Obstetric Anal Sphincter InjuryNCT07083908
A Comparison of THD® Anopress With High Resolution Anorectal Manometry
A study testing THD® Anopress (Sensyprobe) first and High Resolution Anorectal Manometry first in people with Obstetric Anal Sphincter Injury, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anal Sphincter Injury
- What is being tested?
- THD® Anopress (Sensyprobe) first and High Resolution Anorectal Manometry first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2025to 11 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female patients with a history of obstetric anal sphincter injury and are:
- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sphincter Pressures in Women With Obstetric Anal Sphincter Injury: A Comparison of THD® Anopress With High Resolution Anorectal Manometry
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
- Being tested
- THD® Anopress (Sensyprobe) first, High Resolution Anorectal Manometry first
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THD® Anopress (Sensyprobe) firstDevice
Anorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie)
High Resolution Anorectal Manometry firstDevice
Anorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe)
| Study group | Role | What they receive |
|---|---|---|
| THD® Anopress (Sensyprobe) first | Other | Not described Receives: Device: THD® Anopress (Sensyprobe) first |
| High Resolution Anorectal Manometry first | Other | Not described Receives: Device: High Resolution Anorectal Manometry first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main voluntary squeeze increment
Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)
Measured: Day 1
Secondary outcomes (7)
Anal resting pressure (mmHg)
Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on anal resting pressures (mmHg)
Measured: Day 1
Main voluntary squeeze increment
difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)
Measured: 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)
Measured: Day 1
Straining pressure
Agreement/ accuracy of manometric values of THD® Anopress compared with HD-ARM on straining pressure (mmHg)
Measured: Day 1
Total duration of procedure
Time from commencement to end of procedure (minutes and seconds)
Measured: Day 1
Visual Analogue Scale (VAS)
Visual Analogue Scale -10 points (0-10), with 0 being 'no pain' and 10 being 'worst pain imaginable'
Measured: Day 1
Adverse events
Any adverse reactions ie. patient injury, severe discomfort, medical emergencies encountered
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Mar 2025
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anal Sphincter InjuryStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083908
- Sponsor's protocol ID
- 350163
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sphincter Pressures in Women With Obstetric Anal Sphincter Injury: A Comparison of THD® Anopress With High Resolution Anorectal Manometry
- ClinicalTrials.gov ID
- NCT07083908
- Acronym / sponsor ID
- 350163
- Conditions
- Obstetric Anal Sphincter Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THD® Anopress (Sensyprobe) first | Other | Device: THD® Anopress (Sensyprobe) first |
| High Resolution Anorectal Manometry first | Other | Device: High Resolution Anorectal Manometry first |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients with a history of obstetric anal sphincter injury and are:
- 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.
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THD® Anopress (Sensyprobe) firstAnorectal manometry with THD® Anopress (Sensyprobe) first then with High Resolution Anorectal Manometry (Laborie) | Device | THD® Anopress (Sensyprobe) first |
| High Resolution Anorectal Manometry firstAnorectal manometry with High Resolution Anorectal Manometry (Laborie) first followed by THD® Anopress (Sensyprobe) | Device | High Resolution Anorectal Manometry first |
Primary outcome
Main voluntary squeeze increment
Time frame: Day 1
Difference between maximum voluntary squeeze pressure and maximum resting pressure (mmHg)
7 secondary outcomes
Anal resting pressure (mmHg)
Time frame: Day 1
Main voluntary squeeze increment
Time frame: Day 1
Endurance squeeze pressure
Time frame: Day 1
Straining pressure
Time frame: Day 1
Total duration of procedure
Time frame: Day 1
Visual Analogue Scale (VAS)
Time frame: Day 1
Adverse events
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Obstetric Anal Sphincter Injury
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Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
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Active, not recruitingPhase 3
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
Fecal Incontinence
Enrolling by invitationObservational study
Long-term Pelvic Floor and Sexual Health After Obstetric Anal Sphincter Injury in Finland
Obstetric Anal Sphincter Injury, Sexual Dysfunction and the Mode of Deliveries
Recruiting
Improving Postpartum Quality of Life Through Enhanced Perineal Care Training
Postpartum Quality of Life, Peripartal Maternal Trauma
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THD® Anopress (Sensyprobe) first and High Resolution Anorectal Manometry first in people with Obstetric Anal Sphincter Injury, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main voluntary squeeze increment (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.