Randomized trial of unilateral versus bilateral percutaneous tibial nerve stimulation for the treatment of overactive...

Optimizing overactive bladder (OAB) management has the potential to improve quality of life. We sought to determine whether bilateral was more effective than unilateral Percutaneuous Tibial Nerve Stimulation (PTNS) at improving OAB symptoms.

Participants were randomized to either bilateral or unilateral PTNS and followed for 12 weeks. OAB questionnaire short form (OABqSF) and Incontinence Impact questionnaire (IIQ) were administered at baseline and every 4 weeks through week 12. Participants also completed a 2-day voiding diary weekly. Our primary outcome was change in OABqSF from baseline to completion of study. Secondary outcomes included change in IIQ, number of daily voids, nocturia and incontinence episodes. Score changes were compared using ANOVA and pairwise t-test.

We randomized 36 women, mean age 68.7 (range 32-90) years. Overall, baseline OABqSF and IIQ scores were similar between the groups. Both groups showed significant improvement in OABqSF over time. 55.6% of participants in the unilateral group and 66.7% of participants in the bilateral group had improvement per OABqSF scores. While both groups showed improvement in IIQ, only the bilateral group's improvement was statistically significant. Although, the mean and median differences in OABqSF, IIQ, and incontinence episodes were lower in the bilateral group, the difference between the groups was not significant.

Both unilateral and bilateral PTNS led to significant decreases in OABqSF with a trend for more improvement in the bilateral group. IIQ score only improved in the bilateral group suggesting a potential benefit from bilateral use.

The trial was registered on clinicaltrials.gov, NCT03535857.