VulvodyniaShock-VNCT07553715
Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia
An observational study of Vulvodynia, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Low-Intensity Focal Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with vulvodynia and treated with focal extracorporeal shock wave therapy in routine clinical practice at a university hospital in France.
Who may be able to join
- 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
Who cannot join
- Refusal to participate (non-opposition not obtained)
- Inability to understand French language, preventing completion of study questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes- Allergy Department
Nantes, Nantes, 44000
Alexandra Poinas, +33 2 40 08 33 33, alexandra.poinas@chu-nantes.fr
About this study
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
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.
Read the 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.
- Conditions
- Vulvodynia
- Being tested
- Low-Intensity Focal Extracorporeal Shock Wave Therapy
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Intensity Focal Extracorporeal Shock Wave TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low-Intensity Focal Extracorporeal Shock Wave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks (Week 4)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: From Week 1 through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553715
- Sponsor's protocol ID
- AP_LB_SG_shock
- Acronym
- Shock-V
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07553715
- Acronym / sponsor ID
- Shock-V / AP_LB_SG_shock
- Conditions
- Vulvodynia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with Vulvodynia Treated With Focal Shock Wave Therapy | – | Device: Low-Intensity Focal Extracorporeal Shock Wave TherapyWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with vulvodynia and treated with focal extracorporeal shock wave therapy in routine clinical practice at a university hospital in France.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal to participate (non-opposition not obtained)
- Inability to understand French language, preventing completion of study questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Intensity Focal Extracorporeal Shock Wave TherapyLow-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. | Device | Women with Vulvodynia Treated With Focal Shock Wave Therapy |
Primary outcome
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.
15 secondary outcomes
Therapeutic Success at 3 Months Based on PGIC
Time frame: 12 weeks (Week 12)
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 Average Vulvar Pain Over the Last 7 Days (VAS 0-100)
Time frame: Baseline and Week 4
Change in Pressure Pain Threshold (Vulvagesiometer Measurement)
Time frame: Baseline (Week 0) and Week 4
Change in Sexual Function (FSFI Total Score)
Time frame: Baseline and Week 4
Baseline Age (Years) as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline Pain Catastrophizing Scale (PCS-CF) Score as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Baseline PTSD Checklist Scale (PCL-S) Score as Predictor of Therapeutic Success
Time frame: Baseline and Week 4
Adverse Events Related to Shock Wave Therapy
Time frame: From Week 1 through Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Bruckmann (+33 2 40 16 50 58, lisa.bruckmann@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Success at 1 Month Based on PGIC (time frame: 4 weeks (Week 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.