Pelvic Floor Exercises for Suboptimal Anorectal Manometry

King's College Hospital NHS Trust

Status: Enrolling

Conditions: Obstetric Anal Sphincter Injury

Treatments: Behavioral: Supervised pelvic floor muscle exercises

Study type: Observational

Funder types: Other

Identifiers

NCT07062731

IRAS 353671

Details and patient eligibility

About

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)

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Obstetric anal sphincter injury (suboptimal/ abnormal)

Description:

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

Treatment:

Behavioral: Supervised pelvic floor muscle exercises