OverActive bladder StImulation System study (OASIS) G02-CLP-0002
Research type
Research Study
Full title
A prospective study to assess the efficacy and safety of the BlueWind RENOVA iStim™ System for the treatment of patients diagnosed with overactive bladder (OASIS – OverActive bladder Stimulation System study)
IRAS ID
276937
Contact name
Philip Toozs-Hobson
Contact email
Sponsor organisation
Bluewind Medical LTD.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CI/2019/0039, MHRA
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Overactive bladder is a common urological chronic condition that significantly impairs the quality of life of those affected, which ranks among the most prevalent and challenging problems in urology.
The BlueWind RENOVA iStim™ System is intended for peripheral nerve stimulation and indicated for the treatment of patients with overactive bladder (OAB) and associating symptoms of urinary urgency, urinary urgency incontinence (UUI) and urgency frequency (UF) alone or in combination. The objective of this study is to demonstrate efficacy and safety of the treatment of OAB with BlueWind RENOVA iStim™ System therapy.
This study is designed as a prospective, interventional, multi-center, single arm, open label study funded by BlueWind Company. Approximately 200 (195-230) subjects are expected to enrolled to the study in approximately 30 European and US sites including Belgium, Nethrelands, Germany, United Kingdom and USA.
The BlueWind RENOVA iStim™ System, is planned to be implanted under local anesthesia and activated to obtain tailored patient therapy. Patients will attend the clinic at 1-, 3-, 6-, 9- and 12-months post system activation.
Based on previous experience with the RENOVA iStim™ System study, results have shown there is potential benefit in therapy of the described indication.REC name
London - Bromley Research Ethics Committee
REC reference
20/LO/0178
Date of REC Opinion
5 May 2020
REC opinion
Further Information Favourable Opinion