Vysera Intraurethral Device Rev 01
Research type
Research Study
Full title
To demonstrate that the patient has the ability to activate the Vysera Intraurethral Device to void the bladder.
IRAS ID
157011
Contact name
Marcus Drake
Contact email
Sponsor organisation
Vysera Biomedical Ltd.
Research summary
The study of the Vysera Incontinence device is being undertaken to demonstrate the performance of a new type of urological valve, which is intended to treat men with Stress Urinary Incontinence (SUI). The device is a soft synthetic valve that can be positioned at the junction between the urethra and the bladder. The objectives of the study are to determine ease of delivery of the valve, patient tolerance of the valve, performance of the valve and removal of the valve. The study is carried out in two stages. The first stage verifies delivery and retrieval of the device and is completed while the patient is attending the clinic for routine cystoscopy. A cystoscopy is an examination where a doctor looks into the bladder with a special telescope called a cystoscope. The doctor using a catheter places the valve in position. The doctor then examines that it is placed correctly. Following examination the doctor removes the device, again using a catheter based retrieval device. The second stage of the study examines on the performance of the valve and the patient’s ability to use it. The valve uses the patient’s ability to strain to activate it therefore needing no external activation mechanism. Again the doctor places the valve in position. The patient is asked to activate the valve in order to empty their bladder on a number of occasions. Following examination the doctor removes the device Before leaving the patient is asked to complete associated questionnaires regarding tolerance and comfort of the device. The study is carried out under the supervision of the doctor at the hospital. Though there are no immediate benefits to the patient, the benefits of the Valve are potentially very significant and could improve the quality of life for patients with Stress Urinary Incontinence.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1064
Date of REC Opinion
16 Sep 2014
REC opinion
Further Information Favourable Opinion