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. 2012 Dec 12;2012(12):CD003193. doi: 10.1002/14651858.CD003193.pub4

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
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
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