The ProVerum First in Man PROVE Study

The ProVerum First in Man PROVE Study

A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).

Inclusion Criteria:

• Males ≥ 50 years of age
• Moderate-to-severe symptomatic BPH
• IPSS of > 15
• Peak urinary flow rate (Qmax) of <12 mL/s
• Prostate volume of ≥ 30 and ≤80 cc
• Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

• A prostatic urethral length of less than 4cm
• A prostatic volume <30cc or >80cc
• An obstructing intravesical prostatic median lobe
• Urinary incontinence due to an incompetent external sphincter
• Urethral pathologies that may prevent insertion of delivery system
• A current symptomatic urinary tract infection
• Current significant visible haematuria
• Patients with known allergy to nickel or titanium
• History of significant medical co-morbidity or prior surgery that may confound the results of the Study
• Another medical condition that would pose an unacceptable patient risk
• Known or suspected urological condition that may affected voiding function
• Neurogenic bladder and/or sphincter abnormalities
• Patients with cognitive disabilities unable to understand and give informed consent to the research study