Interstim Amplitude study
Research type
Research Study
Full title
Interstim Amplitude study
IRAS ID
236497
Contact name
Mahreen Pakzad
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 16 days
Research summary
The indication for this study is overactive bladder (OAB), Symptoms of OAB include an increased urge to urinate that may lead to unconscious leakage of urine. The patients enrolled in this study will receive a Medtronic Interstim System to treat these symptoms. This system is routinely available as part of normal clinical care and is not experimental. \nThe purpose of this prospective, multicenter, randomized, single‐blind feasibility study is to gather information about how the settings of the InterStim system will affect OAB symptoms. The specific setting that is being investigated in this study is called amplitude. Amplitude refers to the intensity level at which the InterStim device is set. This study will investigate the efficacy and quality of life of patients who have OAB under 3 different amplitude settings (sub‐sensory amplitudes of 50% and 80% of sensory threshold and sensory threshold)
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/0150
Date of REC Opinion
20 Feb 2018
REC opinion
Favourable Opinion