The Expander-2 Trial: A Randomized Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

Study Overview
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Brief Summary
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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
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Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study

Official Title
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The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Urocross implant
* Diagnostic Test: Sham-control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed an informed consent form (ICF). Men ≥ 45 years. 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. Prostate volume 30-80 cc. Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day. Exclusion Criteria: Subjects who meet ANY of the following exclusion criteria will not participate in the trial: Previous BPH procedure intended to disobstruct the bladder outlet. Obstructive protruding (mobile) middle (median) prostatic lobe. High bladder neck. Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations. Biopsy of the prostate within past 8 weeks. Confirmed or suspected bladder cancer. Confirmed or suspected prostate cancer. Note: Subjects with suspected prostate cancer with a Prostate Specific Antigen (PSA) level > 2.5 ng/mL and ≤ 10 ng/mL with their free PSA < 25% of total PSA, must undergo a biopsy to rule out the diagnosis of prostate cancer. If biopsy is performed, and subject has no cancer, a waiting period of 8 weeks is required prior to randomization (see exclusion criterion 7). History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months. History of neurogenic bladder. Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis). Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention. Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO). Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a negative urine culture), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months). Active infection including acute bacterial prostatitis. Previous pelvic irradiation or radical pelvic surgery.

Ages Eligible for Study
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Minimum Age: 45 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urocross implant group<br>The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant. | Device: Urocross implant<br>* Urocross implant inserted via delivery catheter<br>|
| Sham Comparator: Sham-control group<br>The sham-control in this trial is cystoscopy only. | Diagnostic Test: Sham-control<br>* Cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Urocross Expander Implant | The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void. | more than 7 days post procedure | 
| Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath | Mean improvement in Total IPSS at 3 months vs baseline | 3 month post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in Total IPSS | Percent change in Total IPSS from baseline to 12 months post-retrieval for subjects randomized to the Urocross Implant group | 12 Month post implant retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, BPH, Benign, Minimally Invasive, Temporary