A Comparison of THD® Anopress With High Resolution Anorectal Manometry

NCT ID: NCT07083908

Last Updated: 2025-07-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2030-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstetric Anal Sphincter Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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THD® Anopress (Sensyprobe) first

Group Type OTHER

THD® Anopress (Sensyprobe) first

Intervention Type DEVICE

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

High Resolution Anorectal Manometry first

Group Type OTHER

High Resolution Anorectal Manometry first

Intervention Type DEVICE

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)

Intervention Type DEVICE

High Resolution Anorectal Manometry first

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

Intervention Type DEVICE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kings College Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Kar Yee Lor, MBChB

Role: CONTACT

+4420 3299 3568

Facility Contacts

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Kar Yee Lor, MBChB

Role: primary

+442032993568

Other Identifiers

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350163

Identifier Type: -

Identifier Source: org_study_id

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