Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

Four-session focal shock wave therapy for vulvodynia in women

Official 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

Run by Nantes University Hospital · NCT07553715 · Data updated 2026-11-12

This study looks at whether four weekly sessions of low-intensity focal shock wave therapy help women with vulvodynia in real-life clinical practice.

More Vulvodynia trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment50 (estimated)
SponsorNantes University Hospital
Academic / other
Locations1 site (Nantes, Nantes)
StatusRecruiting
StartedApril 1, 2026
Main results expectedDecember 1, 2026
Study endsDecember 1, 2026
Registry record updatedJune 24, 2026
Trial IDNCT07553715 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18 or older with vulvodynia who received at least one session of low-intensity focal shock wave therapy in routine care at the Nantes University Hospital.

Probably not a fit

Results may show no meaningful improvement for some patients or identify subgroups less likely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center retrospective study at a French university hospital. It analyzes medical records and patient-reported outcomes from women who received a standardized four-session therapy using a focal shock wave device. The aim is to see how symptoms and function change after treatment in routine care, without altering patient management. Data are pseudonymized and analyzed to describe real-world effectiveness and guide future research. No new interventions are introduced as part of the study.

Why it matters

Potential benefit: If effective, the approach could provide a non-invasive option to reduce pain and improve daily functioning for vulvodynia.

How similar studies have gone: Real-world data on this specific four-session protocol in vulvodynia are limited, with some prior reports suggesting potential benefit but needing confirmation.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • CHU Nantes- Allergy Department
    Nantes, Nantes, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Topical ketotifen 0.25% for secondary vestibulodynia

    This Phase 2 trial will test whether applying ketotifen 0.25% cream to the vulvar vestibule reduces pain in adult women with secondary provoked vestibulodynia.

    Recruiting at 3 sites Phase 2 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 2 other locations · NCT07257029

  • Improving diagnosis of vestibulodynia using omics approaches

    This study is trying to find better ways to diagnose vestibulodynia in women aged 18 to 50 by looking at biological samples to see if there are specific markers that can help identify this painful condition.

    Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Pavia · NCT06865963

  • Interventions for managing pelvic health issues in women

    This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.

    Recruiting at 2 sites University of Ottawa · Ottawa, Ontario and 1 other locations · NCT06660212

  • Testing low-dose naltrexone for vulvodynia pain relief

    This study is testing if low-dose naltrexone can help women with vulvodynia feel less pain and improve their quality of life.

    Recruiting Phase 2 Medical University of Lublin · Lublin · NCT05955313

  • Creating a data bank to study vaginal conditions

    This study is trying to understand how certain proteins and germs in the vagina might be linked to conditions like vulvodynia and recurrent infections by comparing women who have symptoms to those who don’t.

    Recruiting Texas Tech University Health Sciences Center · Midland, Texas · NCT01829204

  • 12-week online pelvic health program for provoked vestibulodynia

    This project will try a 12-week online pelvic health program to see if it reduces pain and improves sexual wellbeing for adults in North America with provoked vestibulodynia.

    Recruiting Queen's University · Kingston, Ontario · NCT06999395

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.