The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Male 45-80 years of age
Diagnosed with Benign prostatic hyperplasia (BPH)
Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
Intravesical prostatic protrusion (IPP) > 10 mm
Post-void residual volume (PVR) > 200ml
Single group
Minimally invasive percutaneous ablation
DevicePercutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach
Primary Safety Endpoint
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months
The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.
Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
The Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) is a validated, 4 item, patient-reported outcome instrument that assesses ejaculatory function and bother in men, evaluating domains of ejaculation force, volume, frequency, and satisfaction. A higher score on the first 3 domains indicates better ejaculatory function and the final domain indicates higher quality of life.
Mean change from baseline in prostate volume (cc) measured by MRI
Mean change from baseline in prostate volume (cubic centimeters) as measured by magnetic resonance imaging (MRI) at specified follow-up time points. A reduction in prostate volume is desirable.
Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow
Mean change from baseline in peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.
Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan
Mean change from baseline in post-void residual urine volume (PVR, milliliters) as measured by ultrasound or bladder scan at specified follow-up time points.
Procedure Duration
Time of procedure in minutes
Change from baseline in serum PSA (ng/dl) and testosterone (ng/dl)
Mean change from baseline in serum prostate-specific antigen (PSA, nanograms per milliliter) and total testosterone (nanograms per deciliter) as measured by standard laboratory assay at specified follow-up time points.
Cystoscopic assessment of urethral and bladder integrity
Cystoscopic evaluation of urethral and bladder mucosal integrity at specified follow-up time points to assess for procedure-related anatomical changes or adverse findings.
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Vivifi Medical
Lead sponsor
RQM Plus
Collaborator
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