Study identifying and risk stratifying men with or without CVD and ED
Research type
Research Study
Full title
A prospective cohort study identifying cardiovascular risk factors and cardiovascular disease in men with end stage erectile dysfunction undergoing penile prosthesis implantation. Can pre-operative parameters predict cardiovascular events and patient self-reported outcomes following implantation of penile prosthesis?
IRAS ID
236512
Contact name
David J. Ralph
Contact email
Sponsor organisation
University College London Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
It is well described in the literature that erectile dysfunction (ED) is a marker of increased risk of cardiovascular disease (CVD) and therefore the diagnosis of ED should provide an opportunity for cardiovascular risk reduction. This prospective controlled cohort study will evaluate patients with end stage ED, who are being considered for insertion of penile prostheses for end stage ED and risk stratify them in the pre-operative work-up.
The aim of this study is to identify men with Erectile Dysfunction (ED) with concomitant Cardiovascular disease (CVD) or at potential future risk for CVD development. Patients with end-stage ED suitable for surgical management will be recruited into the study. Cardiovascular status and sexual function data will be collected before and after surgery. This will aid us to develop a tool to risk stratify patients before their surgery. The ultimate objective is to make future ED surgery as safe and efficient as possible.
Patients with the following attributes will be excluded from the study:
• Age below 40-years-old
• ED secondary to a neurological disease (e.g. status post pelvic or spinal injury)
• Pure psychogenic ED
• Have already got a penile prosthesis
All other patients waiting for penile implant insertion will be offered to participate in the study. Study has been planned for 2 years – 1 year enrolment and 1 year follow up.
Study will be pursued at UCLH. Although we cannot guarantee any specific treatment benefits, however, patient will be fully investigated, assessed and treated for any undiagnosed cardiac disease. Any form of research does help the society and other patients with similar condition.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0470
Date of REC Opinion
15 Aug 2019
REC opinion
Favourable Opinion