Infracoccygeal Botox for Dyssynergia

• Research type

  Research Study

• Full title

  Percutaneous infracoccygeal Botulinum toxin injection to puborectalis for the treatment of dyssynergic defaecation: a prospective observational study

• IRAS ID

  291709

• Contact name

  Charles Knowles

• Contact email

  c.h.knowles@qmul.ac.uk

• Sponsor organisation

  Queen Mary, University of London

• Clinicaltrials.gov Identifier

  NCT04879524

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Summary of Research

  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 has 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. We 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: We 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 confirm muscle identification. We 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

  Summary of Results

  This pilot study tested a new method of delivering Botox injection by targeting the key affected muscle (called puborectalis) in dyssynergic defaecation (where the muscle fail to relax appropritely during pushing on the toilet, preventing evacuation of stools) using ultrasound scanning in 8 patients. The procedure was done using ultrasound and electrical current monitoring to guide the injection, and it took about 5 to 10 minutes for most patients. The injections were successfully delivered in all cases, though some procedures were slightly tricky due to limited visibility.

  All patients found the treatment acceptable, most said it was comfortable, and none found it embarrassing. A few experienced mild pain. Overall, patients felt positive and were open to having the treatment again if needed. Importantly, there were no reported side effects or safety concerns, and the treatment did not worsen bowel control.

• REC name

  North of Scotland Research Ethics Committee 2

• REC reference

  21/NS/0088

• Date of REC Opinion

  11 Jul 2021

• REC opinion

  Favourable Opinion