RecruitingACTRN12623000471684

Healthy female volunteer study to examine the effect of different body positions and environment on defecation physiology

Sponsor

Royal North Shore Hospital - Northern Sydney Local Health District

Enrollment

40 participants

Start Date

Mar 22, 2023

Study Type

Interventional

Conditions

Constipation - Dyssynergic defecation

Summary

This study is a healthy volunteer study assessing anorectal function during defecation. The balloon expulsion study is one of the diagnostic tests used to assess dyssynergic defecation - condition where there is a poor coordination of pelvic floor muscle resulting in impaired defecation. In this study, participants will be asked to undergo anorectal ultrasound, anorectal manometry followed by rectal balloon expulsion tests in three different positions. Balloon expulsion time and the ease and comfort of balloon expulsion will be compared between different positions and environments. Result from this tests will contribute to further refining the interpretation and performing balloon expulsion test.

Eligibility

Sex: FemalesMin Age: 20 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Some people have difficulty with bowel movements due to a condition called dyssynergic defecation, where the pelvic floor muscles don't coordinate properly. One test doctors use to assess this is a balloon expulsion test — a small balloon filled with water is placed in the rectum, and you are asked to expel it while a specialist measures how long it takes and how comfortable it feels. This study involves healthy female volunteers being asked to undergo this test in three different body positions to see whether position affects the test results. Researchers also want to understand whether the usual clinical environment (a healthcare setting) affects performance compared to a more private setup. The study involves anorectal ultrasound and manometry (pressure measurements) alongside the balloon tests. You may be eligible if you are a female aged 20–75, speak English, and are eligible for Medicare in Australia. Women who are pregnant or breastfeeding, have gastrointestinal disorders, have had previous anorectal surgery, or take medications that affect bowel movement are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Firstly, participants will undergo baseline assessment that includes anorectal ultrasound and anorectal manometry. Anorectal ultrasound involves examination of the anal sphincters using a transrectal

Firstly, participants will undergo baseline assessment that includes anorectal ultrasound and anorectal manometry. Anorectal ultrasound involves examination of the anal sphincters using a transrectal ultrasound probe. Then participants will undergo anorectal manometry. Participants will have a flexible catheter inserted into rectum to measure the rectal and sphincter pressure during various manoeuvres including balloon expulsion. Rectal sensation will be measured by inflating rectal balloon. Healthy volunteers will be asked to expel rectal balloon in different settings - Supine and 2 sitting positions. For sitting positions: Setting 1) In a conventional toilet in privacy Setting 2) On a commode chair behind the curtain (partial privacy). Order in which balloons are expelled will be randomised. All participants will also undergo anorectal manometry and anal ultrasound. All procedures will be performed by either a doctor (gastroenterologist or advanced trainee for gastroenterology) or a specialist nurse. Participants will only need to attend one session lasting approximately 1-2 hours to complete the study.

Locations(1)

Royal North Shore Hospital - St Leonards

NSW, Australia

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ACTRN12623000471684