Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women (NCT07458737) | Clinical Trial Compass
CompletedNot Applicable
Pelvic Floor Shear-Wave Elastography in Healthy and Pudendal Neuralgia Women
Slovakia94 participantsStarted 2025-03-15
Plain-language summary
This study will compare superficial pelvic floor shear-wave elastography between healthy women and women with pudendal neuralgia.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.