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NCT Number: NCT07553715

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

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.

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Key information

Conditions

Vulvodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Intensity Focal Extracorporeal Shock Wave Therapy

Device

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.

Primary outcomes

  1. Therapeutic Success at 1 Month Based on PGIC

    Time frame: 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 outcomes

  1. Therapeutic Success at 3 Months Based on PGIC

    Time frame: 12 weeks (Week 12)

    Percentage of patients classified as therapeutic success (PGIC score 1 or 2) at 3 months after treatment.

  2. Pain Intensity During Treatment Sessions (VAS 0-100)

    Time frame: 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.

  3. Change in Average Vulvar Pain Over the Last 7 Days (VAS 0-100)

    Time frame: 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.

  4. Change in Pressure Pain Threshold (Vulvagesiometer Measurement)

    Time frame: 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.

  5. Change in Sexual Function (FSFI Total Score)

    Time frame: 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.

  6. Baseline Age (Years) as Predictor of Therapeutic Success

    Time frame: 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.

  7. Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success

    Time frame: 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).

  8. Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success

    Time frame: 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).

  9. Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success

    Time frame: 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).

  10. Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success

    Time frame: 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).

  11. Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success

    Time frame: 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).

  12. Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success

    Time frame: 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).

  13. Baseline Pain Catastrophizing Scale (PCS-CF) Score as Predictor of Therapeutic Success

    Time frame: 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).

  14. Baseline PTSD Checklist Scale (PCL-S) Score as Predictor of Therapeutic Success

    Time frame: 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).

  15. Adverse Events Related to Shock Wave Therapy

    Time frame: From Week 1 through Week 16

    Number and type of adverse events reported during treatment sessions and follow-up visits.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Lisa Bruckmann

CONTACT

[email protected]

+33 2 40 16 50 58

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: Shock-V

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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