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Introduction: Pudendal neuralgia is a chronic and debilitating condition with 10- 25% of patients refractory to traditional therapies including sacral neuromodulation. Prior studies have shown chronic pudendal nerve stimulation with Interstim® (Medtronic, Inc., Minneapolis, MN) is effective for this patient population. 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 pudendal neuralgia who had a lead placed at the pudendal nerve and powered wirelessly according to patient need. Clinical outcomes were assessed at post-operative visits as well as phone calls. Non-validated follow-up questionnaire were administered including the GRA, percentage of pain improvement, satisfaction with the device, the initial settings of the device at implantation, and the current settings (number of hours/day of stimulation). Results: Thirteen patients with pudendal neuralgia 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) with average BMI of 25.3 kg/m2. 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 went on to undergo permanent lead placement. At last post-operative follow-up (range 6-83 d), 4/9 patients reported 50% or greater pain improvement. Seven patients were reached for follow-up (8-734 d), reporting their 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 post-operative complications including lead migration (n=2), broken wire (n=1) or nonfunctioning antenna (n=2). Discussion: Complex patients with pudendal neuralgia refractory to traditional therapies may benefit from pudendal nerve stimulation via StimWave® neuromodulation.


The Annual Winter Meeting of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction, Virtual, February 25-27, 2021.

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