This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.
Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
PDE5 daily use (on demand use is permitted)
Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
Multiple sclerosis
Parkinson's disease
Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction
Parallel
Zenflow Arm: Zenflow Spring System implant procedure
DeviceThe Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.
Medical Therapy Tamsulosin
DrugTamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily
International Prostate Symptom Score (IPSS) Total Score
Mean change in IPSS Total Score from baseline at 3 months. This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better.
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months. This is a 7-question questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months. This separate Quality of Life (QoL) question, scored 0-6, is asking how the patient would feel if they had to live with their current urinary condition for the rest of their life. The QoL score is reported separately and is not included in the 0-35 IPSS total
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations
In the Spring Implant arm, the patient will be asked if they remain implanted with the Spring Implant and if since last visit, if patient initiated any concomitant BPH medication use (for \> 2 weeks). In the Medical Therapy Arm the patient will be asked since last visit, to confirm if they have been consistently taking Tamsulosin at the required dose.
The observed rates of device related AEs or Tamsulosin-related adverse events
The observed rates of device related AEs or Tamsulosin-related adverse events
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