Pelvic floor exercise program for weak anal sphincter after childbirth

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

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 type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: King's College Hospital NHS Trust (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT07062731 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

London

• Kings College Hospital — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Kar Yee Lor, MBChB

Conditions Obstetric Anal Sphincter Injury; pelvic floor muscle exercises