Pelvic Floor Exercises for Suboptimal Anorectal Manometry

NCT07062731 | Recruiting

• 1 other identifier: IRAS 353671
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Obstetric Anal Sphincter Injury

Keywords

pelvic floor muscle exercises

Outcome Measures

Primary Outcomes (1)

• Success

  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 months

Secondary Outcomes (4)

• Change or recommended mode of delivery

  4 months

• Change in St Mark's Score

  4 months

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

  4 months

• Change in Faecal Incontinence Quality of life Scale

  4 months

Study Arms (1)

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

Behavioral: Supervised pelvic floor muscle exercises

Interventions

Supervised pelvic floor muscle exercises BEHAVIORAL

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

Obstetric anal sphincter injury (suboptimal/ abnormal)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Kings College Hospital

London, United Kingdom

RECRUITING

Central Study Contacts

Kar Yee Lor, MBChB

CONTACT

+442032993568; kch-tr.anopress-research@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kar Yee Lor

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 14, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)