Infracoccygeal Botox for Dyssynergia

NCT04879524 | Completed Results

• 1 other identifier: 291709
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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 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:

• 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

Conditions

Dyssynergic Defaecation; Evacuation Disorder; Anismus; Defecation Disorder

Keywords

Botulinum toxin type A; Botox

Outcome Measures

Primary Outcomes (3)

• The Rate of Identification of Puborectalis During Ultrasound Scan

  The investigator will record the number of times the puborectalis muscle is successfully identified using ultrasound scan (muscle seen to contract on volition) and pre-injection EMG (change in EMG waveform on volitional contraction) by the radiologist and neurologist, respectively, at the beginning of the injection procedure.

  Visit 3: week 18

• Procedure Duration

  The investigator will record the time (in minutes) taken to for the radiologist to complete the injection procedure

  Visit 3: week 18

• Procedure Limitations

  The investigator will record any procedure or patient related factors which prevented a successful injection, e.g. body habitus or equipment failure.

  Visit 3: week 18

Secondary Outcomes (3)

• Rate of Adverse Events

  From visit 3 to visit 6: week 18 to 42

• Patient's Level Pain and Comfort Assessed at Post-procedure

  Visit 3: week 18

• The Number of Patient Indicating *Yes*, They Would be Willing to Undergo a Repeat Procedure

  Visit 3: week 18

Study Arms (1)

Percutaneous infracoccygeal Botulinum toxin injection to puborectalis

100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units

Procedure: Percutaneous infracoccygeal Botulinum toxin injection to puborectalis

Interventions

Percutaneous infracoccygeal Botulinum toxin injection to puborectalis PROCEDURE

The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.

Percutaneous infracoccygeal Botulinum toxin injection to puborectalis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with dyssynergic defaecation using Rome IV criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

The Royal London Hospital

London, E1 1FR, United Kingdom

Location

Results Point of Contact

• Title: P Chaichanavichkij
• Organization: Queen Mary University of London

p.chaichanavichkij@qmul.ac.uk

020 7882 8752

Study Officials

• Charles H Knowles, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 10, 2021
• Study Start: August 6, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 20, 2022
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)