Actively Recruiting
Retrospective Study on Low-Intensity Focal Shock Wave Therapy in Women with Vulvodynia Evaluating Four Weekly Treatment Sessions at a University Hospital
Led by Nantes University Hospital · Updated on 2026-06-24
50
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a four-session low-intensity focal extracorporeal shock wave therapy protocol in women diagnosed with vulvodynia, a chronic vulvar pain condition that can significantly impact quality of life. The study is retrospective and observational, analyzing data collected during routine clinical care at a university hospital in France to better understand real-world treatment outcomes. Women included in the study received four weekly sessions of low-intensity focal extracorporeal shock wave therapy delivered by a medical device called Duolith SD1 from Storz Medical. This therapy was provided as part of standard care, with no additional interventions assigned for the study. The study collects data from medical records and patient questionnaires completed during routine follow-up visits. Participants clinical progress and questionnaire responses are analyzed to assess changes in pain intensity, functional outcomes, sexual function, and other related measures before and after treatment. The primary outcome is therapeutic success at 1 month based on patient global impression of change. Safety data are also reviewed up to 16 weeks. The study uses pseudonymized data following European privacy regulations and aims to inform future prospective research. The total participation timeline varies as data are collected retrospectively.
CONDITIONS
Brief Title
Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia
Research Team
L
Lisa Bruckmann
A
Alexandra Poinas, PhD
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