A Comparison of THD® Anopress With High Resolution Anorectal Manometry

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). This test is performed to help advise patients on future pregnancies or deliveries. However, HDRM catheters are very expensive 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. 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. The primary aim of this study is to compare pressure measurements from HDARM to that of THD® Anopress in women with obstetric anal sphincter injuries.

NCT Number	NCT07083908
Lead Sponsor	King's College Hospital NHS Trust
Conditions	Obstetric Anal Sphincter Injury
Enrollment	53 participants
Start Date	2025-03-01
Primary Completion	2025-11-11 (estimated)
Study Completion	2025-11-11 (estimated)
Updated on ClinicalTrials.gov	2026-04-16