Skip to main content
OpenTrials
Completed

NCT Number: NCT07458737

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pudendal Nerve Healthy Women Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pudendal Neuralgia Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia

Martin, Slovakia, 040 22

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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.

Exclusion criteria

(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.

Treatment and study plan

Pelvic floor shear wave elastography

Diagnostic Test

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).

Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7)

Diagnostic Test

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.

Female Sexual Distress Scale-Revised (FSDS-R)

Diagnostic Test

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.

Primary outcomes

  1. Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography

    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.

    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.

Secondary outcomes

  1. Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores)

    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.

    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).

  2. Sexual Distress (FSDS-R Total Score)

    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.

    Female Sexual Distress Scale-Revised (FSDS-R) total score (0-52). Higher scores indicate greater sexual distress.

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Collaborators

  • Pavol Jozef Safarik University

Registry information

Official study title

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

Acronym: ELANEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.