OBJECTIVE: The objective of this review is to compare the efficacy of PTNS to a validated sham in subjects who have previously used OAB pharmacologic therapy.
METHODS: A multi-center, double-blinded trial enrolled 220 subjects; 110 randomized to PTNS, and 110 randomized to a validated sham intervention. This analysis includes only those subjects who previously used OAB pharmacologic therapy prior to their participation in the study; 68.1% (150/220) subjects, 73 randomized to PTNS and 77 to sham. An average of 2 OAB drugs had been used by subjects in both arms. Duration of drug therapy varied across subjects and across medications; however, overall mean duration was similar between groups; 16.2 months in PTNS group (0.3mo - 97mo) and 15.6 months in sham group (0.3mo - 168mo).
RESULTS: The Global Response Assessment (GRA) found 62.9% (44/70) were responders (moderately or markedly improved) in the PTNS group compared to 20.3% (15/74) in the sham group (p ≤ 0.001). The PTNS group also had statistically significant improvement for urinary frequency, urgency, and urge incontinence on the GRA compared to sham group (p ≤ 0.05).Voiding diary parameters after 12 weeks found the PTNS group had statistically significant improvement compared to sham for frequency, nighttime voids, urge incontinence and moderate to severe urgency. No serious adverse effects were noted in either group.
CONCLUSION: The results of this cohort provides strong scientific evidence that the therapeutic effect of PTNS is due to the stimulation of the posterior tibial nerve and is not due to a placebo effect and is effective in those previously exposed to pharmacological treatment.
Source: Original Presentation