PTNS vs Renew Anal Insert: a randomised blinded pilot study
Research type
Research Study
Full title
Randomised blinded pilot study to compare percutaneous tibial nerve stimulation with the Renew anal plug device for the treatment of faecal incontinence
IRAS ID
215187
Contact name
Carolynne J. Vaizey
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The aim of this study is to directly compare, the Renew device and Percutaneous tibial nerve stimulation (PTNS) in those with passive or mixed faecal incontinence (FI). The Renew insert is a newer CE single use anal device which is indicated for the management of FI and designed to seal and prevent the involuntary passage of stool from the rectum. PTNS is a form of neuromodulation that offers a simple minimally invasive outpatient treatment. Both of these treatments are already available and we currently use these in clinic as a standard care.
Patients will be randomised to receive either PTNS or the Renew device, 25 per group. They will be randomised to either treatment by a third party. This will be performed by a sealed envelope method. Patients will receive either PTNS or the Renew device for a period of three months. PTNS will be applied once a week at the investigators’ institution. The Renew device will be used daily by the patient from home. At the end of the three months' period the patients will exit the study. Further data will be collected. After the study, each patient will be offered further treatment as desired.REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1821
Date of REC Opinion
17 Jan 2017
REC opinion
Further Information Favourable Opinion