Status:
COMPLETED
Infracoccygeal Botox for Dyssynergia
Lead Sponsor:
Queen Mary University of London
Conditions:
Dyssynergic Defaecation
Evacuation Disorder
Eligibility:
All Genders
18-80 years
Brief Summary
Background: Constipation is a common problem, affecting up to 20% of the population during their lifetime. Some patients respond poorly to standard treatments such as laxatives. A subgroup of these h...
Detailed Description
Patients with dyssynergic defaecation represent a subgroup of a larger group of patients presenting with symptoms of chronic constipation. The disorder is characterised by impaired stool expulsion as ...
Eligibility Criteria
Inclusion
- Adult patients aged between 18 and 80 years
- Diagnosis of dyssynergic defaecation using Rome IV criteria
- Ability to understand written and spoken English
- Ability and willingness to give informed consent
Exclusion
- Paediatric patients (age under 18 years)
- Diagnosis of defined structural or metabolic diseases that could cause constipation, such as Hirschsprung's disease, Parkinson's disease, multiple sclerosis, hypothyroidism (untreated), diabetic neuropathy, muscular dystrophy, motor neurone diseases, spinal injury leading to paraplegia, cauda equina syndrome
- Psychiatric or physical inability to comply with the study protocol (including e-diary assessments) at investigator discretion.
- Contra-indications to BTXA such as allergies, pregnancy (or intention to become pregnant during study period), breastfeeding, generalised disorders of muscle activity, myasthenia gravis
- Contra-indications to infracoccygeal injection at injection site such as infection or pressure sore, spina bifida, pilonidal disease, bleeding disorders (including therapeutic anticoagulation)
- Morbid obesity (BMI ≥ 40)
- Defunctioning loop or end stoma in situ
- External rectal prolapse
Key Trial Info
Start Date :
August 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04879524
Start Date
August 6 2021
End Date
December 20 2022
Last Update
March 21 2025
Active Locations (1)
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1
The Royal London Hospital
London, United Kingdom, E1 1FR