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
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →64 of the 376 studies in Multiple Sclerosis with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →376 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 29 started in 2019.
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.
130 of 376 have an industry lead sponsor. The 10 most frequent:
Gérard Amarenco is the lead sponsor of 9 studies on the registry; none are open to participants now.
Gérard Amarenco has 3 studies filed under Multiple Sclerosis — fewer than ten, so there is no comparison to draw.
18 of the studies in Multiple Sclerosis with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06141473Phase 3SanofiEfficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis | 2027-05-06 |
| NCT03653273Phase 3Rennes University HospitalDisease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP) | 2027-07 |
| NCT05519553Nantes University HospitalPeer Support Impact on Therapeutic Adherence in Patients With Multiple Sclerosis | 2026-12-01 |
| NCT07108088ÖSSUR FranceEvaluation of the NEUROSWING Orthosis on Walking Speed in a Population With Dorsal and/or Plantar Flexor Deficits, With a View to a Reimbursement Application | 2026-12-31 |
| NCT05772637Assistance Publique - Hôpitaux de ParisClinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis | 2027-02-14 |
Among the 376 studies in Multiple Sclerosis with a site in France, from their registry updates:
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.
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.
Exclusion Criteria:
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
Only propose water and wait for need to void
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
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
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
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
Plan to share: Undecided
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.
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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Gérard Amarenco