The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
The purpose of the Zenflow Study (ZEST CAN) is to evaluate the safety, performance and effectiveness of the Zenflow Spring System for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hyperplasia (BPH). It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.
Toronto Western Hospital
Toronto, Ontario, Canada
RECRUITINGGroupe Sante Brunswick
Pointe-Claire, Quebec, Canada
RECRUITINGSuccessful placement of the Zenflow Spring Implant
Number of successful deployments and procedural successes for the Zenflow System to implant the Spring device in the OR, or in an out-patient clinical setting as compared to total treatment attempts.
Time frame: Day of discharge up to 7 days following device placement
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score
At 3 months, achieve at least 30% mean improvement in International Prostate Symptom Score (IPSS) compared to baseline. The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total IPSS score.
Time frame: 3 month
Need for urinary catheterization
Achieve \< 12% rate of extended post-operative urinary catheterization, defined as an occurrence of a subject requiring catheterization within the first 3 days as part of a postoperative management for inability to void, for greater than 7 days.
Time frame: 7 days after the procedure
Incidence of procedure or device related serious adverse events
Achieve \< 12% rate of device or procedure related SAEs through discharge and 30 days follow up.
Time frame: 30 days after the procedure
Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score.
Time frame: Baseline, 3, 6, 12, 24, 36, 48, & 60 months
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Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain.
Time frame: Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months
Assessment of Adverse Events
Rate of adverse events related to the procedure or device.
Time frame: Up to 5 years
Assessment of Clavien-Dindo events
Proportion of subjects with procedure or device related adverse events classified as Clavien-Dindo Grade 3 or higher or any event resulting in persistent disability evidenced through 3 months post treatment.
Time frame: Up to 5 years
Assessment of PSA
Change in PSA from baseline through 12, 24, 36, 48, \& 60 months post treatment.
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score
Time frame: Baseline, 2 weeks, 1, 6, 12, 24, 36, 48, & 60 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Improvement in flow of urine as measured by uroflowmetry machine.
Time frame: Baseline, 2 weeks, 1, 3, 6, 12, 24, 36, 48, & 60 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of increase in dosage or initiation of new medication to treat symptoms of BPH.
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of repeat treatment.
Time frame: 24 to 60 months