The ProVerum First in Man PROVE Study

Study Overview
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Brief Summary
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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).

Official Title
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The ProVerum First in Man PROVE Study

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: The ProVee Urethral Expander System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomised, single centre, safety and feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms | Device: The ProVee Urethral Expander System<br>* The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.<br>* Other names: The ProVee Expander;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deployment of the Implant | Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy | Immediately after the implant deployment procedure | 
| Expansion of the Implant | Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT | Within 24 hours of the implant deployment procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period |  | Immediately after the implant deployment procedure, within 24 hours | 
| Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years |  | 2 years | 
| Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms | Change in symptom score using the Improvement in International Prostate Symptom Score and Quality of Life score instrument within the 2 year follow up period | 2 years | 
| Preliminary assessment of the effectiveness of the procedure in improving urinary flow | Change in Qmax measurement within the 2 year follow up period | 2 years |