Ultrasound study probes pelvic floor differences in nerve pain
NCT ID NCT07458737
First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This study used a special ultrasound technique to measure stiffness in pelvic floor muscles of 94 women — some healthy and some with pudendal neuralgia, a chronic nerve pain condition. Researchers compared the muscle stiffness between the two groups to see if differences exist. The goal was to better understand the condition, not to test a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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94 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia
Martin, Slovakia, 040 22, Slovakia
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