Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07083908
NA

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Sponsor: King's College Hospital NHS Trust

View on ClinicalTrials.gov

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). 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.

Official title: Sphincter Pressures in Women With Obstetric Anal Sphincter Injury: A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-01

Completion Date

2030-10

Last Updated

2025-07-24

Healthy Volunteers

Yes

Interventions

DEVICE

THD® Anopress (Sensyprobe) first

Anorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie)

DEVICE

High Resolution Anorectal Manometry first

Anorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe)

Locations (1)

Kings College Hospital

London, United Kingdom