Pelvic Floor Exercises for Suboptimal Anorectal Manometry
NCT ID: NCT07062731
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2025-06-15
2027-09-15
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Supervised pelvic floor muscle exercises
4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)
Interventions
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Supervised pelvic floor muscle exercises
4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)
Eligibility Criteria
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Inclusion Criteria
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.
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
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
18 Years
FEMALE
No
Sponsors
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King's College Hospital NHS Trust
OTHER
Responsible Party
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Kar Yee Lor
Dr. Kar Yee Lor
Locations
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Kings College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRAS 353671
Identifier Type: -
Identifier Source: org_study_id
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