Infracoccygeal Botox for Dyssynergia

CompletedOBSERVATIONAL
Enrollment

8

Participants

Timeline

Start Date

August 6, 2021

Primary Completion Date

August 1, 2022

Study Completion Date

December 20, 2022

Conditions
Dyssynergic DefaecationEvacuation DisorderAnismusDefecation Disorder
Interventions
PROCEDURE

Percutaneous infracoccygeal Botulinum toxin injection to puborectalis

"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 The needle is withdrawn, and the procedure is complete."

Trial Locations (1)

E1 1FR

The Royal London Hospital, London

All Listed Sponsors
lead

Queen Mary University of London

OTHER

NCT04879524 - Infracoccygeal Botox for Dyssynergia | Biotech Hunter | Biotech Hunter