:
1. intermittent self‐dilatation versus no intervention.
If intermittent self‐dilatation is found to be effective for improving symptoms and health‐related quality of life or reducing the risk of recurrent stricture, then secondary comparisons will be:
2. one regimen of intermittent self‐dilatation (e.g. catheterisation frequency or duration of programme) versus another;
3. one device to perform intermittent self‐dilatation versus another.
Background
Urethral stricture is the most common cause of difficulty passing urine in young and middle aged men. The prevalence varies worldwide but indicative numbers from North America are 200 per 100,000 for men in their 20s rising to 900 per 100,000 for men in their 70s (Santucci 2007). In the National Health Service in the United Kingdom urethral strictures account for 16,000 hospital admissions and 12,000 operations annually, at a cost of GBP 10M (Mundy 2010). Strictures have a tendency to recur after treatment, and the concept of intermittent self‐dilatation was popularised in the 1980s as a means of reducing the risk of recurrence (Lawrence 1988).
Description of the condition
A urethral stricture is a scar of the spongy erectile tissue that surrounds the anterior urethra. Gradual contraction of this scar constricts the urethral lumen leading to progressive lower urinary tract symptoms (LUTS), the hallmark of this condition. Any process that injures the urethra can cause a urethral stricture. In developed countries one in two strictures are iatrogenic (following catheterisation or endoscopic prostate surgery, for example) and in one in three cases no cause can be identified (Lumen 2009). The pattern of aetiology is different in developing countries where sexually transmitted infection and pelvic trauma are more likely to be responsible (Ahmed 1998).
For men who present for the first time with a urethral stricture the standard treatment is an operation called endoscopic urethrotomy. A cold blade mounted on an endoscope is passed into the urethra and the stricture is incised longitudinally through to the healthy tissue underneath. This incision allows the narrow section to expand, returning the urethra to an adequate diameter. The alternatives to endoscopic urethrotomy are simple blind dilatation, where the stricture is stretched with a set of lubricated dilators or sounds; and urethroplasty, where the diseased part of the urethra is exposed through a cut in the skin behind the scrotum and then reconstructed.
Depending on the site and length of the stricture, men undergoing their first endoscopic urethrotomy have somewhere between a 25% to 89% chance of their stricture recurring (Lauritzen 2009). Some men perform intermittent self‐dilatation after an operation with the aim of delaying the onset of symptoms and recurrence.
Description of the intervention
Intermittent self‐dilatation is a treatment for urethral stricture where the patient passes a catheter tube or rod‐shaped device into their urethra at regular intervals to prevent the stricture from coming back.
The intermittent self‐dilatation device can be the same type of sterile disposable catheter used by people who perform intermittent self‐catheterisation to empty their bladder.,There are cultural variations and a stainless steel chopstick was found to be safe and cost‐effective in Taiwan (Yu‐Hung Lin 2006). In principle, the device should be clean to minimise the risk of introducing infection; and it should have a low co‐efficient of friction to facilitate atraumatic passage.
It is usual for a healthcare professional to first teach the patient how to pass the intermittent self‐dilatation device safely. Once comfortable with the technique, men are given a programme of dilatation to follow at home. Men are usually advised to dilate more frequently to begin with (daily for example) and to lengthen the interval in a stepwise fashion thereafter. Intermittent self‐dilatation can continue for a fixed period or indefinitely depending on the stricture, the patient and the doctor recommending it as a treatment. There is no general consensus as to which device or programme of intermittent self‐dilatation works best.
How the intervention might work
Performing intermittent self‐dilatation regularly splints the urethra open. It might prevent the cut edges of a stricture from sticking together and contracting after an operation (Lawrence 1988).
Why it is important to do this review
Intermittent self‐dilatation is an invasive procedure with associated cost and morbidity (urinary tract infection for example). We do not know whether performing intermittent self‐dilatation after a urethral stricture operation is better than having a urethral stricture operation and then doing nothing afterwards.
This review focuses on intermittent self‐dilatation; there is another Cochrane review which focuses on dilatation, urethrotomy and urethroplasty (Wong 2012).
Objectives
The purpose of this review is to evaluate the clinical and cost‐effectiveness of intermittent self‐dilatation versus no intervention after urethral stricture surgery in the management of urethral stricture disease in men.
The primary comparison is:
1. intermittent self‐dilatation versus no intervention.
If intermittent self‐dilatation is found to be effective for improving symptoms and health‐related quality of life or reducing the risk of recurrent stricture, then secondary comparisons will be:
2. one regimen of intermittent self‐dilatation (e.g. catheterisation frequency or duration of programme) versus another;
3. one device to perform intermittent self‐dilatation versus another.
Methods
Criteria for considering studies for this review
Types of studies
Randomised and quasi‐randomised controlled trials in which at least one arm is a programme of intermittent self‐dilatation for urethral stricture.
Types of participants
Male patients of all ages with a urethral stricture. The urethral stricture may be at any site, of any length or aetiology.
Types of interventions
Intermittent self‐dilatation is a programme of repeated urethral self‐dilatation. All permutations of device, dilation frequency and programme duration are eligible for inclusion.
One arm of any eligible trial must involve allocation to a programme of intermittent self‐dilatation. The programme of intermittent self‐dilatation normally follows, and may be coupled to, an endoscopic intervention for urethral stricture. Where that is the case, intermittent self‐dilatation will be assessed independent of the operation preceding it. Comparison interventions are therefore: no treatment; and the programmes of intermittent self‐dilatation themselves.
Types of outcome measures
Primary outcomes
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Patient‐reported lower urinary tract symptoms (validated patient‐reported outcome measures (PROMs), symptom and bother scores)
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Patient‐reported health‐related quality of life (validated condition‐specific and generic utility measures)
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Risk of recurrence measured as length of time to reintervention, or number of men requiring reintervention
Secondary outcomes
Adverse events
Rates of:
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urinary tract infection;
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urethral trauma;
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hospitalisation.
Acceptability
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Rate of withdrawal from the programme of intermittent self‐dilatation
Cost‐effectiveness
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Additional treatment cost
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Incremental cost per quality‐adjusted life year (QALY)
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Other health economic outcomes
Other outcomes
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Those not specified but reported in eligible trials will be considered
Search methods for identification of studies
This review will draw on the search strategy developed for the Incontinence Review Group as a whole. Relevant trials will be identified from the Group's Specialised Register of controlled trials, which is described under the Incontinence Group's module in The Cochrane Library. The Register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL and handsearching of journals and conference proceedings.
Terms that will be used to search the Incontinence Group Specialised Register are:
({DESIGN.CCT*} OR {DESIGN.RCT*}) AND ({topic.urine.urethralStricture.})
(Searches of the keyword field of Reference Manager 12, Thomson Reuters).
No language or other limitations will be imposed.
Electronic searches
Urethral stricture disease lies outside the stated remit of the Cochrane Incontinence Review Group. To ensure inclusion of all relevant trials, the electronic databases CENTRAL, CINAHL, EMBASE, OpenSIGLE, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and Current Controlled Trials (including the UK National Research Register) will be separately interrogated with terms pertaining to urethral stricture disease. MEDLINE will be searched using the Cochrane highly sensitive search strategy. For more details please see Appendix 1.
Search terms will include:
· Urethral stricture
· Urethral stenosis
· Self‐dilat$
· Urethral dilat$
· Urethral sound$
· Self‐catheter$
Citations and abstracts will be examined by two independent review authors and reports of potentially relevant trials will be retrieved in full.
Searching other resources
Reference lists of identified trials and review articles will be searched to find further relevant trials not identified elsewhere.
Data collection and analysis
Selection of studies
Randomised and quasi‐randomised trials identified from the Specialised Register and electronic searches will be screened for eligibility and selected for inclusion by two independent review authors.
Disagreements within the review team will be referred to the editorial team.
Data extraction and management
Data relevant to the pre‐stated outcomes, characteristics of the study, interventions and participants will be extracted to data collection forms by two independent review authors.
Studies will be excluded from the analysis if they are not randomised or quasi‐randomised trials. These studies will be listed in a table 'Characteristics of excluded studies'.
Assessment of risk of bias in included studies
Two independent review authors will assess methodological quality using the Cochrane Collaboration tool for assessing risk of bias. The quality of the trials will be documented under the heading ‘description of trials’. Studies will not necessarily be excluded from analyses on the basis of methodological quality. However, studies found to have high risk of bias may be excluded from the overall estimate of treatment effect when reported in a sensitivity analysis.
The nature of intermittent self‐dilatation means that study participants cannot be blinded to the intervention.
Quality assessment
Two independent review authors will use the Grading of Recommendations Assessment, Development and Education (GRADE) system to rate the quality of evidence across the stated outcomes (Guyatt 2008).
Measures of treatment effect
Dichotomous data will be presented as risk ratios (RR) with 95% confidence intervals (CI). Continuous data will be presented as mean difference (MD), or standardised mean difference if different scales have been used, with 95% CI.
Dealing with missing data
We will seek clarification from the trialists where trial data are collected but are not fully reported, or the reported form is unsuitable for analysis in this review.
Assessment of heterogeneity
We will consider whether the clinical and methodological characteristics of the included studies are sufficiently similar to carry out a clinically meaningful meta‐analysis. The presence of statistical heterogeneity will be assessed through visual inspection of the data plots, the χ2 test for heterogeneity (< 10%) and the I2 statistic (> 50%) (Higgins 2003). Reasons for heterogeneity will be explored.
Assessment of reporting biases
Funnel plots will be used to identify reporting bias.
Data synthesis
Trial data will be handled according to the processes described in the Cochrane Handbook for Systematic Reviews of Interventions.
Where possible, data for each outcome will be aggregated from included studies in a formal meta‐analysis of treatment effect. Analyses will be carried out using the RevMan analyses software in Review Manager (RevMan). Data that can not be combined quantitatively will be assessed qualitatively.
Subgroup analysis and investigation of heterogeneity
Data permitting, we will carry out subgroup analysis by type of urethral stricture (that is site, length or aetiology) and preceding operation (that is endoscopic urethrotomy and blind dilatation).
If there is clinical or statistical heterogeneity, a random‐effects model can be used.
