A Comparison of THD® Anopress With High Resolution Anorectal Manometry

NCT07083908 | Completed

• 1 other identifier: 350163
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Anal Sphincter Injury

Outcome Measures

Primary Outcomes (1)

• Main voluntary squeeze increment

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

  Day 1

Secondary Outcomes (7)

• Anal resting pressure (mmHg)

  Day 1

• Main voluntary squeeze increment

  Day 1

• Endurance squeeze pressure

  Day 1

• Straining pressure

  Day 1

• Total duration of procedure

  Day 1

Study Arms (2)

THD® Anopress (Sensyprobe) first

OTHER

Device: THD® Anopress (Sensyprobe) first

High Resolution Anorectal Manometry first

OTHER

Device: High Resolution Anorectal Manometry first

Interventions

THD® Anopress (Sensyprobe) first DEVICE

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

THD® Anopress (Sensyprobe) first

High Resolution Anorectal Manometry first DEVICE

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

High Resolution Anorectal Manometry first

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with a history of obstetric anal sphincter injury and are:
• a) At least 6 weeks postpartum
• Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.
• Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
• 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.

You may not qualify if:

• Existing anal pain precluding anorectal examination
• Neurological conditions such as stroke, multiple sclerosis, spinal cord injury or Parkinson's disease
• Age \<18 years old
• Currently pregnant -

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Kings College Hospital

London, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: July 24, 2025
• Study Start: March 1, 2025
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)