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

NCT07458737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 94

Last updated 2026-04-02

Study results available
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Summary

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

Conditions

  • Pudendal Nerve
  • Healthy Women

Interventions

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.

Sponsors & Collaborators

  • Pavol Jozef Safarik University

    collaborator OTHER

  • Comenius University

    lead OTHER

Principal Investigators

  • Magdalena Hagovska, prof.PhDr.PhD. · Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia

  • Jan Svihra, prof.MUDr.PhD. · Comenius University Bratislava, Jessenius Faculty of Medicine in Martin, Slovakia

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2026-02-25
Completion
2026-03-02

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07458737 on ClinicalTrials.gov