Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07062731

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obstetric Anal Sphincter Injury

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Inclusion Criteria
  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Supervised pelvic floor muscle exercises

Behavioral

4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)

Primary outcomes

  1. Success

    Time frame: 4 months

    • 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)

Secondary outcomes

  1. Change or recommended mode of delivery

    Time frame: 4 months

    Change of recommended mode of delivery from elective Caesarean section only to spontaneous vaginal delivery or elective Caesarean section

  2. Change in St Mark's Score

    Time frame: 4 months

    Change in St Mark's score before and after intervention

  3. Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF)

    Time frame: 4 months

    Change in ICIQ-UI SF before and after intervention

  4. Change in Faecal Incontinence Quality of life Scale

    Time frame: 4 months

    Change in Faecal Incontinence Quality of life Scale before and after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Kar Yee Lor, MBChB

CONTACT

[email protected]

+442032993568

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.