An observational study in Vulvodynia, sponsored by Nantes University Hospital. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Nantes University Hospital · Observational
Vulvodynia is a chronic vulvar pain condition that can significantly affect quality of life. Low-intensity focal extracorporeal shock wave therapy has been proposed as a non-invasive therapeutic option, but real-world data remain limited.
This retrospective observational study aims to evaluate the effectiveness of a four-session focal shock wave therapy protocol in women with vulvodynia treated in routine clinical practice at a university hospital. Clinical data collected during standard care, as well as questionnaire responses, will be analyzed to assess changes in symptoms and functional outcomes following treatment.
This is a single-center retrospective observational study conducted at a university hospital in France. The study is based on existing medical records of women diagnosed with vulvodynia who received a standardized protocol of four weekly sessions of low-intensity focal extracorporeal shock wave therapy using a medical device (Storz Medical Duolith SD1) as part of routine care.
The objective of the study is to evaluate the effectiveness of this therapeutic protocol in real-life conditions. Data collected during routine follow-up visits and through patient-reported outcome questionnaires will be analyzed. No additional intervention is assigned as part of the study, and patient management is not modified.
The study relies on pseudonymized clinical data extracted from medical records. Data processing complies with applicable European data protection regulations. Statistical analyses will primarily assess changes in clinical and patient-reported outcomes before and after treatment.
This study aims to generate real-world evidence to better characterize the clinical impact of focal shock wave therapy in women with vulvodynia and to inform future prospective research.
117 studies on the registry are indexed under Vulvodynia; 21 are open to participants now.
This study's planned enrollment of 50 is below the median of 168 across 25 observational studies indexed under Vulvodynia.
Browse Vulvodynia studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Women diagnosed with vulvodynia and treated with focal extracorporeal shock wave therapy in routine clinical practice at a university hospital in France.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women diagnosed with vulvodynia who received a standardized four-session protocol of low-intensity focal extracorporeal shock wave therapy as part of routine clinical care at a university hospital. Data are collected retrospectively from medical records.
Device: Low-Intensity Focal Extracorporeal Shock Wave Therapy
Low-intensity focal extracorporeal shock wave therapy delivered using a medical device (Duolith SD1, Storz Medical). The protocol consisted of four treatment sessions performed in routine clinical practice, typically at weekly intervals. Treatment parameters followed standard clinical settings used for vulvodynia management.
Therapeutic Success at 1 Month Based on PGIC
Percentage of patients classified as treatment "success" at 1 month follow-up according to the Patient Global Impression of Change (PGIC) scale.
Time frame: 4 weeks (Week 4)
Therapeutic Success at 3 Months Based on PGIC
Percentage of patients classified as therapeutic success (PGIC score 1 or 2) at 3 months after treatment.
Time frame: 12 weeks (Week 12)
Pain Intensity During Treatment Sessions (VAS 0-100)
Change in pain intensity measured using a 0-100 mm Visual Analog Scale (VAS) recorded before and after each of the four treatment sessions.
Time frame: Baseline (pre-session) and immediately post-session at Weeks 1, 2, 3, and 4
Change in Average Vulvar Pain Over the Last 7 Days (VAS 0-100)
Change in mean vulvar pain intensity over the previous 7 days, measured using a 0-100 mm Visual Analog Scale, comparing baseline consultation and post-treatment consultation.
Time frame: Baseline and Week 4
Change in Pressure Pain Threshold (Vulvagesiometer Measurement)
Change in vulvar pressure pain threshold measured using a vulvagesiometer before the first session and after completion of the four treatment sessions. Intra-patient mean correlation will be assessed.
Time frame: Baseline (Week 0) and Week 4
Change in Sexual Function (FSFI Total Score)
Change in Female Sexual Function Index (FSFI) total score. The FSFI is a validated 19-item questionnaire assessing desire, arousal, lubrication, orgasm, satisfaction, and pain. Total score ranges from 2 to 36, with higher scores indicating better sexual function.
Time frame: Baseline and Week 4
Baseline Age (Years) as Predictor of Therapeutic Success
Age in years at baseline evaluated as a predictor of therapeutic success, defined as Patient Global Impression of Change (PGIC) score 1 or 2 at 1 month.
Time frame: Baseline and Week 4
Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success
Duration of vulvar pain symptoms in months at baseline evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success
Presence or absence of chronic overlapping pain conditions (binary variable: yes/no) at baseline evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success
Presence of pelvic pain sensitization criteria at baseline (yes/no) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success
Presence of clinically assessed myofascial perineal syndromes at baseline (yes/no) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success
Baseline Beck Anxiety Inventory (BAI) total score (range 0-63; higher scores indicate greater anxiety severity) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success
Baseline Beck Depression Inventory (BDI) total score (range 0-63; higher scores indicate greater depressive symptom severity) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline Pain Catastrophizing Scale (PCS-CF) Score as Predictor of Therapeutic Success
Baseline Pain Catastrophizing Scale (PCS-CF) total score (range 0-52; higher scores indicate greater catastrophizing) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Baseline PTSD Checklist Scale (PCL-S) Score as Predictor of Therapeutic Success
Baseline PTSD Checklist Scale (PCL-S) total score (range 17-85; higher scores indicate greater post-traumatic stress symptom severity) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month).
Time frame: Baseline and Week 4
Adverse Events Related to Shock Wave Therapy
Number and type of adverse events reported during treatment sessions and follow-up visits.
Time frame: From Week 1 through Week 16
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