Pelvic Floor Exercises for Suboptimal Anorectal Manometry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised pelvic floor muscle exercises.
- Who it may be relevant to
- Registry conditions: Obstetric Anal Sphincter Injury. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)
Overview
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)
Interventions
- Behavioral Supervised pelvic floor muscle exercises
4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)
Primary outcome measures
- Success [Time frame: 4 months]
Secondary outcome measures (4)
- Change or recommended mode of delivery [Time frame: 4 months]
- Change in St Mark's Score [Time frame: 4 months]
- Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) [Time frame: 4 months]
- Change in Faecal Incontinence Quality of life Scale [Time frame: 4 months]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Kings College Hospital — London
Identifiers
NCT: NCT07062731 · IRAS 353671