New approach to assessing pelvic floor function

If you are eligible and willing to participate in this trial, you will be invited to undergo the following procedures:

(1) Anorectal manometry and ultrasound: This involves the insertion of a thin catheter (hollow tube) into your rectum (back passage) while you are lying on your left side on a bed. This catheter is connected to the equipment that measures pressure while you squeeze or strain your anal muscles and cough. You will also have small electrodes attached around your anus and on your abdomen. Following this, a small balloon will be inflated inside your rectum, and you will be asked to rate the sensations felt at different balloon volumes. Then you will be asked to expel the balloon filled with water whilst we continue to measure sphincter muscle pressure. Anorectal/Perineal ultrasound involves inserting an ultrasound probe into the rectum to visualise the sphincter muscles and may take a few minutes to complete.

(2) Balloon expulsion test: Lastly, you will be requested to try to expel the balloon in three different positions – One lying down and two in sitting positions. For sitting positions, you will pass a balloon in a commode behind a curtain and in a private toilet. You will therefore have plastic tubes inserted four times in total(once during anorectal manometry). This will be done with lubricant for your comfort and ease of insertion.

A physician or a nurse specialist will perform the procedures. The study should take approximately 1-1.5 hours. All procedures will be done discretely and with consideration for your privacy. No special preparation such as fasting or bowel preparation is required. These procedures can cause minor discomfort, but careful technique will minimise this.
Upon completion of the procedure, you will be asked to grade the comfort/ease of performing a balloon expulsion study in each position on a visual analogue scale (1-10) and choose the most comfortable position.

Finally, we will ask you to fill in the food and stool diary for seven days following the procedure. Stool and diary are filled on the premade forms. Filling in these diaries should not take more than 15 minutes every day (5 minutes each at breakfast, lunch and dinner) to fill in this form. The stool diary requires information such as the consistency of stool and pain during defaecation. For the food diary, you simply need to list food items you have consumed for the day. You can send these two diaries back to us via mail or email. If you choose the mailing option, you will be provided with a prepaid envelope. 

You may be eligible to participate in this study if you:

• Age 20 to 75
• Females
• English speakers
• Patients who are eligible for Medicare benefit in Australia
• Willingness to answer screening questionnaire
• Willingness to give written informed consent
• Willingness to comply with the study. 

If you are interested in assisting with this important and exciting area of research, please use below link to register interest:
http://redcap.link/hbet23

Otherwise please email us to ask more questions:
NSLHD-ngresearch@health.nsw.gov.au

Ethics approval number: 2022//ETH006600 Northern Sydney Local Health District