Low-Intensity Shockwave for Treatment of Vestibulodynia: A Randomized Controlled Therapy Trial

Background: Provoked vestibulodynia (PVD) is an exhausting pain syndrome that immensely affects quality of sexual life and consequently negatively affects quality of life. Low-intensity shock wave therapy produces physical forces that lead to pain relief. Aim: The aim of this study was to evaluate the feasibility, safety, and efficacy of low-intensity shockwave therapy in patients with provoked vestibulodynia. Methods: This is a double-blinded, randomized, sham-controlled, prospective study of 32 women. The treatment protocol included a series of treatments, performed twice a week for 6 weeks. Each treatment consisted of 500 pulses of low intensity shockwaves (0.09 mJmm2) using the Medispec, ED-1000 shockwave generator or sham. Participants were assessed at the baseline, and at 1 and 3 months after completing all treatments. Outcomes: Pain was assessed by both subjective and objective measures. The primary outcome was a change in dyspareunia, as assessed by scores on the 10-point visual analog scale. Secondary outcome measures were changes in pain threshold and tolerance, assessed by a quantitative validated algometer test, the Wong-Baker pain FACES scale, the Female Sexual Function Index and the Patients' Global Impression of Change scale. Results: From the baseline to 1 month and 3 months after completion of treatment, visual analog scale scores for dyspareunia decreased (8.0 +/- 1.4, 5.7 +/- 2.3, and 4.4 +/- 2.5, respectively, P < .005). For these respective time points, Wong-Baker scores decreased (4.0 +/- 0.6, 2.9 +/- 1.2, 2.5 +/- 1.3, respectively, P < .05); and total Female Sexual Function Index increased (17.9 +/- 6.3, 20.9 +/- 6.2, 22.5 +/- 8, respectively, P < .002). Pain threshold and tolerance measured by the algometer were increased 3 months after completion of the treatment compared with the baseline (69.8 +/- 11.8 vs 22.9 +/- 9.0, P < .01 and 87.7 +/- 35.7 vs 43.3 +/- 14.7, P < .0001, respectively). No changes were observed in any of the measures assessed in the sham group. Clinical Implications: We found a new effective treatment for alleviating the most bothersome symptom in PVD, pain during penetration and intercourse. This resulted in improved sexual function. Strengths & Limitations: The strengths of this study are the randomized controlled design, the correlated subjective questionnaires, and the use of semiquantitative algometer methodology. The limitations are the relative low number of participants in a single center. Conclusion: For women with PVD, low-intensity shockwave therapy applied at the introitus is a feasible, safe, and effective treatment option that may have a beneficial effect in pain relief and in sexual function. Copyright (C) 2020, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.