Mode
Text Size
Log in / Sign up
N/A N=8

Infracoccygeal Botox for Dyssynergia

Dyssynergic Defaecation · Evacuation Disorder · Anismus · Defecation Disorder

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: The Rate of Identification of Puborectalis During Ultrasound Scan — 8 Participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Percutaneous infracoccygeal Botulinum toxin injection to puborectalis (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Queen Mary University of London
Primary completion
Aug 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
The Rate of Identification of Puborectalis During Ultrasound Scan
8
PRIMARY
Procedure Duration
5
PRIMARY
Procedure Limitations
SECONDARY
Rate of Adverse Events
SECONDARY
Patient's Level Pain and Comfort Assessed at Post-procedure
2
SECONDARY
The Number of Patient Indicating *Yes*, They Would be Willing to Undergo a Repeat Procedure
8

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 have dyssynergic defaecation where the muscles that control bowel movements fail to relax during pushing, preventing evacuation of stools. Currently, the mainstay of treatment requires muscle retraining by a therapist using a technique called biofeedback. Patients in whom biofeedback has failed are left with few options, one of which includes Botox injection into the pelvic floor muscles involved in the defaecation process. However, current method of injection is inaccurate and often requires anaesthesia. The investigators propose a novel technique for Botox delivery which reduces the risks and associated costs. Objectives: 1. The primary objective is to demonstrate technical feasibility of percutaneous infracoccygeal Botox injection as an alternative to transanal puborectalis muscle injection for the treatment of dyssynergic defaecation. 2. The secondary objectives are to assess the safety and acceptability of this technique, and to derive pilot clinical effectiveness data to inform future studies. Methods: The investigators will carry out Botox injection into the puborectalis muscle under ultrasound guidance in the outpatient department. This will be done by percutaneous injection below the coccyx where the puborectalis has been demonstrated to be easily accessible. An electromyography of the puborectalis is obtained before the injection to demonstrate proof of mechanism. The investigators will collect data using a combination of questionnaires, patient baseline data, and anorectal physiology test results before and after the treatment. Outcomes: * Feasibility: procedure duration, rate of identification of puborectalis by ultrasound scan and pre-injection EMG, procedure limitations, and successful injection rate * Safety: rate of adverse events * Acceptability: patient pain and comfort, willingness to undergo repeat procedure * Preliminary data on effectiveness: Cleveland Clinic constipation score, anorectal physiology test results

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04879524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search