RecruitingNCT07062731

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

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


Sponsor

King's College Hospital NHS Trust

Enrollment

50 participants

Start Date

Jun 15, 2025

Study Type

OBSERVATIONAL

Conditions

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 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)


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria12

  • 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.
  • 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 Criteria7

  • 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

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Interventions

BEHAVIORALSupervised pelvic floor muscle exercises

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


Locations(1)

Kings College Hospital

London, United Kingdom

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NCT07062731


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