PROBLEM/ISSUE BEING ADDRESSED:
Benign Prostatic Hyperplasia(BPH) is an extremely common condition in older men where the prostate gland enlarges causing impingement upon the urethra, the tube which eliminates urine from the bladder. Sufferers of BPH present with Lower Urinary Tract Symptoms (LUTS), including decreased urine stream, incomplete voiding and urinary retention, resulting in a constant ‘topping up’ of the never fully empty bladder causing a frequent urge to urinate, making it difficult to carry out routine activities during the day, insomnia at night and resulting in a profound effect on quality of life. The incidence of BPH is staggering; it develops as an age-related phenomenon in nearly all men. Autopsy studies show the histologic prevalence of BPH to be approximately 20% for men in their 40s, reaching 50% for men in their 60s, and 90% for men in their 80s. In Europe some 26 million men, are affected by bothersome LUTS due to BPH resulting in a cost to the EU Healthcare system of €18Bn p.a.
IMPORTANT FOR SOCIETY:
Patients
- ProVee is a tolerable BPH treatment option
- Low risk, effective and simple treatment
- Side-effect free
- Fast acting and a quick recovery
Physicians
- Minimally invasive surgical solution
- It is not associated with serious harms of surgery
- Can be delivered in the office setting with rapid recovery and symptom relief
- Easy to learn with consistent deployment
Healthcare system
- Cost savings
- No capital equipment purchase
- Less costs associated with the management of complications
OVERALL OBJECTIVES:
The overall objective is to develop a minimally invasive medical device that will relief a patient of BPH symptoms through a simple, 5 minute outpatient procedure to implant the ProVee device under local anesthetic. Once implanted, the ProVee addresses urinary problems, is well tolerated and early data suggests has an excellent safety profile.
