Patient-reported outcomes in the setting of a randomized control trial on the efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome

Aim: To compare the efficacy of transcutaneous tibial nerve stimulation (TTNS) with percutaneous tibial nerve stimulation (PTNS) regarding patient-reported outcomes measures, specifically quality-of-life (QoL) improvement and patient's treatment benefit, on symptoms associated with overactive bladder (OAB). Methods: Patients with refractory OAB symptoms and detrusor overactivity were randomized to receive TTNS or PTNS for 12 weeks. Data from self-report OAB questionnaire short form (q-SF) and incontinence (I)-QoL questionnaires were collected pretreatment and at Weeks 6 and 12. Patients’ self-perceived benefits on symptoms (treatment benefit scale, TBS) were also gathered. Mean change in scores within and between groups were estimated. Results: Sixty-eight adult patients (67.6% women) were included in the intention to treat analysis. Of those, 61 completed all questionnaires and were analyzed as per protocol. Statistically significant improvements in OAB-q-SF and I-QoL between baseline and end-of-treatment scores were observed in both TTNS and PTNS groups (p <.001), being the differences much higher than the minimal important difference in both questionnaires. The scores of the OAB-q-SF scales (symptoms bother and health-related QoL) showed no statistically significant differences between the two groups. Similarly, the differences regarding the I-QoL questionnaire were statistically nonsignificant either (p =.607). When assessing the treatment benefit on symptoms, TBS responses between groups showed no statistical differences. Conclusion: A significant improvement of QoL was observed in both TTNS and PTNS groups. However, no patient-reported outcomes measures scores support a difference between the two groups. Therefore, these findings along with TTNS ease of application and less invasiveness may lead to an increased indication of this technique for OAB.