Obstetric Anal Sphincter InjuryNCT07062731
Pelvic Floor Exercises for Suboptimal Anorectal Manometry
An observational study of Obstetric Anal Sphincter Injury, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Anal Sphincter Injury
- What is being tested?
- Supervised pelvic floor muscle exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2025to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Women who have delivered at either Kings College Hospital or Princess Royal Hospital, have sustained an obstetric anal sphincter injury and have suboptimal or abnormal incremental squeeze pressures during anorectal manometry at perineal clinic.
Who may be able to join
- Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
- Are at least 6 weeks postpartum
- Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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.
Show all 12Show fewer
- Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
- Are at least 6 weeks postpartum
- Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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
- Women who have sustained an obstetric anal sphincter injury more than a year ago
- Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.
- Existing anal pain precluding anorectal examination
- Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises
- Age <18 years old
- Currently pregnant
- Inability to comply with pelvic floor muscle exercises
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Kings College Hospital
London
Lizzie Bingle, +44203 299 6635, kch-tr.research@nhs.net
About this study
Official title: Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)
Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg.
This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)
- Conditions
- Obstetric Anal Sphincter Injury
- Being tested
- Supervised pelvic floor muscle exercises
- Keywords
- pelvic floor muscle exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised pelvic floor muscle exercisesBehavioural
4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)
| Study group | Role | What they receive |
|---|---|---|
| Obstetric anal sphincter injury (suboptimal/ abnormal) | Women who have sustained an obstetric anal sphincter injury and was found to have suboptimal (20-40mmHg) or abnormal (<20mmHg) incremental squeeze pressure on anorectal manometry Receives: Behavioral: Supervised pelvic floor muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
- Change of incremental squeeze pressure from abnormal (<20mmHg) or suboptimal (20-40mmHg) to normal (>40mmHg)
- Change of incremental squeeze pressure from abnormal (<20mmHg) to suboptimal (20-40mmHg)
Measured: 4 months
Secondary outcomes (4)
Change or recommended mode of delivery
Change of recommended mode of delivery from elective Caesarean section only to spontaneous vaginal delivery or elective Caesarean section
Measured: 4 months
Change in St Mark's Score
Change in St Mark's score before and after intervention
Measured: 4 months
Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
Change in ICIQ-UI SF before and after intervention
Measured: 4 months
Change in Faecal Incontinence Quality of life Scale
Change in Faecal Incontinence Quality of life Scale before and after intervention
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start15 Jun 2025
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kar Yee Lor, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062731
- Sponsor's protocol ID
- IRAS 353671
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 14 Jul 2025
- 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 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)
- ClinicalTrials.gov ID
- NCT07062731
- Acronym / sponsor ID
- IRAS 353671
- Conditions
- Obstetric Anal Sphincter Injury
- Keywords
- pelvic floor muscle exercises
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 14 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, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg.
This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstetric anal sphincter injury (suboptimal/ abnormal) | – | Behavioral: Supervised pelvic floor muscle exercisesWomen who have sustained an obstetric anal sphincter injury and was found to have suboptimal (20-40mmHg) or abnormal (<20mmHg) incremental squeeze pressure on anorectal manometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have delivered at either Kings College Hospital or Princess Royal Hospital, have sustained an obstetric anal sphincter injury and have suboptimal or abnormal incremental squeeze pressures during anorectal manometry at perineal clinic.
Key inclusion criteria (12 listed)
- Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
- 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 (7 listed)
- Women who have sustained an obstetric anal sphincter injury more than a year ago
- Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.
- Existing anal pain precluding anorectal examination
- Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises
- Age <18 years old
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 |
|---|---|---|
| Supervised pelvic floor muscle exercises4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total) | Behavioural | Obstetric anal sphincter injury (suboptimal/ abnormal) |
Primary outcome
Success
Time frame: 4 months
1. Change of incremental squeeze pressure from abnormal (<20mmHg) or suboptimal (20-40mmHg) to normal (>40mmHg) 2. Change of incremental squeeze pressure from abnormal (<20mmHg) to suboptimal (20-40mmHg)
4 secondary outcomes
Change or recommended mode of delivery
Time frame: 4 months
Change in St Mark's Score
Time frame: 4 months
Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: 4 months
Change in Faecal Incontinence Quality of life Scale
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kar Yee Lor, MBChB (+442032993568, kch-tr.anopress-research@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: 4 months). 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 14 Jul 2025.