Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
研究概览
简要总结
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
详细描述
Using shear-wave elastography, this study will compare the superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, and superficial transverse perineal muscles) between healthy women and women with pudendal neuralgia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(Pudendal Neuralgia Group)
- •Diagnosis of Pudendal Neuralgia based on the Nantes diagnostic criteria (Labat et al., 2008), specifically:
- •Pain located in the anatomical territory of the pudendal nerve.
- •Pain worsened by sitting.
- •Pain that does not wake the patient at night.
- •No objective sensory loss on clinical examination.
- •Positive response to an anesthetic pudendal nerve block.
- •Duration of symptoms: Chronic pelvic pain persisting for more than 3 months.
- •Demographics: Women aged (≥18 years).
- •Voluntary participation: Ability to understand and sign informed consent.
- •Inclusion Criteria (Healthy Controls)
- •Demographics: Women aged (≥18 years).
- •Asymptomatic status: No history or current symptoms of chronic pelvic pain or pelvic floor dysfunction (confirmed by clinical interview/screening).
- •Voluntary participation: Signed informed consent.
排除标准
- •(Both Groups)
- •Medical Comorbidities: Diagnosed psychiatric, neurological (other than PN), severe internal, orthopedic, or oncological diseases that could interfere with the study outcomes.
- •Recent Interventions: History of botulinum toxin therapy to the pelvic floor within the last 12 months.
- •Pelvic surgery within the last 12 months.
- •Data Integrity: Incomplete or incorrectly filled questionnaires.
- •General: Unwillingness to participate or inability to provide informed consent.
研究组 & 干预措施
Healthy women
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
干预措施: Pelvic floor shear wave elastography (Diagnostic Test)
Healthy women
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
干预措施: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) (Diagnostic Test)
Women with Pudendal Neuralgia
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
干预措施: Female Sexual Distress Scale-Revised (FSDS-R) (Diagnostic Test)
Healthy women
Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.
干预措施: Female Sexual Distress Scale-Revised (FSDS-R) (Diagnostic Test)
Women with Pudendal Neuralgia
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
干预措施: Pelvic floor shear wave elastography (Diagnostic Test)
Women with Pudendal Neuralgia
Adult women (≥18 years) with chronic pelvic pain consistent with pudendal neuralgia . The diagnosis of pudendal neuralgia was confirmed by a gynecologist.
干预措施: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) (Diagnostic Test)
结局指标
主要结局
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
时间窗: Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.
Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia. Shell analysis was used to identify and compare two specific locations within each muscle: the site of maximum stiffness (b-site) and the site of minimum stiffness (a-site). The data represent the maximum stiffness measured at the most affected sites in KPa.
Superficial pelvic floor muscle stiffness (kPa) measured by shear-wave elastography
时间窗: Baseline (Day 1 after enrollment; single assessment)
Stiffness of superficial pelvic floor muscles (bulbospongiosus, ischiocavernosus, superficial transverse perineal muscles) assessed with SWE; comparison between healthy women and women with pudendal neuralgia.
次要结局
- Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)(Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.)
- Sexual Distress (FSDS-R Total Score)(Baseline (Day 1 after enrollment; single assessment) Participants underwent a single assessment on Day 1 after enrollment. Cross-sectional design: baseline and outcomes collected simultaneously.)
- Pelvic floor disorder impact on quality of life (PFIQ-7 total score and subscale scores)(Baseline (Day 1 after enrollment; single assessment))
- Sexual distress (FSDS-R total score)(Baseline (Day 1 after enrollment; single assessment))