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:
-
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 -
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