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Ultrasound study probes pelvic floor differences in nerve pain

NCT ID NCT07458737

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

94 people

The number who actually took part.

Started

Mar 2025

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Comenius University in Bratislava, Jessenius Faculty of Medicine , Martin, Slovakia

    Martin, Slovakia, 040 22, Slovakia

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