Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia (Shock-V)

Evaluation of the Effectiveness of a Four-Session Low-Intensity Focal Extracorporeal Shock Wave Therapy (LiSWT) Protocol in Women With Vulvodynia: A Retrospective Observational Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vulvodynia
• Intervention / Treatment: Device: Low-Intensity Focal Extracorporeal Shock Wave Therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Alexandra Poinas, PhD; Phone Number: +33 2 53 48 28 57; Email: alexandra.poinas@chu-nantes.fr
• Study Contact Backup: Name: Lisa Bruckmann; Phone Number: +33 2 40 16 50 58; Email: lisa.bruckmann@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women diagnosed with vulvodynia and treated with focal extracorporeal shock wave therapy in routine clinical practice at a university hospital in France.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with Vulvodynia Treated With Focal Shock Wave Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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).	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).	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).	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).	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.	From Week 1 through Week 16

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Vulvar Diseases; Vulvodynia
• Other Study ID Numbers: AP_LB_SG_shock

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No