NCT07458737

Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women

Comparison of Superficial Pelvic Floor Shear Wave Elastography Between Healthy Women and Women With Pudendal Neuralgia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 94 (actual)
• Sponsor: Comenius University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.

Detailed description

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.

Conditions

• Pudendal Nerve
• Healthy Women

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pelvic floor shear wave elastography	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).
DIAGNOSTIC_TEST	Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)	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.
DIAGNOSTIC_TEST	Female Sexual Distress Scale-Revised (FSDS-R)	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.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-02-25
• Completion: 2026-03-02
• First posted: 2026-03-09
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

1 site across 1 country: Slovakia