Benign Prostatic Hyperplasia
Conditions
Keywords
Prostate, BPH, Benign, Minimally Invasive, Temporary
Brief summary
To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).
Detailed description
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
Interventions
DEVICEUrocross implant
Urocross implant inserted via delivery catheter
DIAGNOSTIC_TESTSham-control
Cystoscopy
Sponsors
Prodeon Medical, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).
Intervention model description
Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has signed an informed consent form (ICF). 2. Men ≥ 45 years. 3. Symptomatic BPH with the following (all must be met): * IPSS ≥ 13. * Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL. * PVR \< 250 mL. 4. Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization. 5. Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation. Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.
Exclusion criteria
Subjects who meet ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Urocross Expander Implant | more than 7 days post procedure | The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void. |
| Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath | 3 months post-procedure | The primary efficacy endpoint is Change from Baseline in Total International Prostate Symptom Score (IPSS) at 3 months post-procedure. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms. The study is powered to show that the average improvement in Total IPSS among the Urocross Implant subjects is more than 25% greater than the average improvement in Total IPSS among the sham-control subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in Total IPSS for subjects randomized to the Urocross Implant | 3 months post-procedure | The major secondary efficacy endpoint is the percent change in Total IPSS from baseline (i.e., pre-procedure) to 3 months post-procedure for subjects randomized to the Urocross Implant group. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms. |
Countries
United States
Outcome results
None listed