A Comparison of THD® Anopress With High Resolution Anorectal Manometry

King's College Hospital NHS Trust50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Obstetric Anal Sphincter Injury

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Outcomes

Primary Outcomes

Main voluntary squeeze increment

Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)

Time frame: Day 1

Secondary Outcomes

Anal resting pressure (mmHg)

Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on anal resting pressures (mmHg)

Time frame: Day 1

Main voluntary squeeze increment

difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)

Time frame: Day 1

Endurance squeeze pressure

Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on endurance squeeze pressures (increase of average pressure within 5 seconds of maximum squeeze) (mmHg)

Time frame: Day 1

Straining pressure

Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on straining pressure (mmHg)

Time frame: Day 1

Total duration of procedure

Time from commencement to end of procedure (minutes and seconds)

Time frame: Day 1

Visual Analogue Scale (VAS)

Visual Analogue Scale -10 points (0-10), with 0 being 'no pain' and 10 being 'worst pain imaginable'

Time frame: Day 1

Adverse events

Any adverse reactions ie. patient injury, severe discomfort, medical emergencies encountered

Time frame: Day 1

A Comparison of THD® Anopress With High Resolution Anorectal Manometry

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts