BPH With Symptomatic Lower Urinary Tract Symptoms
Conditions
Keywords
BPH / LUTS
Brief summary
The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.
Detailed description
This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).
Interventions
DEVICEProVee device
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Sponsors
ProVerum Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males \> 45 years of age 2. IPSS of ≥ 13, IPSS V/S \> 1 at baseline assessment 3. Prostate volume of ≥ 30 cc and ≤ 80 cc 4. Prostatic urethral L2 lengths ≥ 3.75 cm by TRUS 5. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.
Exclusion criteria
1. Void volume \<125 ml; Qmax \> 12 ml/s; PVR \> 250 ml 2. Obstructive median lobe defined by EITHER \>10mm protrusion on sagittal mid-prostate plane as measured by TRUS OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve'' 3. High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction 4. Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible 5. Acute urinary retention 6. Known immunosuppression 7. History of or suspected prostate or bladder cancer 8. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated). 9. Recent urinary tract stones OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure 10. A history of prostatitis within the last two years 11. Active or history of epididymitis within the past 3 months 12. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes 13. History of urinary retention within 12 months of baseline assessment 14. Requiring self-catheterization to void 15. An active urinary tract infection (UTI) at time of index procedure 16. Gross haematuria, within 3 months of index procedure. 17. Subjects with known allergy to nickel or titanium 18. Life expectancy estimated to be less than 60 months 19. Taking androgens, unless eugonadal state for at least 3 months or greater with a stable dosage for at least 2 months as documented by the Investigator 20. Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 months of baseline assessment 21. Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment 22. Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2 weeks of baseline assessment 23. Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment 24. Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baseline assessment unless there is documented evidence that the patient was on the same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued for entrance into or throughout the study) 25. Use of anticholinergics or cholinergic medication within 2 weeks of baseline assessment 26. Use of beta-blockers where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last 6 months) 27. Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks of baseline assessment. 28. Current treatment with anticoagulants (e.g., coumadin or enoxaparin) or antiplatelet medications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patient unable to stop taking anticoagulants and/or antiplatelets within 3 days prior to the procedure or coumadin at least 5 days prior to the procedure. Low dose aspirin ≤100mg/day not prohibited 29. Future fertility concerns 30. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate; including penile implants 31. Previous pelvic irradiation or radical pelvic surgery 32. Previous rectal surgery (other than haemorrhoidectomy) or known history of rectal disease 33. Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology 34. Urethral pathologies that may prevent insertion of Delivery System 35. Uncontrolled diabetes mellitus including Hgb AIC \>8% 36. Overactive bladder (OAB) requiring treatment by OAB medication 37. Urinary incontinence 38. Patients taking tri-cyclic antidepressants. 39. Compromised renal function (i.e., serum creatinine \>1.8 mg/dl or upper tract disease) 40. Hepatic disorder, bleeding disorders or metabolic impairment that might confound the results of the study or have a risk to subject per investigator's opinion 41. Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN, NYHA Class III or IV, cardiac arrhythmias that are not controlled by medication/medical device, myocardial infarction within the past 6 months, COPD with FEV1 \<50, renal illness that might prevent study completion or would confound study results 42. Vulnerable populations such as incarcerated or institutionalized adults, inmates, patients with physical, psychological (such as developmentally delayed adults), or medical impairment that might, in the judgment of the Investigator, prevent study completion or comprehension, or may confound study results (including patient questionnaires) 43. History or current medical condition that would result in an unacceptable patient risk if that subject were to be included in the study 44. Any subject that is currently enrolled in another ongoing investigational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | (time frame: procedure to 3 months) | Rate of device or procedure related serious adverse events through 3-months. |
| Need for urinary catheterization | (time frame: >7 days post procedure to 3-months) | The rate of extended post-operative urinary catheterization (\> 7 days from treatment) for inability to void among patients treated with the ProVee System for BPH. |
| Technical Success | Procedure | The percentage of subjects where the expander is deployed in the location intended by the user. This endpoint will be met if the Observed Technical Success is \>95%. |
Countries
Ireland, United States
Outcome results
None listed