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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Therapeutic Success at 1 Month Based on PGIC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal to participate (non-opposition not obtained)
- •Inability to understand French language, preventing completion of study questionnaires
研究组 & 干预措施
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.
干预措施: Low-Intensity Focal Extracorporeal Shock Wave Therapy (Device)
结局指标
主要结局
Therapeutic Success at 1 Month Based on PGIC
时间窗: 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.
次要结局
- 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)
- Baseline Age (Years) as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Duration of Vulvar Pain (Months) as Predictor of Therapeutic Success(Baseline and Week 4)
- Presence of Chronic Overlapping Pain Conditions as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Pelvic Pain Sensitization Criteria as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Myofascial Perineal Syndromes as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Beck Anxiety Inventory (BAI) Score as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Beck Depression Inventory (BDI) Score as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline Pain Catastrophizing Scale (PCS-CF) Score as Predictor of Therapeutic Success(Baseline and Week 4)
- Baseline PTSD Checklist Scale (PCL-S) Score as Predictor of Therapeutic Success(Baseline and Week 4)
- Adverse Events Related to Shock Wave Therapy(From Week 1 through Week 16)