Health TrialsbyHealthPanel

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

ConditionObstetric Anal Sphincter Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Inclusion Criteria

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Supervised pelvic floor muscle exercises

    Behavioral

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Obstetric anal sphincter injury (suboptimal/ abnormal)1 intervention

Trial outcomes

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)

Time frame
4 months

Secondary outcomes

1

Change or recommended mode of delivery

Change of recommended mode of delivery from elective Caesarean section only to spontaneous vaginal delivery or elective Caesarean section

Time frame
4 months
2

Change in St Mark's Score

Change in St Mark's score before and after intervention

Time frame
4 months
3

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

Change in ICIQ-UI SF before and after intervention

Time frame
4 months
4

Change in Faecal Incontinence Quality of life Scale

Change in Faecal Incontinence Quality of life Scale before and after intervention

Time frame
4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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