Pelvic floor exercise program for weak anal sphincter after childbirth
Official title: Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)
Run by King's College Hospital NHS Trust · NCT07062731 · Data updated 2026-11-12
This program will try guided pelvic floor exercises to see if they improve anal squeeze strength in women who had an obstetric anal sphincter injury and low anorectal manometry readings.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | King's College Hospital NHS Trust Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | June 15, 2027 |
| Study ends | September 15, 2027 |
| Registry record updated | July 14, 2025 |
| Trial ID | NCT07062731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women at least six weeks postpartum with a prior obstetric anal sphincter injury, suboptimal incremental squeeze pressure on anorectal manometry, who have not received guided pelvic floor physiotherapy and can attend clinic visits and complete questionnaires.
✕Probably not a fit
Patients with large structural external anal sphincter defects (commonly defined as >30 degrees) or those who have already undergone guided pelvic floor physiotherapy are less likely to gain benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational program enrolling women at least six weeks after an obstetric anal sphincter injury who have suboptimal anorectal manometry results. Participants complete baseline questionnaires and manometry, then attend a supervised course of pelvic floor muscle exercises with a women's health physiotherapist. Manometry and symptom questionnaires are repeated after the program to measure changes in incremental squeeze pressure and symptoms. The goal is to determine whether supervised exercises can improve sphincter function and broaden future delivery options.
Why it matters
Potential benefit: If successful, the exercises could improve anal sphincter strength and potentially allow more women to consider vaginal delivery rather than elective Caesarean section.
How similar studies have gone: Pelvic floor muscle training has shown benefit for pelvic floor symptoms in other contexts, but randomized data demonstrating improvement in anorectal manometry after obstetric sphincter injury are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
1. Are at least 6 weeks postpartum
2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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:
* Inclusion Criteria
1. Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
1. Are at least 6 weeks postpartum
2. Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist 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. Women who have sustained an obstetric anal sphincter injury more than a year ago
2. Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.
3. Existing anal pain precluding anorectal examination
4. Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises
5. Age \<18 years old
6. Currently pregnant
7. Inability to comply with pelvic floor muscle exercises
Where it's running
-
Kings College Hospital
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Kar Yee Lor, MBChB
- Email: kch-tr.anopress-research@nhs.net
- Phone: +442032993568
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Group-based follow-up for women after obstetric anal sphincter injury
A group-based follow-up program is being tested to see if it can improve quality of life for women who had a tear at the anal sphincter after childbirth.
-
Physiotherapy and cold‑pack treatment for first-time mothers with perineal tears after vaginal delivery
This will test whether pelvic floor muscle exercises plus cryotherapy started right after birth reduce perineal pain for first-time mothers who had a grade 2 or higher tear or an episiotomy.
-
Evaluating 3D Ultrasound for Anal Sphincter Assessment
This study is testing new 3D ultrasound techniques to see how well they can check the condition of the anal sphincter in pregnant women and new mothers to better understand related injuries and symptoms.
-
Care pathways for women with obstetric anal sphincter injury-related incontinence
This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.