The ProVerum First in Man PROVE Study

Launched by PROVERUM MEDICAL · May 31, 2019

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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