A Cochrane review [Abstract] 1 included 8 small trials involving a total of 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Quantitative synthesis of data was not possible because of different outcome measures. Data from the individual trials showed no clear difference between devices (like tampon, sponge, plug), but with wide confidence intervals. One trial compared a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure.
Comment: The quality of evidence is downgraded by study quality (inadequate or unclear allocation concealment, no blinding), by inconsistency (heterogeneity in interventions and outcomes), and by imprecise results (limited study size for each comparison, short follow-up).
Primary/Secondary Keywords