Matanhelia 1995.
Methods | Full text. 1989‐1991. No stated objective. States randomly allocated; no details. Statistical methods: Log rank x2 |
|
Participants | UK. 51 men with anterior urethral stricture. Age: not stated. Exlcusions: not stated. |
|
Interventions | Control: optical urethrotomy (n = 21) Treatment: optical urethrotomy then intermittent self‐dilatation for 3 months (n = 23) |
|
Outcomes |
PROs: no Health economic: no Adverse events: Zero UTI intermittent self‐dilatation arm. Quote 'none developed urinary tract infections.' Acceptability: No objective assessment. Quote 'patients generally found the procedure acceptable.' Recurrence rate: Number of men with recurrent urethral stricture 12 months after optical urethrotomy. Definition of recurrence: flow rate < 12 ml/s. Control: 8/21 Treatment: 6/23 Time to recurrence: no |
|
Notes | intermittent self‐dilatation programme: twice daily for 2 weeks, daily for 3 weeks, twice weekly for 3 weeks, weekly for 4 weeks. Withdrawals: 7 (6 DNA, 1 death); not stratified by arm. Subgroups: First or recurrent stricture. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: 'Patients were randomly allocated.' No further details. |
Allocation concealment (selection bias) | High risk | Not described. Probably not done. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not stated. Probably not done. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 6/51 patients entered into the trial did not attend follow‐up, allocation unspecified. Sufficient to impact on intervention effect. |
Selective reporting (reporting bias) | High risk | No pre‐stated objective. UTI data incompletely reported. |
Funding/COI | Unclear risk | Not stated. |