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. 2014 Dec 19;2014(12):CD010258. doi: 10.1002/14651858.CD010258.pub2

Sallami 2011.

Methods Full text.
August 2005 ‐ February 2008.
Objective: compare intermittent self‐dilatation after optical urethrotomy for urethral stricture using a low‐friction hydrophilic catheter (LoFric) or standard Nelaton polyvinyl chloride (PVC) catheter.
States block randomisation.
Statistical methods: Life table, log rank, Chi2.
Participants Tunisia.
62 men with anterior or posterior urethral stricture < 2cm.
Age: range 21‐86; mean Control 60.9, Treatment 62
Exclusions: prostate or bladder cancer, patients requiring antibiotic prophylaxis, need for CISC for bladder drainage, incapable of following study protocol.
Interventions Control: optical urethrotomy then intermittent self‐dilatation with Nelaton catheter (n = 31).
Treatment: optical urethrotomy then intermittent self‐dilatation with LoFric catheter (n = 31).
Outcomes PROs:
Ease of use after 6 catheter insertions: 5‐item VAS non‐validated questionnaire (trouble, convenience, pain, comfort, general opinion).
Mean pain, comfort and opinion scores favoured LoFric; trouble and convenience NS.
Health economic: no
Adverse events:
Control: 7 (1 prostatitis, 2 bleeding, 4 positive urine culture)
Treatment: 1 positive urine culture
Acceptability:
Number of men who considered the treatment acceptable.
Means of assessment of acceptability to patients not described.
Control: 7/28
Treatment 30/31
Recurrence rate:
Definition of recurrence: flow rate < 14 ml/s
Number of men with recurrent urethral stricture 2 years after optical urethrotomy.
Control: 7/28
Treatment: 2/31
P = 0.15
Time to recurrence: no.
Notes intermittent self‐dilatation programme: twice monthly for 3 months then monthly for 1 year
Witdrawals: n = 3 Nelaton arm (1 DNA, 2 rUTI).
Authors conclude: LoFric catheter significantly increased the degree of comfort and satisfaction and decreased the feeling of pain when the catheter was removed or inserted, when compared with a conventional PVC catheter.
Note: Results state only 10/31 in treatment arm able to perform intermittent self‐dilatation at home without problems.
Subgroups: no.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk States block randomisation. No further details.
Allocation concealment (selection bias) High risk Not stated. 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 Unclear risk 3 control group patients withdrawn (2 UTI, 1 DNA); none from the treatment group.
Selective reporting (reporting bias) High risk Time to first recurrence analysis stated in Methods but not reported in Results.
Results conflict with statement that only 10/31 in treatment arm able to perform intermittent self‐dilatation at home without problems.
Funding/COI Unclear risk Not stated.