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

NCT07553715 | Not Yet Recruiting

• 1 other identifier: AP_LB_SG_shock
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvodynia

Outcome Measures

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.

  4 weeks (Week 4)

Secondary Outcomes (15)

• Therapeutic Success at 3 Months Based on PGIC

  12 weeks (Week 12)

• Pain Intensity During Treatment Sessions (VAS 0-100)

  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)

  Baseline and Week 4

• Change in Pressure Pain Threshold (Vulvagesiometer Measurement)

  Baseline (Week 0) and Week 4

• Change in Sexual Function (FSFI Total Score)

  Baseline and Week 4

Study Arms (1)

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

Interventions

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.

Women with Vulvodynia Treated With Focal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate (non-opposition not obtained)
• Inability to understand French language, preventing completion of study questionnaires

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lisa Bruckmann

CONTACT

+33 2 40 16 50 58; lisa.bruckmann@chu-nantes.fr

Alexandra Poinas, PhD

CONTACT

+33 2 53 48 28 57; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: April 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04