A prospective, single‐blind, randomized crossover trial of sacral vs pudendal nerve stimulation for interstitial cystitis

Abstract

To compare sacral nerve stimulation (SNS) with pudendal nerve stimulation (PNS) for interstitial cystitis (IC). Twenty-two patients with well-documented, refractory IC had a tined lead placed at S3 and a second electrode implanted at the pudendal nerve via a posterior approach. In a blinded, randomized design, each lead was tested for 7 days. The best lead was implanted to a pulse generator and patients were followed at 1, 3 and 6 months. The time required to place a sacral lead was 27.4 min, and a pudendal lead 19.6 min (P = 0.039). Of the 22 patients, 17 (77%) responded and had a permanent implant placed. PNS was chosen as the better lead in 77% and SNS in 24%. The order in which the lead was stimulated had no effect on the final lead implanted and there was no 'carry-over' effect. The overall reduction in symptoms was 59% for PNS and 44% for SNS (P = 0.05). At 6 months after implantation, voids improved by 41% (PNS) and 33% (SNS), and mean voided volume increased 95% and 21%, respectively; validated IC questionnaires improved markedly and complications were minimal. This is the first 'blinded' study of SNS vs PNS for IC. A pudendal lead was implanted successfully in all patients, and most chose PNS as better than SNS; the improvement was sustained over time.