This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
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.
Study Type
OBSERVATIONAL
Enrollment
94
Imaging was performed using a Consona N8 ultrasound system (Shenzhen Mindray Bio-Medical Electronics Co., Ltd.) equipped with shear-wave elastography (SWE) software. A linear-array transducer (L13-3N; frequency range 3.0-13.0 MHz; field of view \~3.8-4.0 cm) was used to obtain pelvic floor muscle (PFM) images. Measurements were performed using shell analysis by comparing two locations within the same pelvic floor muscle: the sites with the highest and lowest stiffness (kPa).
The PFIQ-7 is a 21-item questionnaire (three scales with seven items each) assessing the impact of pelvic floor disorders on daily life. Items are scored from 0 to 3, and the total score ranges from 0 to 300. Higher scores indicate greater impact/distress.
Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia
Martin, Slovakia, Slovakia
Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography
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.
Time frame: 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)
The Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7) is a 21-item instrument that assesses the impact of pelvic floor disorders across three domains: bladder (Urinary Impact Questionnaire, UIQ-7), bowel (Colorectal-Anal Impact Questionnaire, CRAIQ-7), and vaginal symptoms (Pelvic Organ Prolapse Impact Questionnaire, POPIQ-7). Scale Ranges: Each of the three subscales (UIQ-7, CRAIQ-7, and POPIQ-7) is scored from 0 to 100. The PFIQ-7 Total Score is calculated as the sum of these three subscales, ranging from a minimum of 0 to a maximum of 300. Interpretation: For all subscales and the total score, higher values represent a worse outcome (greater negative impact on quality of life).
Time frame: 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)
Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.
Time frame: 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.
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The FSDS-R is a 13-item questionnaire assessing sexually related personal distress in women, with a total score range of 0-52. Items are rated on a 5-point Likert scale (0 = never to 4 = always). Higher scores indicate greater sexual distress.