Home solution for a sensitive problem

Chronic constipation and faecal incontinence could soon be treated in the privacy of one’s home if clinical trials are successful.

Despite it being a natural part of the digestive process, no-one really wants to talk about what they do in the toilet.

Therefore, when many people develop gastrointestinal disorders, particularly faecal incontinence, the tendency is to not seek medical help. This can mean people with this condition can suffer silently for years when the problem can be resolved with a treatment known as anorectal biofeedback.

Anorectal biofeedback is the first-line treatment option for people suffering chronic constipation and faecal incontinence with a high response rate and favourable longterm outcomes. Up until now, the treatment in NSW has only been available in a few hospitals which has resulted in long waiting times for care. However, a new feasibility study and controlled trial, hopes to bring this treatment out of the hospital and into patients’ homes providing help for thousands of people who may not have access to hospital treatment or who may be too embarrassed to seek help.

Led by Dr Jerry Zhou from Western Sydney University (WSU), the “Clinical trial of a new Internetof-Medical-Things device for home-based treatment of anorectal disorders,” funded by SPHERE’s Frontiers Technology Clinical Academic Group, includes two

studies: a pilot feasibility study and a parallel arm randomised controlled trial.

But first, what is anorectal biofeedback?

“It’s a therapy that’s very effective in people with chronic constipation and faecal incontinence. These two disorders are usually functional disorders, meaning there is nothing anatomically wrong but rather the muscles responsible for proper defaecation are not functioning correctly,” explains Dr Zhou.

In the case of faecal incontinence, this is the result of weak anal sphincter muscles which may have sustained damage during pregnancy or extensive obstetric history such as multiple births. In chronic constipation, the discoordination between the muscles of the stomach (which need to contract) and the anal sphincter muscles (which need to relax) make going to the toilet extremely difficult.

This is where anorectal biofeedback can help.

Anorectal biofeedback utilises a probe-like device which is inserted into the anal passage. The patient is then guided to contract and relax whilst the device measures the contractions providing the user with visual and/or audio feedback about the strength of these contractions.

“This form of biofeedback is very effective. About 85-90% of cases get long-term improvement in bowel habits. However, there are some problems with the traditional approach. Firstly, there are not many clinics in NSW providing this treatment which means that literally thousands of people, particularly from rural and remote areas, who could benefit from this treatment do not have easy access to it,” says Dr Zhou. “And because the treatment is only available at a handful of hospitals, patients can wait four to six months to begin treatment. Also, appointments are time-consuming (typically six sessions 1-2 weeks apart with each about 30-60 minutes long) followed by a reinforcement stage of three sessions at three, six and 12 months, which means that few patients complete the full therapy cycle,” Dr Zhou explains.

Based on data from major biofeedback clinics in NSW, only 10-30% of patients recommended for biofeedback therapy will actually undergo and/or complete the full course of therapy.

Due to these problems, Dr Zhou and his team developed an anorectal biofeedback device to be used as a home treatment. The device is paired to a mobile phone app which the inbuilt smart sensors then provide the user with real time information about their progress as they perform the exercises. This data is then shared with the clinician who remotely monitors the patient’s progress.

The research

“This form of biofeedback is very effective. About 85-90% of cases get long-term improvement in bowel habits.”

The aim of the project is to conduct two studies. The first is a pilot feasibility study currently being conducted at Camden Hospital in south-west Sydney. The study aims to determine if the new device can provide home-based biofeedback therapy with minimal direct clinician supervision. The second part of the project is a randomised parallel controlled trial to compare home biofeedback using the new device against conventional clinic-based biofeedback. This randomised controlled trial will commence in February 2023 at Royal Prince Alfred Hospital. “A secondary objective is to prospectively assess whether home biofeedback is a more cost-effective alternative to the standard clinicbased therapy.”

Dr Zhou acknowledges that this is not the first time that a home-based biofeedback device has been trialled in Australia. However, previous attempts such as the Peritron Perineometer (an analogue air-pressure probe connected to a numerical readout) were not successful as therapists found it challenging to ensure correct exercises were performed at home and lack of technology meant therapists were unable to monitor patients effectively.

“With the internet of things and smart technology, we now have the technology to capture the data effectively and provide that data to both patients and clinicians in real time. This includes capturing key outcome parameters such as training adhesion, muscle tone changes, bowel symptoms which allows for enhanced clinician review and treatment evaluation.

“The acceptance of telehealth as a real alternative to face-to-face appointments has also helped to make this home-based treatment a reality.”

A real prospect for commercialisation

While the initial idea for the anorectal biofeedback device wasn’t for commercialisation purposes, Dr Zhou realised that treatment can be more accessible if the device is commercialised.

“We didn’t start this as a commercial project. We originally saw the need at Camden Hospital and wanted to create something in the lab to help the nurses providing the treatment. However, the more hospitals we spoke to the more we realised the potential for commercialisation because it is a real unmet need.”

“This is why we partnered with SPHERE’s Frontiers Technology CAG who provided initial funding. The study has also been supported with funding by Western Sydney University’s Western Venture program.”

Whilst the device won’t be available at your pharmacy just yet, there are plans to bring it to the market in the next few years.

“After the trial we aim to work towards getting TGA approval and setting up manufacturing and quality management systems to bring the device and app to the market.”

Dr Jerry Zhou