Soomro 2001 #.
Methods | RCT, ITT, cross‐over | |
Participants | n = 43 Age‐ mean 50 ± 15 years Sex: F:M 30:13 Inclusion: patients with a history of frequency, urgency and urge incontinence who had not previously been treated at the department, including some who had previously received treatment from a general practitioner at least 6 months before Exclusion: not specified | |
Interventions | I (43): oxybutynin, 2.5 mg BD, up to 5 mg TDS, orally
II (43): TENS, 20 HZ, 6 hours daily After 6 weeks of treatment in the first arm, patients were re‐assessed. Patients completed a post‐treatment side effects questionnaire. After a washout period of 2 weeks, patients were started on the second arm of treatment, and the same assessment was repeated after 6 weeks of treatment Total duration of study: 14 weeks |
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Outcomes | Numbers not improved during treatment: I: 20/40, II: 20/38 Number of voids per day N, mean (SD): I 43, 9 (SD 5), II 43, 9 (SD 4), P≤0.003 compared with baseline of 43, 11 (SD 5) Number of incontinence episodes: "no statistical difference between treatment arms" Number of micturitions per day: "statistically significant (p< 0.0001)" compared with baseline QoL: "No statistical difference found in any of the parameters of SF‐36" Adverse events: dry mouth, blurred vision, dry skin and skin irritation |
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Notes | Ref ID [ pending] Oxybutynin versus electric stimulation (TENS) Cross‐over | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention in the methods |
Allocation concealment (selection bias) | Unclear risk | No mention in the methods |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No mention in the methods |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes reported |