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New portable device could simplify testing for Birth-Related anal injuries

NCT ID NCT07083908

Diagnosis Sponsor: King's College Hospital NHS Trust Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared a new portable device (THD Anopress) with the standard high-resolution manometry for measuring anal sphincter pressures in 53 women who had severe perineal tears during childbirth. The goal was to see if the cheaper, faster device gives accurate results. The findings could help doctors advise women on future pregnancies and deliveries more easily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a cheaper, faster, and more portable way to measure anal sphincter function in women after childbirth injuries.
What could go wrong
This is a small, completed study (53 participants) comparing two devices, not testing a treatment. The new device may not match the accuracy of the current gold standard.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

53 people

The number who actually took part.

Started

Mar 2025

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 -

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obstetric anal sphincter injury

Contacts and locations

Locations

  • Kings College Hospital

    London, United Kingdom

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