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. |
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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. |
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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). |
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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. |
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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. |
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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. |