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Fecal IncontinenceNCT03933683

Indirect Non-invasive Evaluation of Pudendal Neuropathy

An observational study of Fecal Incontinence, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Fecal Incontinence
What is being tested?
Pudendal nerve terminal motor latency assessment
Type of treatment
Medical device
How many people
68 participants
Where
1 siteItaly
Study dates
1 Jan 2019to 15 Feb 2022
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • age ≥16
  • symptoms of faecal incontinence

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • University of Campania "Luigi Vanvitelli"

    Naples, 80131

Other trials in Italy

About this study

Official title: Indirect Non-invasive Evaluation of Pudendal Neuropathy by Dynamic Transperineal Ultrasound in Patients With Pelvic Floor Dysfunction

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.

Read the detailed description

This study is reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for cohort studies. Between January 2008 and December 2016, female patients affected by fecal incontinence (FI) or urinary incontinence referred 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. Inclusion criteria were age ≥16 and symptoms of faecal incontinence or constipation. Exclusion criteria were past history of anorectal or vaginal surgery, history of pelvic radiation or tumors and inability to complete the study protocol. Patients with pelviperineal dysfunction were enrolled in the study (Group A). Clinical symptoms were graded as follows: constipation was evaluated according to the Wexner Scale (0-30), continence was evaluated according to Cleveland Clinic incontinence score (0-20)13-14. The following information were collected: age, symptoms, grading, previous pelvic surgery. In order to compare and analyse the data, a cohort of 34 healthy volunteers was enrolled among students and residents of University of Campania "Luigi Vanvitelli" (Group B). The local ethical committee approved the study protocol.

Patients All patients were assessed during a specialized coloproctology evaluation in our teaching Hospital. A clinical examination was performed in all patients and information on bowel function, pregnancies, episiotomy, previous surgery and associated diseases were recorded. A preoperative informed consent was acquired in every case and the physicians explained to the patients the details and the aims of the procedures.

Each patient underwent a DTU by an expert coloproctologist (LB) with great experience of perineal ultrasonography, person in charge of a master of coloproctology and of master of pelvi-perineal rehabilitation at University of Study of Campania "Luigi Vanvitelli" of Naples. Subsequently, all patients underwent PNTML evaluation using the St. Marks glove mounted pudendal nerve stimulator (St. Mark's 13 L40® Dantec Elektronic, Skovlunde, Denmark), performed by a blinded neurophysiologist (FT).

Dynamic Transperineal Ultrasound Voluntary contraction of the perineum and of the PR muscle leads to a shortening of the PR muscle itself. The anal canal moves in the direction of the pubic bone and diminishes the anorectal angle. In contrast, relaxation of the PR muscle, which occurs while attempting defecation, lengthens the PRS and opens the anorectal angle. Contraction and relaxation of the PR muscle can be measured with DTU. DTU, in fact, is a morphological and functional procedure assessing puborectal function. It is cheap, feasible, well tolerated and reproducible. The patient is placed in the dorsal lithotomy position, with hips flexed and abducted, and a 3-6 MHz conventional convex transducer and field of view at least 70° positioned on the perineum between the mons pubis and the anal margin. In the mid-sagittal plane, all anatomical structures (bladder, urethra, vaginal walls, anal canal and rectum) between the posterior surface of the symphysis pubis and the posterior part of the levator ani are visualized3. [Figure 1] The probe is progressively inclined until the anal sphincter is visible. Changing application pressure and probe inclination, allows to scan the entire anal canal in transversal section. After the sphincter identification, a further longitudinal image obtained with a 90° rotation of the scanning plane allows to observe the PR sling behind the rectum.

The first caliper is placed on the anterior border of the PR in resting position; the second one is placed on the anterior border of PR in straining or squeezing position in order to respectively obtain the measure AD or the PD.

In healthy patients, the AD should be more than 7mm during squeezing and the PD more than 6mm, during straining.

Pudendal nerve terminal motor latency Pudendal nerve terminal motor latency is an affordable technique to evaluate anal sphincter innervation; it reflects the conduction velocity of the fastest motor nerve fiber supplying the anal sphincter.

In order to execute the examination a glove-mounted electrode (St. Mark's 13 L40® Dantec Elektronic, Skovlunde, Denmark) is used to measure pudendal nerve conduction time.

It is inserted into the anal canal with patients laying in Sims position. Both right and left pudendal nerves are stimulated using a pulse of 50 V, for 0.1 ms at a rate of 1 pulse per second over the ischial spines until a reproducible latency is obtained.

We selected the shortest reproducible latency recorded for each patient according to the neurophysiologist opinion. Prolonged PNTML was defined as greater than or equal to 2.2 ms.

Being tested
Pudendal nerve terminal motor latency assessment
Keywords
fecal incontinence, pudendal neuropthy, pudendal nerve terminal motor latency
Medical subject headings
Fecal Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pudendal nerve terminal motor latency assessmentDevice

    Also called Dynamic transperineal Ultrasound

    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.

Study groups in NCT03933683
Study groupRoleWhat they receive
Pathologic GroupPatients affected by Fecal Incontinence
Receives: Device: Pudendal nerve terminal motor latency assessment
Control GroupHealty volunteers cohort
Receives: Device: Pudendal nerve terminal motor latency assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance between pudendal nerve motor latency and dynamic transperineal ultrasound for the evaluation of pudendal neuropathy

    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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Jan 2019
  3. Primary completion1 Mar 2019
  4. Study completion15 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
68 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03933683
Sponsor's protocol ID
229/19
Status last verified
Apr 2019
First submitted
27 Apr 2019
Last updated
2 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: There is not a plan to make IPD available

Publications

  • Brusciano L, Gambardella C, Roche B, Tolone S, Romano RM, Tuccillo F, Del Genio G, Terracciano G, Gualtieri G, Docimo L. Dynamic transperineal ultrasonography correlates with prolonged pudendal nerve latency in female with fecal incontinence. Updates Surg. 2020 Dec;72(4):1187-1194. doi: 10.1007/s13304-020-00838-y. Epub 2020 Jun 28.

    PubMed 32596803

Questions about this trial

What is this clinical trial studying?

An observational study of Fecal Incontinence, run by University of Campania Luigi Vanvitelli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance between pudendal nerve motor latency and dynamic transperineal ultrasound for the evaluation of pudendal neuropathy (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03933683, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.

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