Initial experience using a novel nerve stimulator for the management of pudendal neuralgia

Abstract Aims In patients with pudendal neuralgia, prior studies have shown efficacy in chronic stimulation with Interstim® (Medtronic, Inc.). This feasibility study reports on the initial experience of using a wireless system to power an implanted lead at the pudendal nerve, StimWave®, to treat pudendal neuralgia. Methods Retrospective chart review identified patients with a lead placed at the pudendal nerve for neuralgia and powered wirelessly. Clinical outcomes were assessed at Postoperative visits and phone calls. Administered non‐validated follow‐up questionnaire evaluated the Global Response Assessment, percentage of pain improvement, satisfaction with device, and initial and current settings of the device (h/day of stimulation). Results Thirteen patients had the StimWave® lead placed at the pudendal nerve, 12 (92%) female and 1 (7.6%) male. Mean age was 50 years (range: 20–58). Failed prior therapies include medical therapy (100%), pelvic floor physical therapy (92%), pudendal nerve blocks (85%), pelvic floor muscle trigger point injections (69%), neuromodulation (30.7%), or surgeries for urogenital pain (23.1%). After the trial period, 10/13 (76.9%) had >50% improvement in pain with 6/13 (46.1%) reporting 100% pain improvement. Nine underwent permanent lead placement. At last postoperative visit (range, 6–83 days), 5/9 patients reported >50% pain improvement. Seven patients reached for phone calls (22–759 days) reported symptoms to be “markedly improved” ( n = 2), “moderately improved” ( n = 4), or “slightly improved” ( n = 1). At follow up, complications included lead migration ( n = 2), broken wire ( n = 1), or nonfunctioning antenna ( n = 2). Conclusion Complex patients with pudendal neuralgia may benefit from pudendal nerve stimulation via StimWave®.