Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment50 (estimated)
SponsorKing's College Hospital NHS Trust
Academic / other
Locations1 site (London)
StatusRecruiting
StartedJune 15, 2025
Main results expectedJune 15, 2027
Study endsSeptember 15, 2027
Registry record updatedJuly 14, 2025
Trial IDNCT07062731 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.