Comparison of anorectal biofeedback therapy delivered by home-based device with clinic-based anorectal manometry in patients with functional defecation disorders

Not Applicable

• Conditions: Functional defecation disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000583741
• Lead Sponsor: Western Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-20
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Males and females 18 to 65 years
• Diagnosed with urge faecal incontinence or faecal seepage
• Able to provide verbal and written consent

Exclusion Criteria

• Pregnant women and the human foetus
• People under the age of 18
• People with a cognitive impairment, an intellectual disability or a mental illness
• Anorectal surgery within the last 3 years
• Presence of active anal fissure and/or symptomatic haemorrhoids
• Individuals with implantable or portable electro-mechanical medical devices (e.g. pacemaker, sacral nerve stimulation impact)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anorectal exercise profiles generated by the experimental device compared against those from conventional anorectal manometry. <br><br>[Baseline and weekly after intervention commencement over a period of 6 weeks. ];Anorectal exercise pressures generated by the experimental device compared against those from conventional anorectal manometry. [Baseline and weekly after intervention commencement over a period of 6 weeks. ]

Secondary Outcome Measures

Name	Time	Method
Incontinence symptom severity using Vaizey and Wexner faecal incontinence scores <br><br>[Baseline and weekly after intervention commencement over a period of 6 weeks. ];.Incontinence episode frequency using faecal incontinent diary (days per week)[Baseline and weekly after intervention commencement over a period of 6 weeks. ]