Vulvodynia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELow-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.
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 years or older * Clinical diagnosis of vulvodynia * Received at least one session of low-intensity focal extracorporeal shock wave therapy in routine clinical practice
Exclusion criteria
* Refusal to participate (non-opposition not obtained) * Inability to understand French language, preventing completion of study questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Success at 1 Month Based on PGIC | 4 weeks (Week 4) | Percentage of patients classified as treatment "success" at 1 month follow-up according to the Patient Global Impression of Change (PGIC) scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Success at 3 Months Based on PGIC | 12 weeks (Week 12) | Percentage of patients classified as therapeutic success (PGIC score 1 or 2) at 3 months after treatment. |
| Pain Intensity During Treatment Sessions (VAS 0-100) | Baseline (pre-session) and immediately post-session at Weeks 1, 2, 3, and 4 | Change in pain intensity measured using a 0-100 mm Visual Analog Scale (VAS) recorded before and after each of the four treatment sessions. |
| Change in Average Vulvar Pain Over the Last 7 Days (VAS 0-100) | Baseline and Week 4 | 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. |
| Change in Pressure Pain Threshold (Vulvagesiometer Measurement) | Baseline (Week 0) and Week 4 | 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. |
| Change in Sexual Function (FSFI Total Score) | Baseline and Week 4 | 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. |
| Baseline Age (Years) as Predictor of Therapeutic Success | Baseline and Week 4 | 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. |
| Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success | Baseline and Week 4 | Duration of vulvar pain symptoms in months at baseline evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month). |
| Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success | Baseline and Week 4 | Presence of pelvic pain sensitization criteria at baseline (yes/no) evaluated as a predictor of therapeutic success (PGIC score 1-2 at 1 month). |
| Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Baseline Pain Catastrophizing Scale (PCS-CF) Score as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Baseline PTSD Checklist Scale (PCL-S) Score as Predictor of Therapeutic Success | Baseline and Week 4 | 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). |
| Adverse Events Related to Shock Wave Therapy | From Week 1 through Week 16 | Number and type of adverse events reported during treatment sessions and follow-up visits. |
Countries
France
Contacts
CONTACTLisa Bruckmann
CONTACTAlexandra Poinas, PhD
Outcome results
None listed