Идёт набор NCT07553715

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

— Наблюдательное Vulvodynia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Low-Intensity Focal Extracorporeal Shock Wave Therapy.
Кому может быть актуально: Состояния в реестре: Vulvodynia. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Устройство Low-Intensity Focal Extracorporeal Shock Wave Therapy
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.

Первичные конечные точки

Therapeutic Success at 1 Month Based on PGIC [Срок оценки: 4 weeks (Week 4)]

Вторичные конечные точки (12)

Therapeutic Success at 3 Months Based on PGIC [Срок оценки: 12 weeks (Week 12)]
Pain Intensity During Treatment Sessions (VAS 0-100) [Срок оценки: 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) [Срок оценки: Baseline and Week 4]
Change in Pressure Pain Threshold (Vulvagesiometer Measurement) [Срок оценки: Baseline (Week 0) and Week 4]
Change in Sexual Function (FSFI Total Score) [Срок оценки: Baseline and Week 4]
Baseline Age (Years) as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]
Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success [Срок оценки: Baseline and Week 4]

Критерии участия

Критерии включения

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