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A Comparison of THD® Anopress With High Resolution Anorectal Manometry

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Female patients with a history of obstetric anal sphincter injury and are:
    1. At least 6 weeks postpartum
  2. Either able to speak, read and write in English, or has a professional interpreter

    present at the time of appointment.

  3. Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
  4. Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.

Exclusion Criteria:

  1. Existing anal pain precluding anorectal examination
  2. Neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinson's disease
  3. Age <18 years old
  4. Currently pregnant -

Study details
    Obstetric Anal Sphincter Injury

NCT07083908

King's College Hospital NHS Trust

1 August 2025

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