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Introduction: In patients with pudendal neuralgia refractory to traditional therapies, prior studies have shown efficacy in chronic stimulation with Interstim® (Medtronic, Inc., Minneapolis, MN). This study reports on 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 GRA, percentage of pain improvement, satisfaction with device, and initial and current settings of the device (hours/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 (PFPT) (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 post-operative visit (range 6-83 d), 4/9 patients reported >50% pain improvement. Seven patients reached for phone calls (8-734 d) reported symptoms to be "markedly improved" (n=2; 28.6%), "moderately improved" (n =4; 57.1%,), or "slightly improved" (n=1; 14.3%). Over half (5/7) reported complications including lead migration (n=2), broken wire (n=1) or non-functioning antenna (n=2). Conclusion: Complex patients with refractory pudendal neuralgia may benefit from pudendal nerve stimulation via StimWave®


The 95th Annual Meeting of the North Central Section of the AUA, Chicago, IL, October 6-9, 2021.

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