N/A
Completed N=88
Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women
Pudendal Nerve · Healthy Women
Source: ClinicalTrials.gov NCT07458737 ↗
Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Superficial Pelvic Floor Muscle (Bulbospongiosus, Ischiocavernosus, Superficial Transverse Perineal Muscles)Stiffness (kPa) Measured by Shear-wave Elastography — 612; 26.5; 324.5; 120 kilopascals
Summary
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
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 | — |
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. Informational only — not medical advice.