A Comparison of THD® Anopress With High Resolution Anorectal Manometry

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Obstetric Anal Sphincter Injury

Treatments: Device: THD® Anopress (Sensyprobe) first; Device: High Resolution Anorectal Manometry first

Study type: Interventional

Funder types: Other

Identifiers

NCT07083908

350163

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 -

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

THD® Anopress (Sensyprobe) first

Other group

Treatment:

Device: THD® Anopress (Sensyprobe) first

High Resolution Anorectal Manometry first

Other group

Treatment:

Device: High Resolution Anorectal Manometry first