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.
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.
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.
- Conditions
- Fecal Incontinence
- 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 group | Role | What they receive |
|---|---|---|
| Pathologic Group | Patients affected by Fecal Incontinence Receives: Device: Pudendal nerve terminal motor latency assessment | |
| Control Group | Healty 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.
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.
- First posted1 May 2019
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Brusciano, University of Campania Luigi Vanvitelli
- Investigators
- Luigi Brusciano, Prof, Principal investigator, University of Campania Luigi Vanvitelli
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Non-invasive Evaluation of Pudendal Neuropathy by Dynamic Transperineal Ultrasound in Patients With Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT03933683
- Acronym / sponsor ID
- 229/19
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, pudendal neuropthy, pudendal nerve terminal motor latency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathologic Group | – | Device: Pudendal nerve terminal motor latency assessmentPatients affected by Fecal Incontinence |
| Control Group | – | Device: Pudendal nerve terminal motor latency assessmentHealty volunteers cohort |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- age ≥16
- symptoms of faecal incontinence
Key exclusion criteria (2 listed)
- past history of anorectal or vaginal surgery
- history of pelvic radiation or tumors -inability to complete the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve terminal motor latency assessmentAlso: Dynamic transperineal UltrasoundAfter 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. | Device | Control Group, Pathologic Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Derived from this study: PubMed 32596803Brusciano 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Brusciano, Prof principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
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.