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MOWOOT Device Treatment for Adults With Chronic Constipation

NCT04666155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-04-13

No results posted yet for this study

Summary

The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.

Conditions

  • Constipation - Functional
  • Constipation-predominant Irritable Bowel Syndrome
  • Constipation Chronic Idiopathic
  • Constipation; Neurogenic
  • Constipation

Interventions

DEVICE

Intermittent Colonic Exoperistalsis with MOWOOT device

Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both.

DEVICE

Standard of care with Trans-Anal Irrigation

Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both.

Sponsors & Collaborators

  • County Durham and Darlington NHS Foundation Trust

    collaborator OTHER_GOV

  • University of York

    collaborator OTHER

  • usMIMA S.L.

    lead INDUSTRY

Principal Investigators

  • Immaculada Herrero, PhD · usMIMA S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2026-04-02
Completion
2026-04-02

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04666155 on ClinicalTrials.gov