N/A
N=88
Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women
Pudendal Nerve · Healthy Women
Bottom Line
View on ClinicalTrials.gov: NCT07458737 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography — 612; 26.5; 324.5; 120 kilopascals
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Comenius University
- Primary completion
- Feb 2026
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography |
612; 26.5; 324.5; 120; 451.5; 29.0 | — |
| SECONDARY Pelvic Floor Disorder Impact on Quality of Life (PFIQ-7 Total Score and Subscale Scores) |
200; 0 | — |
| SECONDARY Sexual Distress (FSDS-R Total Score) |
52; 0 | — |
Summary
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT07458737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.