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.
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
- Conditions the study is for
- Multiple Sclerosis, Anorectal Disorders, Bladder Dysfunction
- 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.
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.
- Conditions
- Multiple Sclerosis, Anorectal Disorders, Bladder Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted15 Aug 2019
- Study start26 Jul 2019
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
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 Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérard Amarenco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gérard Amarenco, Pierre and Marie Curie University
- Investigators
- Gérard Amarenco, PUPH, Principal investigator, Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Need to Void on Rectal Sensory Function in Multiple Sclerosis, a Manometric Study
- ClinicalTrials.gov ID
- NCT04057222
- Acronym / sponsor ID
- GRC-01GREEN
- Conditions
- Multiple Sclerosis, Anorectal Disorders, Bladder Dysfunction
- Keywords
- Rectal sensory function, Multiple sclerosis, anorectal disorders, Fecal incontinence, constipation, bladder sensation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gérard AmarencoUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 15 Aug 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients included | – | Other: No interventionPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- Multiple sclerosis
- > 18 years old
- Anorectal disorders
Key exclusion criteria (3 listed)
- full rectal ampullae
- No bladder sensation
- inability to understand simple orders
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 |
|---|---|---|
| No interventionOnly propose water and wait for need to void | Other | Patients included |
Primary outcome
Variation of volume of rectal constant sensation to need to defecate
Time frame: 1 Day
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
3 secondary outcomes
Variation of amplitude modulation of the RAIR between strong desire to void and just after
Time frame: 1 Day
Variation of duration modulation of the RAIR between strong desire to void and just after
Time frame: 1 Day
Variation of external anal sphincter resting pressure between strong desire to void and just after
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 32163639Pouyau 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.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
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.
Gérard Amarenco, PUPH principal investigator
Sorbonne Université, GRC 001, GREEN, AP-HP, Hôpital Tenon, Paris, France
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 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.