MedTrace Logo

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

NCT07083908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Obstetric Anal Sphincter Injury

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)

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-11-11
Completion
2025-11-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07083908 on ClinicalTrials.gov