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Indirect Non-invasive Evaluation of Pudendal Neuropathy

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ClinicalTrials.gov Identifier: NCT03933683
Recruitment Status : Active, not recruiting
First Posted : May 1, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Luigi Brusciano, University of Campania "Luigi Vanvitelli"

Brief 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.


Condition or disease Intervention/treatment
Fecal Incontinence Device: Pudendal nerve terminal motor latency assessment

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Study Type : Observational [Patient Registry]
Actual Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Indirect Non-invasive Evaluation of Pudendal Neuropathy by Dynamic Transperineal Ultrasound in Patients With Pelvic Floor Dysfunction
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : March 1, 2019
Estimated Study Completion Date : February 15, 2022


Group/Cohort Intervention/treatment
Pathologic Group
Patients affected by Fecal Incontinence
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.
Other Name: Dynamic transperineal Ultrasound

Control Group
Healty volunteers cohort
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.
Other Name: Dynamic transperineal Ultrasound




Primary Outcome Measures :
  1. Concordance between pudendal nerve motor latency and dynamic transperineal ultrasound for the evaluation of pudendal neuropathy [ Time Frame: 3 months ]
    Concordanace between pudendal nerve terminal motor latency (the actual gold standard in the evaluation of pudendal neuropathy, expressed in ms) and puborectalis displacement (expressed in mm) analysed by dynamic transperineal ultrasound for the evaluation of pudendal neuropathy in gruop of patients affected by fecal incontince. The data will be compared to the results obtained in a cohort of healty volunteers



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients affected by fecal incontinence (FI) or urinary incontinence to our referral center of coloproctology (master of pelvi-perineal rehabilitation and master of coloproctology) at University of Study of Campania "Luigi Vanvitelli" of Naples were prospectively assessed.
Criteria

Inclusion Criteria:

  • age ≥16
  • symptoms of faecal incontinence

Exclusion Criteria:

  • past history of anorectal or vaginal surgery
  • history of pelvic radiation or tumors -inability to complete the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933683


Locations
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Italy
University of Campania "Luigi Vanvitelli"
Napoli, Italy, 80131
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Principal Investigator: Luigi Brusciano, Prof University of Campania "Luigi Vanvitelli"

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Responsible Party: Luigi Brusciano, Clinical Professor, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03933683     History of Changes
Other Study ID Numbers: 229/19
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Luigi Brusciano, University of Campania "Luigi Vanvitelli":
fecal incontinence
pudendal neuropthy
pudendal nerve terminal motor latency

Additional relevant MeSH terms:
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Nerve Compression Syndromes
Fecal Incontinence
Pudendal Neuralgia
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms