WHO ICTRP trial

SaFaRI: Sacral nerve stimulation versus the FENIX TM magnetic sphincter…

ISRCTN16077538 · International Standard Randomised Controlled Trial Number (ISRCTN) · Not Recruiting

Key facts

Trial ID ISRCTN16077538
Public title SaFaRI: Sacral nerve stimulation versus the FENIX TM magnetic sphincter augmentation for adult faecal incontinence: a randomised Investigation
Scientific title Safari: Sacral nerve stimulation versus the FENIX TM magnetic sphincter augmentation for adult faecal incontinence: a prospective, UK multi-site, parallel-group, randomised clinical study investigating the safety and efficacy of the FENIX TM magnetic sphincter augmentation (MSA) compared to sacral…
Primary sponsor University of Leeds (UK)
Registry International Standard Randomised Controlled Trial Number (ISRCTN)
Recruitment status Not Recruiting
Study type Interventional
Phase Not Applicable
Countries United Kingdom;England
Conditions Faecal incontinence (FI) in adults Signs and Symptoms Faecal incontinence
Interventions SNS ? this is a two-stage procedure whereby a temporary percutaneous electrode is used to stimulate the sacral nerves for a period of two weeks, after which the effect on continence is assessed and the electrode removed. If the response is…
Registration date Jun 17, 2014
Target size 350
Secondary IDs HTA 12/35/07
Registry page isrctn.com

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