Status:

COMPLETED

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Lead Sponsor:

King's College Hospital NHS Trust

Conditions:

Obstetric Anal Sphincter Injury

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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 ...

Eligibility Criteria

Inclusion Criteria:

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

    a) 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 -

Key Trial Info

Start Date :

March 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 11 2025

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT07083908

Start Date

March 1 2025

End Date

November 11 2025

Last Update

April 16 2026

Active Locations (1)

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1

Kings College Hospital

London, United Kingdom