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 range
18 Years
Sex
FEMALE
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.