Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study.
| Title: | Spinal-Cord Stimulation for Intractable, Visceral Pain Associated With Endometriosis: Positive Results of a Feasibility Study. |
|---|---|
| Authors: | van Haaps AP; Department of Reproductive Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, The Netherlands. Electronic address: a.vanhaaps@amsterdamumc.nl.; Kallewaard JW; Department of Anesthesiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Department of Anesthesiology, Rijnstate Ziekenhuis, Arnhem, The Netherlands.; Bieze M; Department of Anesthesiology and Pain Management, Erasmus MI, University Medical Center Rotterdam, Rotterdam, The Netherlands.; Erwteman M; Department of Anesthesiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.; Nap A; Department of Gynaecology and Obstetrics, Radboud University Medical Center, Nijmegen, The Netherlands.; Hollmann MW; Department of Anesthesiology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.; Schreurs AMF; Department of Reproductive Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, The Netherlands.; Mijatovic V; Department of Reproductive Medicine, Amsterdam University Medical Centers, Amsterdam, The Netherlands; Amsterdam Reproduction and Development, Amsterdam University Medical Centers, Amsterdam, The Netherlands. |
| Source: | Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2025 Dec 03. Date of Electronic Publication: 2025 Dec 03. |
| Publication Model: | Ahead of Print |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: United States NLM ID: 9804159 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1525-1403 (Electronic) Linking ISSN: 10947159 NLM ISO Abbreviation: Neuromodulation Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2022- : [New York] : Elsevier; Original Publication: Malden, MA : Blackwell Science, c1998- |
| Abstract: | Objectives: Endometriosis, an estrogen-dependent chronic inflammatory disease, can cause visceral pain. Owing to its chronic nature, treatment can be challenging and insufficient in reducing all symptoms despite adequate management. Spinal-cord stimulation (SCS), a well-established treatment, could be used in treating intractable, endometriosis-related visceral pain and thereby improve quality of life (QoL).; Materials and Methods: A prospective, unblinded feasibility study (NCT05558540) was conducted between May 2022 and January 2025. We included patients with endometriosis reporting pain scores ≥ 5 (numeric rating scale [NRS], 0-10) who are experiencing dysmenorrhea, dyspareunia, and/or chronic pelvic pain (CPP), with a clear neurologic examination and approval for SCS during multidisciplinary consultation. All participants received a Boston device with two 16-contact Infinion CX leads placed between T8 and T12, with a 14-day trial period before permanent implantation. Inclusion stopped when seven participants experienced ≥ 50% symptom improvement at 6-month follow-up. Pain symptom reduction (in NRS) was used as the primary outcome. Secondary outcomes included change in QoL (NRS; Endometriosis Health Profile-30 [EHP-30]), Short Fatigue Questionnaire, Pain Catastrophizing Scale, and analgesic use. Data were collected through questionnaires and during examination visits.; Results: Nine participants underwent SCS, and after a successful trial period, all had a permanent implantation. Improvement in general and worst pain, and of dysmenorrhea, CPP, dysuria, and dyschezia was observed when comparing baseline with different follow-up moments. Improvement was found in self-reported QoL scores and in all but one of the EHP-30 core domains. All participants but one were able to reduce their analgesics. One participant underwent device explantation owing to lack of effect at 12-month follow-up.; Conclusions: SCS reduced intractable, endometriosis-related visceral pain and improved QoL. Because no sample size calculation could be performed, the results should be interpreted with caution. We emphasize the need to further study the application of SCS for endometriosis by performing randomized studies, which also includes a cost-analysis.; Clinical Trial Registration: The Clinicaltrials.gov registration number for the study is NCT05558540.; (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.) |
| Competing Interests: | Conflict of Interest Annelotte P. van Haaps reports receiving speaking fees from Boston Scientific. Jan Willem Kallewaard reports serving on advisory boards for Boston Scientific, Saluda Medical, and Medtronic. The remaining authors reported no conflict of interest. |
| Contributed Indexing: | Keywords: Endometriosis; pain symptoms; quality of life; spinal-cord stimulation |
| Molecular Sequence: | ClinicalTrials.gov NCT05558540 |
| Entry Date(s): | Date Created: 20251203 Latest Revision: 20251209 |
| Update Code: | 20260130 |
| DOI: | 10.1016/j.neurom.2025.10.067 |
| PMID: | 41335088 |
| Database: | MEDLINE |
Journal Article