RecruitingNAINTERVENTIONAL

MowOot and Trans-anal Irrigation fOr coNstipation

This research is testing a new way to help people with ongoing constipation, called Intermittent Colonic Exoperistalsis (ICE). We're comparing it to the usual care, Trans-anal Irrigation (TAI), for those who haven't found relief with other treatments. The ICE treatment uses a special device called MOWOOT. Participants will either use the MOWOOT device daily for 12 weeks or continue with their standard TAI care. Doctors will explain both options, and you'll choose what feels right for you. The main goal is to see if the new treatment helps improve how satisfied people feel with their daily bowel management and their overall quality of life. We'll also look at how well ICE works to reduce constipation symptoms and if it saves hospital resources.

At a glance

Status

Recruiting

Phase

Sponsor

usMIMA S.L.

Enrolment target

Start

25 Jun 2025

Estimated completion

01 Sep 2026

Constipation Chronic Idiopathic

What is this study about?

This study is exploring a new treatment option for people who suffer from long-term constipation that hasn't responded to other remedies. This type of constipation is often called 'refractory chronic idiopathic constipation'. The new treatment is called Intermittent Colonic Exoperistalsis, or ICE for short, and it uses a device called MOWOOT. It's being compared with the current standard treatment, Trans-anal Irrigation (TAI), for people who are already on a waiting list for TAI.

The main idea is to see how well ICE treatment works to improve how people feel about their daily bowel management and their quality of life. We'll also look at whether it reduces constipation symptoms, how often people need other treatments, and how much time they spend on bowel care. The study aims to gather detailed information both from patients and from healthcare professionals involved in their care.

You'll be offered a choice between trying the ICE device or continuing with your standard TAI care for 12 weeks. Don't worry, healthcare professionals will explain both options fully and help you decide which might be best for you, but the final decision is always yours.

Key takeaways

This study tests a new device (MOWOOT) for long-term constipation.
It aims to improve satisfaction with bowel management and quality of life.
You'll choose between the new treatment or standard TAI care.
Participation lasts 12 weeks, with daily treatment for the ICE group.
Only adults with specific types of chronic constipation can join.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have long-term constipation. To be included, your constipation needs to be quite bothersome and not have improved with other treatments like biofeedback. You should also be on a waiting list for Trans-anal Irrigation (TAI).

It's important that you can use the MOWOOT device or TAI treatment yourself, or have someone who can help you every day. You'll also need to understand English, both spoken and written, so you can fill out the questionnaires.

There are also some reasons why you wouldn't be able to join. These include certain bowel conditions like Inflammatory Bowel Disease or severe Irritable Bowel Syndrome with diarrhoea, having had major bowel surgery, being pregnant, or having certain abdominal issues that would make the treatment uncomfortable. You also couldn't join if you're taking part in another clinical trial at the same time.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic constipation that hasn't responded to other treatments?
Are you currently on a waiting list for Trans-anal Irrigation (TAI)?
Can you understand written and spoken English for questionnaires?
Can you or a carer use the MOWOOT device or TAI daily?
Are you not pregnant or planning to be in the next 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be helped to choose between two groups: one will use the MOWOOT device for ICE treatment, and the other will continue with standard Trans-anal Irrigation (TAI) care. If you choose the ICE group, you'll use the MOWOOT device for 20 minutes daily, around the same time each day, for 12 weeks.

Throughout the 12 weeks, you'll be asked to complete questionnaires about your satisfaction with bowel management, constipation symptoms, and quality of life. Healthcare professionals will also track other details like how much time you spend on bowel care and any other treatments you use. You'll have visits to the Central Middlesex Hospital for assessments. The total duration of your active participation will be 12 weeks, followed by further data collection. You always have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in this study might offer you a potential benefit by exploring a new treatment for your chronic constipation that could improve your daily life and bowel habits. For some, using the MOWOOT device might be more convenient or effective than current treatments. However, like any treatment, there's always a chance it might not work for you, or you might experience some discomfort, though the MOWOOT device is designed for gentle abdominal massage. All known risks will be fully explained before you agree to take part. Remember, you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Sir Alan Parks Physiology & Pelvic Floor Biofeedback Unit., Central Hospital, Department of Physiology, St Mark's Hospital, The National Bowel Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'Intermittent Colonic Exoperistalsis' (ICE)?

ICE is a new treatment for constipation that uses a device called MOWOOT to gently massage your tummy, aiming to help your bowels move more regularly.

What is the MOWOOT device?

The MOWOOT device is a soft, belt-like device that you wear around your tummy. It gently massages your abdomen to help stimulate bowel movements.

What is 'Trans-anal Irrigation' (TAI)?

TAI is a method where water is gently introduced into the bowel through the bottom to help clear it, often used by people with severe constipation.

How long will I be in the study?

Your active involvement with the study treatment will last for 12 weeks, during which you'll either use the MOWOOT device or continue your usual TAI care.

Will I have to pay to be in the study?

No, you will not have to pay to take part in the study or for any of the treatments provided as part of the research.

How to find out more

Immaculada Herrero-Fresneda, PhD

ihf@mowoot.com +34 935106653 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.