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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Nantes) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07553715 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
- Study coordinator: Lisa Bruckmann
- Email: lisa.bruckmann@chu-nantes.fr
- Phone: +33 2 40 16 50 58
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.
-
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.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.