Khan 2011.
| Methods | Full text. June 2007 ‐ June 2010. Objective: determine the role of intermittent self‐dilatation in the prevention of recurrence of urethral stricture after optical urethrotomy; study the frequency of postoperative complications and tolerability of intermittent self‐dilatation. States randomised; no details. |
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| Participants | Pakistan. 60 men with anterior urethral stricture. Age: range 20‐38; mean Control 37.3, Treatment 42.5 Exclusions: prostate or bladder cancer, inability to learn intermittent self‐dilatation. |
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| Interventions | Control: optical urethrotomy (n = 30) Treatment: optical urethrotomy then intermittent self‐dilatation for 1 year (n = 30) |
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| Outcomes |
PROs: no. Health economic: no. Adverse events: Control: 3 UTI; 1 epididymitis Treatment: 4 UTI, zero epididymitis. Acceptability: no objective assessment. Quote 'All of the patients who completed the prescribed CISC program considered the method fully acceptable.' Recurrence rate: Number of men with recurrent urethral stricture 12 months after optical urethrotomy. Definition of recurrence: cystoscopy. Control: 12/26 Treatment: 4/22 P < 0.01 Time to recurrence: no |
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| Notes | intermittent self‐dilatation: twice a day for 1 week, once a day for 4 weeks, then weekly for one year. Withdrawals: Control: 4 (2 DNA, 1 emigration, 2 symptomatic declined cystoscopy) Treatment: 8 (4 DNA, 1 death, 3 unable to perform intermittent self‐dilatation) Subgroups: no. Large sections of this paper including the results are described verbatim in Kjaergaard 1994; numbers similar. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote 'randomly divided into treatment group and control group.' Insuffucient information to make judgement. |
| Allocation concealment (selection bias) | High risk | Not stated. Probably not done. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Not stated. Impossible to blind participants. Outcome assessors probably not blind. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Number of participants withdrawn from treatment arm enough to impact effect estimate. |
| Selective reporting (reporting bias) | Low risk | Expected outcomes reported. |
| Funding/COI | Unclear risk | Not stated. |