A Comparison of THD® Anopress With High Resolution Anorectal Manometry
NCT ID: NCT07083908
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-03-01
2030-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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THD® Anopress (Sensyprobe) first
THD® Anopress (Sensyprobe) first
Anorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie)
High Resolution Anorectal Manometry first
High Resolution Anorectal Manometry first
Anorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe)
Interventions
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THD® Anopress (Sensyprobe) first
Anorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie)
High Resolution Anorectal Manometry first
Anorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe)
Eligibility Criteria
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Inclusion Criteria
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
2. Neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinson's disease
3. Age \<18 years old
4. Currently pregnant -
18 Years
FEMALE
Yes
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Locations
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Kings College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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350163
Identifier Type: -
Identifier Source: org_study_id
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