Percutaneous tibial nerve stimulation versus sham efficacy in the treatment of refractory overactive bladder: outcomes following a shortened 6-week protocol, a prospective randomized controlled trial.

Purpose: It is a prospective randomized controlled trial comparing the efficacy of percutaneous tibial nerve stimulation versus sham for a shortened 6-week protocol of treatment in management of refractory OAB in non-neurogenic adult patients.

Methods: A total of 50 adults with refractory non-neurogenic overactive bladder symptoms were randomized 1:1 to 6 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder symptom score as well as 3-day voiding diaries were completed at baseline and at 7th week, 3rd and 6th month.

Results: The 7th week, 3rd and 6th month symptom score assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation patients achieved statistically significant improvement in bladder symptoms with 52% reporting moderately improved responses compared to non-response of sham patients from baseline (P = 0.001). Voiding diary parameters after 6 weeks of therapy showed that PTNS patients had statistically significant improvements in frequency, voided volume and urgency urinary incontinence episodes compared to sham. No serious device-related adverse events or malfunctions were reported.

Conclusion: A shortened 6-week treatment protocol with PTNS appears to be successful and more effective than sham in the treatment of refractory OAB. PTNS therapy is safe and effective in treating OAB symptoms with 52% success rate following a shortened 6-week protocol. The duration of treatment with PTNS can be halved compared to the conventional 12 weeks, which would make it more acceptable and cost effective for patients.