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CompletedNCT04057222Updated Nov 29, 2019

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

An observational study in Multiple Sclerosis, Anorectal Disorders and Bladder Dysfunction, sponsored by Gérard Amarenco. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by Gérard Amarenco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 376 studies in Multiple Sclerosis with a site in France — 64 open to participants now, 93 under way, 18 of them phase 3. Multiple Sclerosis · France.

Enrollment
122nd of 132
30 · median 174
Started
2019
with 28 others
Observational
132 of 376
22 open now
Registered
218th of 376
by date

Among the 376 studies in Multiple Sclerosis with a site in France, this one is the 122nd largest by enrollment of the 132 observational ones, is one of 29 that started in 2019, is one of 132 observational ones, and was the 218th registered.

By phase

376 studies; the count open now beside each. This study's row is marked.

Observationalthis study132 · 22 open
No phase110 · 32 open
Phase 377 · 6 open
Phase 225 · 1 open
Phase 425 · 1 open
Phase 14 · 2 open
Phase 1/23 · 0 open

By the year they started

First in 1999; this study’s year is marked. 29 started in 2019.

Size and results

Median enrollment 144 across the 244 interventional studies, 174 across the 132 observational. Of the 253 that completed or were terminated, 68 (27%) have results posted.

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02

Study 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. 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.

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.

03

Conditions studied

  • Multiple Sclerosis
  • Anorectal Disorders
  • Bladder Dysfunction

Keywords

  • Rectal sensory function
  • Multiple sclerosis
  • anorectal disorders
  • Fecal incontinence
  • constipation
  • bladder sensation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Multiple sclerosis
  • > 18 years old
  • Anorectal disorders

Exclusion criteria

Exclusion Criteria:

  • full rectal ampullae
  • No bladder sensation
  • inability to understand simple orders
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients included

    Patient 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.

    Other: No intervention

Interventions

  • OtherNo intervention

    Only propose water and wait for need to void

06

What researchers measure

Primary outcomes

  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

    Time frame: 1 Day

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 1 Day

07

Study locations

1 site
  • department of Neuro-Urology, Hôpital Tenon
    Paris, 70020, France
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Sep 2019, 1 month.

Of 334 non-industry observational studies under Multiple Sclerosis, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 73. This study's 1 month is below that.

Counting every sponsor, half of 425 studies reached it within 41 months; a quarter within 15 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2019
First posted
Aug 15, 2019
StartActual
Jul 26, 2019
Primary completionActual
Sep 6, 2019
CompletionActual
Sep 6, 2019
Last update
Nov 29, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04057222
Lead sponsor
Gérard Amarenco
Responsible party
Gérard Amarenco (Head of Neuro-Urology department, Tenon Hospital, Pierre and Marie Curie University) — Sponsor-investigator
First posted
Aug 15, 2019
Start date
Jul 26, 2019
Primary completion
Sep 6, 2019
Completion
Sep 6, 2019
Last update
Nov 29, 2019

Study contacts

Gérard Amarenco, PUPH
principal investigator · Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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