Benign Prostatic Hyperplasia
Conditions
Keywords
BPH
Brief summary
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Detailed description
The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and/or remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.
Interventions
DEVICEMinimally invasive percutaneous ablation
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach
Sponsors
Vivifi Medical
RQM Plus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male 45-80 years of age 2. Diagnosed with Benign prostatic hyperplasia (BPH) 3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI 4. Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL) 5. Assessment of future paternity plans 6. Signed the study informed consent 7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
Exclusion criteria
1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy. 2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable 3. Intravesical prostatic protrusion (IPP) \> 10 mm 4. Post-void residual volume (PVR) \> 200ml 5. IPSS QoL score ≤ 3 6. Prostate cancer diagnosis, suspicious DRE, or PSA \> 10ng/mL 7. Patients with clinical history of chronic prostatitis. 8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures. 9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury 10. Patients who are unable to undergo the required anesthesia for the procedure 11. Patients on testosterone replacement therapy 12. Patients unable to hold blood thinners, or with coagulation related issues 13. Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride) 14. Diagnosis of Hidradenitis suppurativa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 24 month follow-up | 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 | From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure. | The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) | From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure. | 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 | From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure. | 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 | From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure. | 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 | Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure. | 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. |
Countries
Panama
Contacts
CONTACTDaniel Root, MD
CONTACTSusan Brief, MS
STUDY_CHAIRDaniel Root, MD
Outcome results
None listed