A comparison of THD® Anopress with High Resolution Anorectal Manometry
Research type
Research Study
Full title
Sphincter Pressures in Women with Obstetric Anal Sphincter Injury: A comparison of THD® Anopress with High Resolution Anorectal Manometry
IRAS ID
350163
Contact name
R&D Office
Contact email
Sponsor organisation
Research & Development -Governance Manager
Duration of Study in the UK
5 years, 9 months, 9 days
Research summary
Currently, high resolution anorectal manometry (HDARM) is used as gold standard to measure anal sphincter pressures in women who have sustained a third or fourth degree perineal tears (obstetric anal sphincter injuries). We do this test to help advise patients on future pregnancies or deliveries. However, HDRM catheters are very expensive (£800 - £1500 + VAT according the the manufacturer) and they also need to be performed in a dedicated procedure room. THD® Anopress in comparison is a lightweight, portable device which has a comparatively shorter investigation time and is more cost- effective (£45 per catheter).
However, although THD® Anopress is currently used in the colorectal population, there is currently no validated research that compares the measurements obtained by HDARM with that of THD® Anopress with women with a history of obstetric anal sphincter injuries.
Our primary aim of this study is to compare pressure measurements from HDARM to that of THD® Anopress in women with obstetric anal sphincter injuries.
The THD® Anopress catheters (Sensyprobe) for the study have been very kindly provided by the manufacturer THDLabUK, but no other monetary funding has otherwise been provided. We will be recruiting women who had sustained third or fourth degree tears from either Kings College Hospital or Princess Royal Hospital.
REC name
London - Stanmore Research Ethics Committee
REC reference
25/LO/0028
Date of REC Opinion
25 Feb 2025
REC opinion
Further Information Favourable Opinion