Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia
ConditionVulvodynia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Refusal to participate (non-opposition not obtained)
Inability to understand French language, preventing completion of study questionnaires
Trial population
Women diagnosed with vulvodynia and treated with focal extracorporeal shock wave therapy in routine clinical practice at a university hospital in France.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Low-Intensity Focal Extracorporeal Shock Wave Therapy
DeviceLow-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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Women with Vulvodynia Treated With Focal Shock Wave Therapy1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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 43
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 44
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 4Sponsors and contacts
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Source ClinicalTrials.gov