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Multiple SclerosisNCT04057222

Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis

An observational study of Multiple Sclerosis and Anorectal Disorders, run by Gérard Amarenco at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. Read more about this study

Who is it for?
Ages 18 years and older
How many people
30 participants
Where
1 siteFrance
Study dates
26 Jul 2019to 6 Sep 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included.

Who may be able to join

  • Multiple sclerosis
  • > 18 years old
  • Anorectal disorders

Who cannot join

  • full rectal ampullae
  • No bladder sensation
  • inability to understand simple orders

Trial locations and contacts

1 site in 1 country.

France1 site
  • department of Neuro-Urology, Hôpital Tenon

    Paris, 70020

Other trials in France

About this study

Official title: Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis, a Manometric Study

Multiple sclerosis causes demyelinating lesions, which can induce multiple symptoms. Ano-rectal avec urinary disorders are frequent due to specific lesions in inhibitor/activator encephalic centers, or interruption on medullary conduction. It seems to be evident that anorectal and urinary disorders are link, because of similar anatomic ways and control process.

To our knowledge several studies test the effect of rectal distension and bladder sensory function but only one study examined the effect of bladder filling on rectal sensitivity on healthy people. The effect of bladder filling on rectal sensory function in patient with neurological disease stay unknown, while dysfunction often occur concomitant, and therapeutic actions in one organ may influence function of the other.

Read more

Anorectal manometry is the gold standard for the evaluation of rectal sensory function and the volume of constant sensation to need to defecate is reported in literature as the most reproducible measure.

Primary aim is to assess the effect of need to void on volume of constant sensation to need to defecate in multiple sclerosis with anorectal symptoms. Secondary aim is to identify the effect of need to void on modulation of rectoanal inhibitory reflex (RAIR) and external anal sphincter resting pressure.

Patient with multiple sclerosis over 18 years old, consulting for anorectal disorders in a tertiary center, with an indication to realize an anorectal manometry are included.

History and treatment, height, weight, Expanded Disability Status Scale (EDSS), anorectal and urinary symptoms severity by Bristol, Neurogenic Bowel Dysfunction (NBD), Cleveland, Kess, Urinary Symptom Score (USP) scores, and last urodynamic data are recorded. Patient are asked to drink water until they feel a strong need to void, for which they would go to urinate at home. 3 void volume with portable sonography are done, and the higher is recorded.

Anorectal manometries are realized by the same doctor, in a specific place, with calm. Before the manometric examination, thermal and vibratory sensory thresholds on the right hand are collected. The patient is then placed in a left lateral position. Then the anorectal manometry's catheter is inserted and collect of the external anal sphincter resting pressure begins. Then the investigator proceed to search for RAIR by 5 brief distensions of the intrarectal balloon with increasing volumes of 10 mL from 10 mL to 50 mL. Finally, the investigator collect the threshold volumes of perception, need and maximum tolerable by gradually distending the intra-rectal balloon to 5 mL/s from 0 mL to 300 mL. Toilets are just next to the table of examination.

Next, patient can urinate. 3 post void residual volume with portable sonography are done, and the higher is recorded.

The same tests are realized after urinate, in the same order. After the classical complete manometry was performed.

Primary outcome is the volume of constant sensation to need to defecate Secondary outcomes are the modulation of RAIR and the external anal sphincter resting pressure. Manometric data are collected.

Influence of age, EDSS, severity of symptoms, manometric data and detrusor overactivity on rectal sensory function will be study in secondary analysis.

Being tested
No intervention
Keywords
Rectal sensory function, Multiple sclerosis, anorectal disorders, Fecal incontinence, constipation, bladder sensation
Medical subject headings
Multiple Sclerosis, Rectal Diseases, Fecal Incontinence, Constipation

What participants receive

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

  • No interventionOther

    Only propose water and wait for need to void

Study groups in NCT04057222
Study groupRoleWhat they receive
Patients includedPatient with multiple sclerosis and anorectal symptoms, with indication to realize a anorectal manometry, age > 18 A first record of rectal sensory function will be at strong desire to void. A second record will be after void. Rectal sensory function records consist on an anorectal manometry with 3 measures of external anal sphincter resting pressure, 5 measures of RAIR, 1 measure of perception, constant sensation to need to defecate and maximum tolerable threshold volumes.
Receives: Other: No intervention

What is being measured

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

  1. Variation of volume of rectal constant sensation to need to defecate

    Difference between volume of rectal constant sensation to need to defecate at strong desire to void and post void, collected by patient declaration when distending the intra-rectal balloon by manual air insufflation at 5 mL/s during

    Measured: 1 Day

Secondary outcomes (3)
  1. Variation of amplitude modulation of the RAIR between strong desire to void and just after

    Difference between amplitude modulation of the RAIR at strong desire to void and post void calculated by difference between two non-successive residual pressure values on five successive distension volumes.

    Measured: 1 Day

  2. Variation of duration modulation of the RAIR between strong desire to void and just after

    Difference between duration modulation of the RAIR at strong desire to void and post void calculated by difference between two non-successive residual pressure values on five successive distension volumes.

    Measured: 1 Day

  3. Variation of external anal sphincter resting pressure between strong desire to void and just after

    Difference between external anal sphincter resting pressure at strong desire to void and post void

    Measured: 1 Day

Timeline

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

  1. First posted15 Aug 2019
  2. Study start26 Jul 2019
  3. Primary completion6 Sep 2019
  4. Study completion6 Sep 2019

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
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057222
Sponsor's protocol ID
GRC-01GREEN
Status last verified
Nov 2019
First submitted
12 Aug 2019
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pouyau C, Grasland M, Leroux C, Chesnel C, Turmel N, Sheikh Ismael S, Le Breton F, Amarenco G, Hentzen C. Relationship between desire to void and bladder capacity and rectal sensory function in patients with multiple sclerosis and anorectal disorders. Neurourol Urodyn. 2020 Apr;39(4):1129-1136. doi: 10.1002/nau.24330. Epub 2020 Mar 12.

    PubMed 32163639

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Anorectal Disorders, run by Gérard Amarenco at 1 site in France.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Nov 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Variation of volume of rectal constant sensation to need to defecate (time frame: 1 Day). 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 NCT04057222, 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 29 Nov 2019.

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