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

NCT07458737 | Completed Results

• 1 other identifier: 6808/2023/ODDZ
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pudendal Nerve; Healthy Women

Keywords

Pudendal neuralgia, Shear-wave elastography, Healthy women

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Secondary Outcomes (2)

• 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.

Study Arms (2)

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.

Diagnostic Test: Pelvic floor shear wave elastography; Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)

Healthy women

Healthy women (≥18 years) with no history of chronic pelvic pain or pelvic floor dysfunction.

Diagnostic Test: Pelvic floor shear wave elastography; Diagnostic Test: Pelvic Floor Impact Questionnaire-Short Form 7 (PFIQ-7); Diagnostic Test: Female Sexual Distress Scale-Revised (FSDS-R)

Interventions

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).

Healthy women; Women with Pudendal Neuralgia

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.

Healthy women; Women with Pudendal Neuralgia

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.

Healthy women; Women with Pudendal Neuralgia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population This observational study enrolled adult women (≥18 years) categorized into two cohorts: a pudendal neuralgia (PN) group and a healthy control group. Participants in the PN group were recruited from an outpatient clinic database. Inclusion required a diagnosis of pudendal neuralgia confirmed by a gynecologist according to the Nantes criteria (Labat et al., 2008), including a positive response to an anesthetic pudendal nerve block, and a symptom duration of ≥ 3 months. The healthy control group consisted of volunteers recruited from university staff with no history of chronic pelvic pain or pelvic floor dysfunction.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Comenius University: lead
• Pavol Jozef Safarik University: collaborator

Study Sites (1)

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

Martin, Slovakia, 040 22, Slovakia

Location

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jan Svihra prof.MD. PhD.
• Organization: Jessenius Faculty of Medicine Commenius University Bratislava Slovakia

jan.svihra@uniba.sk

+421905369155

Study Officials

• Magdalena Hagovska, prof.PhDr.PhD.

  Pavol Jozef Safarik University, Medical Faculty, Kosice Slovakia

  PRINCIPAL INVESTIGATOR

• Jan Svihra, prof.MUDr.PhD.

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 9, 2026
• Study Start: March 15, 2025
• Primary Completion: February 25, 2026
• Study Completion: March 2, 2026
• Last Updated: July 6, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-06

Locations

SL (1)