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

Abstract

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 followup 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®.

Current role of neuromodulation in bladder pain syndrome/interstitial cystitis

“…Although most case series report the results with the percutaneous implantation of tined leads, there are also descriptions of open and laparoscopic lead placement, 30 , 31 and with implantable devices. 32 Little evidence supports the management of BPS/IC with pudendal-only neuromodulation; thus, a review of chronic pelvic-perineal pain syndromes was undergone.…”

“…Recently, the group by Hoang Roberts et al 32 reported the effectiveness of Stimwave ® Freedom Stimulators™ (Stimwave, Pompano Beach, FL, USA) in the management of pudendal neuralgia.…”

“…Table 2 summarizes the reports of different case series focused on chronic pudendal nerve stimulation in pelvic pain disorders. 30 – 32 , 36 , 37 , 42 – 45 …”

“…40 In another pilot study, 16 patients underwent both nerve release and implantation of a PNE lead through a posterior approach with full visual control. 41 Recently, the group by Hoang Roberts et al 32 reported the effectiveness of Stimwave ® Freedom Stimulators™ (Stimwave, Pompano Beach, FL, USA) in the management of pudendal neuralgia.…”

Pudendal, but not tibial, nerve stimulation modulates vulvar blood perfusion in anesthetized rodents

“…We hypothesized that a similar spinal reflex exists for genital vasocongestion. Both pudendal and tibial nerve stimulation have the potential to improve sexual function and have specific translational advantages, including the ease of access and existing clinical use for pelvic dysfunctions 18,19,26,30 , however a greater understanding of the underlying mechanisms and neural circuitry is needed.…”