Asking men to pass a catheter into their own urethra to try to stop a urethral stricture from coming back

BACKGROUND

About one in 300 men are affected by a condition called urethral stricture where part of the urethra scars causing it to become narrow. Most urethral strictures are caused by injury or infection. The main symptom is difficulty passing urine. In at least half of patients, urethral strictures come back within two years after they have a surgical operation called optical urethrotomy to stretch their urethral stricture. For this reason there is considerable interest in finding ways to reduce the chance of a urethral stricture coming back.

Intermittent self-dilatation is a treatment designed to stop urethral strictures returning. The man passes a thin, usually disposable, catheter tube into the urethra himself at regular intervals to try to keep the scarred area from narrowing down again. It is thought to work by preventing the cut edges of a stricture from sticking together, but there are some risks including infection and injury to the urethra.

We do not know whether intermittent self-dilatation is a good treatment for urethral stricture.

STUDY CHARACTERISTICS

We found 11 trials involving a total of 776 men across eight countries for this review.

KEY RESULTS

A combination of results from six trials involving a total of 404 participants indicated that men with urethral stricture who perform intermittent self-dilatation may have less chance of their urethral stricture coming back than men with a urethral stricture who do not perform intermittent self-dilatation. We can not be confident about this finding, however, because the quality of the evidence was very low.

There were no trials that looked at whether intermittent self-dilatation is a cost-effective health care intervention and there were no trials that used reliable health questionnaires to find out whether intermittent self-dilatation reduces men's urinary symptoms or improves their overall well being.

On the whole the trials did not report side effects in a way that was useful for estimating the risks of performing intermittent self-dilatation.

We do not know yet whether certain types of catheter are better than others for performing intermittent self-dilatation. It is also unclear how often or for how long men should perform intermittent self-dilatation to give themselves the best chance of staying free from urethral strictures.

QUALITY OF THE EVIDENCE

The trials in this review were generally small and poorly designed or poorly explained. All of the trials were conducted in a way which meant they had a high chance of generating an answer that does not represent the truth.

Authors' conclusions: 

Performing intermittent self-dilatation may confer a reduced risk of recurrent urethral stricture after endoscopic treatment. We have very little confidence in the estimate of the effect owing to the very low quality of the evidence. Evidence for other comparisons and outcomes is limited. Further research is required to determine whether the apparent benefit is sufficient to make the intervention worthwhile, and in whom.

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Background: 

Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically effective or cost-effective intervention in the management of this disease.

Objectives: 

The purpose of this review is to evaluate the clinical effectiveness and cost-effectiveness of intermittent self-dilatation after urethral stricture surgery in males compared to no intervention. We also compared different programmes of, and devices for, intermittent self-dilatation. .

Search strategy: 

We searched the Cochrane Incontinence Group Specialised Register (searched 7 May 2014), CENTRAL (2014, Issue 4), MEDLINE (1 January 1946 to Week 3April 2014), PREMEDLINE (covering 29 April 2014), EMBASE (1 January 1947 to Week 17 2014), CINAHL (31 December 1981 to 30 April 2014) OpenGrey (searched 6 May 2014), ClinicalTrials.gov (6 May 2014), WHO International Clinical Trials Registry Platform (6 May 2014), Current Controlled Trials (6 May 2014) and the reference lists of relevant articles.

Selection criteria: 

Randomised and quasi-randomised trials where one arm was a programme of intermittent self-dilatation for urethral stricture were identified. Studies were excluded if they were not randomised or quasi-randomised trials, or if they pertained to clean intermittent self-catheterisation for bladder emptying.

Data collection and analysis: 

Two authors screened the records for relevance and methodological quality. Data extraction was performed according to predetermined criteria using data extraction forms. Analyses were carried out in Cochrane Review Manager (RevMan 5). The primary outcomes were patient-reported symptoms and health-related quality of life, and risk of recurrence; secondary outcomes were adverse events, acceptability of the intervention to patients and cost-effectiveness. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Main results: 

Eleven trials were selected for inclusion in the review, including a total of 776 men. They were generally small; all were of poor quality and all were deemed to have high risk of bias.

Performing intermittent self-dilatation versus not performing intermittent self-dilatation

The data from six trials were heterogeneous, imprecise and had a high risk of bias, but indicated that recurrent urethral stricture was less likely in men who performed intermittent self-dilatation than men who did not perform intermittent self-dilatation (RR 0.70, 95% CI 0.48 to 1.00; very low quality evidence). Adverse events were generally poorly reported: two trials did not report adverse events and two trials reported adverse events only for the intervention group. Meta-analysis of the remaining two trials found no evidence of a difference between performing intermittent self-dilatation and not performing it (RR 0.60, 95% CI 0.11 to 3.26). No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness.

One programme of intermittent self-dilatation versus another

We identified two trials that compared different durations of intermittent self-dilatation, but data were not combined. One study could not draw robust conclusions owing to cross-over, protocol deviation, administrative error, post-hoc analysis and incomplete outcome reporting. The other study found no evidence of a difference between intermittent self-dilatation for six months versus for 12 months after optical urethrotomy (RR 0.67, 95% CI 0.12 to 3.64), although again the evidence is limited by the small sample size and risk of bias in the included study. Adverse events were reported narratively and were not stratified by group. No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness.

One device for performing intermittent self-dilatation versus another

Three trials compared one device for performing intermittent self-dilatation with another. Results from one trial at a high risk of bias were too uncertain to determine the effects of a low friction hydrophilic catheter and a standard polyvinyl chloride catheter on the risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40). Similarly one study did not find evidence of a difference between one percent triamcinolone gel for lubricating the intermittent self-dilatation catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). Two trials reported adverse events, but one did not provide sufficient detail for analysis. The other small study reported fewer instances of prostatitis, urethral bleeding or bacteriuria with a low friction hydrophilic catheter compared with a standard polyvinyl chloride catheter (RR 0.13, 95% CI 0.02 to 0.98). ‘Happiness with the intervention’ was assessed using a non-validated scale in one study, but no trials formally assessed patient-reported health-related quality of life or acceptability. No trials reported on patient-reported lower urinary tract symptoms or cost-effectiveness.

GRADE quality assessment

The evidence that intermittent self-dilatation reduces the risk of recurrent urethral stricture after surgical intervention was downgraded to 'very low' on the basis that the studies comprising the meta-analysis were deemed to have high risk of bias, and the data was imprecise and inconsistent.

Insufficient evidence

No trials provided cost-effectiveness data or used a validated patient-reported outcome measure, and adverse events were not reported rigorously. Acceptability of the intervention to patients has not been assessed quantitatively or qualitatively.

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