Obstetric Anal Sphincter Injury
Conditions
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 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.
Interventions
DEVICETHD® Anopress (Sensyprobe) first
Anorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie)
DEVICEHigh Resolution Anorectal Manometry first
Anorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe)
Sponsors
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Main voluntary squeeze increment | Day 1 | Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anal resting pressure (mmHg) | Day 1 | Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on anal resting pressures (mmHg) |
| Main voluntary squeeze increment | Day 1 | difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg) |
| Endurance squeeze pressure | Day 1 | 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) |
| Straining pressure | Day 1 | Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on straining pressure (mmHg) |
| Total duration of procedure | Day 1 | Time from commencement to end of procedure (minutes and seconds) |
| Visual Analogue Scale (VAS) | Day 1 | Visual Analogue Scale -10 points (0-10), with 0 being 'no pain' and 10 being 'worst pain imaginable' |
| Adverse events | Day 1 | Any adverse reactions ie. patient injury, severe discomfort, medical emergencies encountered |
Countries
United Kingdom
Outcome results
None listed