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ConstipationNCT04262752

MOWOOT Device to Treat Constipation in Adults

A study testing intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device in people with Constipation and Constipation; Neurogenic, run by usMIMA S.L. at 3 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
11 Jan 2018to 7 Jun 2019
Phase
Interventional
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

Who may be able to join

  • Fulfil Rome III criteria for functional constipation: include any two of the six symptoms of straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, digital manoeuvres and less than 3 defecations per week. These should be present during at least 25% of defecations for the last 3 months with symptom onset at least 6 months before the diagnosis;
  • Failed routine management of constipation (lack of response to non-stimulant laxatives), or subjects responding to laxative treatment but with secondary diarrhoea and faecal incontinence.
  • Duration of constipation more than 6 months.
  • If subjects have a diagnosis of multiple sclerosis (MS) or Parkinson disease (PD), it is in a stable phase (no major change in medication for 1 month).
  • Subject that have had no abdominal massage for at least 2 months.
  • Subjects bothered by their constipation.
Show all 11Show fewer
  • Ability to understand the study
  • Ability to come to the outpatient clinic during the study
  • Subjects whose constipation aetiology is not only pelvic floor dyssynergia.
  • Ability to use MOWOOT or have someone to apply it.
  • Subjects that consent to participate in an informed way

Who cannot join

  • Pregnancy or attempt to become pregnant in the next 6 months.
  • Subjects alternating constipation and diarrhoea (not due to laxative use)
  • Previous large bowel surgery
  • The presence of a stoma
  • External rectal prolapse
  • Active anorexia or bulimia
Show all 16Show fewer
  • Mental inability to give informed consent
  • Active abdominal cancer
  • Large inguinal or umbilical hernia
  • Inflammatory Bowel Disease (IBD)
  • Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
  • Intra-abdominal implants (catheters, SARS, medication pumps…)
  • Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 month.
  • Inability to undertake the massage with the device themselves or the lack of a carer willing to do it.
  • Participation in another parallel clinical trial or less than 2 month from participation in a previous clinical trial
  • Subjects who do not consent to participate.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Spain2 sites

  • Hospital de Terrassa

    Terrassa, Barcelona

  • Hospital Universitari MútuaTerrassa

    Terrassa, Barcelona

Other trials in Spain

United Kingdom1 site

  • Glasgow Caledonian University

    Glasgow, Scotland

Other trials in United Kingdom

About this study

Official title: Automatic Colon-specific Massage With MOWOOT Medical Device to Treat Chronic Constipation in Adults

The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use settings could ameliorate constipation in chronically affected people.

Read the detailed description

The study is an international multi-centre trial using an experimental strategy of once daily abdominal massage using MOWOOT for 4 weeks.

The trial includes a 2-week pre-intervention period with the usual constipation treatment without MOWOOT, followed by a 4-week intervention period consisting of 20 minutes' daily massage with MOWOOT (with or without the usual constipation treatment, as required by subject), followed by 1week wash-out period and finished by 2 weeks' post-intervention follow-up period. The same outcome measures will be assessed before and immediately after the treatment, and again after a washout period.

The principal endpoint of the procedure will be based on constipation improvement (complete bowel movements per week). The secondary endpoints will be based on chronic constipation defined as Rome III criteria assessed by the KESS score, Bristol scale, colonic transit time, dose of laxatives and/or other measures to assist defecation and quality of life. These secondary endpoints regarding defecatory function will be evaluated during intervention and compared with 2 weeks before intervention and 2 weeks after intervention following one week of wash out.

The null hypothesis (H0) is that there is no difference between before and after treatment, against an alternative hypothesis (H1) assuming a difference between the treatments.

Two tailed tests with 95% confidence intervals will be produced for the comparisons of interest in order to investigate the magnitude of treatment effects.

MOWOOT is a "wearable" medical device which emulates the massage techniques used by the professional therapists in order to provide a colon-specific abdominal massage. The product is focused on people who suffer from chronic constipation due to neurogenic bowel disease and prolonged intestinal transit time.

MOWOOT is composed by two main pieces: the desktop device and the massager belt. The desktop device provides the source of energy as well as it contains the panel control which allows the management of the device function and allows to select the treatment time and pressure. The massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.

Being tested
intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device
Medical subject headings
Constipation

What participants receive

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

  • intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical deviceDevice

    The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.

    The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device.

    For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period.

Study groups in NCT04262752
Study groupRoleWhat they receive
chronically constipated peopleExperimentalAdults with chronic constipation due to either neurogenic bowel dysfunction (NBD) as consequence of a neurogenic condition such as Multiple sclerosis or Parkinson Disease, or to unkwon origin (Idiopathic No-NBD)
Receives: Device: intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device

What is being measured

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

  1. Number of complete bowel movements per week

    Complete bowel movements mean that the subjects feel they have emptied their bowels completely.

    Measured: Daily for 9 weeks

Secondary outcomes (8)

  1. Changes in Constipation symptoms according to the KESS score

    Knowles Eccersley Scott Symptom Score (KESS) is an 11-item questionnaire to diagnose constipation. The assessed items are duration of constipation, laxative use, frequency of bowel movements, unsuccessful evacuatory attempts, feeling incomplete evacuation, abdominal pain, bloating, enemas/digitation, time taken, difficulty evacuation, and stool consistency. Total score ranges from 0 (no symptoms) to 39 (high symptom severity). A cut-off score of ≥ 11 indicates constipation.

    Measured: Once a week at weeks 2, 6 and 9

  2. Changes in fecal consistency according to Bristol scale

    Bristol stool scale is a worldwide used visual analogue scale that semi-quantitatively assesses faecal consistency from 1 (hard, pellet feces) to 7 (liquid diarrhea). Categories 1 and 2 indicate constipation, 3 and 4 are considered normal, and 5 to 7 indicate soft to liquid feces.

    Measured: Once a week at weeks 2, 6 and 9

  3. Changes in Colonic transit time (CTT)

    Colonic transit time (CTT) involved the ingestion of 20 radio-opaque markers followed by a single plain abdominal x-ray 5 days later.

    Measured: Once a week at weeks 2 and 6

  4. Changes in laxative consumption per week

    Patients should record on the Bowel diary the names and dose of laxatives, as well as the number of days taking laxatives, among other variables (desire to defecate, number of complete defecations, number of unsuccessful evacuation attempts, painful evacuation, abdominal pain, time taken to evacuate, straining effort, feeling of incomplete evacuation, other symptoms as bloating, influence of constipation on daily activities, need of digital assistance, and concomitant medication)

    Measured: Daily for 9 weeks

  5. Changes in other manoeuvres needed to assist defecation per week

    Patients should record on the Bowel diary any other manoeuvres needed to assist defecation (such as enemas, digitation, etc.; names and dose) among other variables (desire to defecate, number of complete defecations, number of unsuccessful evacuation attempts, painful evacuation, abdominal pain, time taken to evacuate, straining effort, feeling of incomplete evacuation, other symptoms as bloating, influence of constipation on daily activities, laxatives, and concomitant medication)

    Measured: Daily for 9 weeks

  6. Changes in quality of life according to PAC-QoL

    The PAC-QoL is a validated self-reported questionnaire that measures quality of life of subjects with constipation. It is composed of 28 items grouped into four subscales: physical discomfort, psychosocial discomfort, worried and concerns, and satisfaction. Each item is scored from 0 to 4. The lower the score the better quality of life

    Measured: Once a week at weeks 2, 6 and 9

  7. Changes in subject satisfaction according to a visual analogue scale

    Patients were asked to rate their individual satisfaction with bowel function by answering the question "How do you feel about your defecatory function?" on a visual analogue scale (VAS) from 0 ("No problems to defecate") to 10 ("A lot of problems to defecate").

    Measured: Once a week at weeks 2, 6 and 9

  8. Adherence to treatment

    The number of completed treatments and the total minutes of each treatment received (completed or not) are automatically registered by the software of the MOWOOT device.

    Measured: Once a week during the 4 weeks of the interventional treatment

Timeline

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

  1. First posted10 Feb 2020
  2. Study start11 Jan 2018
  3. Primary completion13 May 2019
  4. Study completion7 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Each subject in the study will be his/her own control in a BEFORE-AFTER Study, with one group assessed before intervention, during intervention and after intervention. Additionally, in order to discuss and analyse the results, further subgroups could be made on the basis of aetiology of the chronic constipation to compare results, i.e.: subjects with constipation derived from Neurogenic Bowel Disease (NBD) vs Idiopathic (No NBD) subjects whose constipation is from unknown origin
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04262752
Sponsor's protocol ID
MOW-01-2017
Status last verified
Apr 2021
First submitted
31 Jan 2020
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Available under demand. Contact with the Chief Scientific Officer of USMIMA S.L by mail: ihf@mowoot.com

Publications

  • Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0.

    PubMed 17117000

  • Azpiroz F, Enck P, Whitehead WE. Anorectal functional testing: review of collective experience. Am J Gastroenterol. 2002 Feb;97(2):232-40. doi: 10.1111/j.1572-0241.2002.05450.x.

    PubMed 11866256

  • Bracci F, Badiali D, Pezzotti P, Scivoletto G, Fuoco U, Di Lucente L, Petrelli A, Corazziari E. Chronic constipation in hemiplegic patients. World J Gastroenterol. 2007 Aug 7;13(29):3967-72. doi: 10.3748/wjg.v13.i29.3967.

    PubMed 17663511

  • Coggrave M, Wiesel PH, Norton C. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD002115. doi: 10.1002/14651858.CD002115.pub3.

    PubMed 16625555

  • Diego MA, Field T, Hernandez-Reif M, Deeds O, Ascencio A, Begert G. Preterm infant massage elicits consistent increases in vagal activity and gastric motility that are associated with greater weight gain. Acta Paediatr. 2007 Nov;96(11):1588-91. doi: 10.1111/j.1651-2227.2007.00476.x. Epub 2007 Sep 21.

    PubMed 17888059

  • Evans RC, Kamm MA, Hinton JM, Lennard-Jones JE. The normal range and a simple diagram for recording whole gut transit time. Int J Colorectal Dis. 1992 Feb;7(1):15-7. doi: 10.1007/BF01647654.

    PubMed 1588218

  • Harari D, Norton C, Lockwood L, Swift C. Treatment of constipation and fecal incontinence in stroke patients: randomized controlled trial. Stroke. 2004 Nov;35(11):2549-55. doi: 10.1161/01.STR.0000144684.46826.62. Epub 2004 Oct 14.

    PubMed 15486330

  • Knowles CH, Eccersley AJ, Scott SM, Walker SM, Reeves B, Lunniss PJ. Linear discriminant analysis of symptoms in patients with chronic constipation: validation of a new scoring system (KESS). Dis Colon Rectum. 2000 Oct;43(10):1419-26. doi: 10.1007/BF02236639.

    PubMed 11052520

  • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

    PubMed 9299672

  • Liu Z, Sakakibara R, Odaka T, Uchiyama T, Yamamoto T, Ito T, Hattori T. Mechanism of abdominal massage for difficult defecation in a patient with myelopathy (HAM/TSP). J Neurol. 2005 Oct;252(10):1280-2. doi: 10.1007/s00415-005-0825-9. Epub 2005 May 20. No abstract available.

    PubMed 15895308

  • Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.

    PubMed 16678561

  • Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.

    PubMed 16036506

  • McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.

    PubMed 21520798

  • Ng C, Prott G, Rutkowski S, Li Y, Hansen R, Kellow J, Malcolm A. Gastrointestinal symptoms in spinal cord injury: relationships with level of injury and psychologic factors. Dis Colon Rectum. 2005 Aug;48(8):1562-8. doi: 10.1007/s10350-005-0061-5.

    PubMed 15981066

  • Nortvedt MW, Riise T, Frugard J, Mohn J, Bakke A, Skar AB, Nyland H, Glad SB, Myhr KM. Prevalence of bladder, bowel and sexual problems among multiple sclerosis patients two to five years after diagnosis. Mult Scler. 2007 Jan;13(1):106-12. doi: 10.1177/1352458506071210.

    PubMed 17294618

Questions about this trial

What is this clinical trial studying?

A study testing intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device in people with Constipation and Constipation; Neurogenic, run by usMIMA S.L. at 3 sites in 2 countries.

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 11 inclusion and 16 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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain, United Kingdom. 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?

Number of complete bowel movements per week (time frame: Daily for 9 weeks). 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 NCT04262752, which also lists 28 linked publications.

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 23 Apr 2021.

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