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Indirect Non-invasive Evaluation of Pudendal Neuropathy

NCT03933683 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2019-05-02

No results posted yet for this study

Summary

Purpose: Pelvic floor is a complex anatomical entity and its neuromuscular assessment is evaluated through electromyography, evoked potentials and pudendal nerve terminal motor latency. An innovative approach is the study of pelvic floor through dynamic transperineal ultrasound (DTU). The aim of this study is to evaluate if anterior and posterior displacement of puborectalis muscle, studied by DTU, is a feasible and effective method to diagnose pudendal neuropathy alternatively to conventional St. Marks' glove.

Methods:Patients affected by fecal incontinence (FI) addressed to our referral center of coloproctology at University of Campania were prospectively assessed. After a specialized coloproctology evaluation, each patient with pelviperineal dysfunction was addressed to DTU to determine anterior and posterior displacement of puborectalis muscle, and subsequently a blinded neurophysiologist performed pudendal nerve terminal motor latency assessment to identify pudendal neuropathy. In order to compare the data, a cohort of 34 healthy volunteers was enrolled.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Pudendal nerve terminal motor latency assessment

After a specialized coloproctology evaluation, each patient with pelviperineal dysfunction was addressed to dynamic transperineal ultrasound to determine anterior and posterior displacement of puborectalis muscle, and subsequently a blinded neurophysiologist performed pudendal nerve terminal motor latency assessment to identify pudendal neuropathy.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Principal Investigators

  • Luigi Brusciano, Prof · University of Campania Luigi Vanvitelli

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-03-01
Completion
2022-02-15
FDA Device
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03933683 on ClinicalTrials.gov