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Completed

NCT Number: NCT07083908

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.

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Key information

Conditions

Obstetric Anal Sphincter Injury

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kings College Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients with a history of obstetric anal sphincter injury and are:

a) At least 6 weeks postpartum

  • Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.
  • Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
  • 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

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

Treatment and study plan

THD® Anopress (Sensyprobe) first

Device

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

High Resolution Anorectal Manometry first

Device

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

Primary outcomes

  1. Main voluntary squeeze increment

    Time frame: Day 1

    Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)

Secondary outcomes

  1. Anal resting pressure (mmHg)

    Time frame: Day 1

    Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on anal resting pressures (mmHg)

  2. Main voluntary squeeze increment

    Time frame: Day 1

    difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)

  3. Endurance squeeze pressure

    Time frame: Day 1

    Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on endurance squeeze pressures (increase of average pressure within 5 seconds of maximum squeeze) (mmHg)

  4. Straining pressure

    Time frame: Day 1

    Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on straining pressure (mmHg)

  5. Total duration of procedure

    Time frame: Day 1

    Time from commencement to end of procedure (minutes and seconds)

  6. Visual Analogue Scale (VAS)

    Time frame: Day 1

    Visual Analogue Scale -10 points (0-10), with 0 being 'no pain' and 10 being 'worst pain imaginable'

  7. Adverse events

    Time frame: Day 1

    Any adverse reactions ie. patient injury, severe discomfort, medical emergencies encountered

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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