Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.

NCT07797348 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: CLIN-0298
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia (BPH); Obstructive Lower Urinary Tract Symptoms (LUTS); Enlarged Prostate

Keywords

obstructive lower urinary tract symptoms (LUTS), Benign Prostatic Hyperplasia (BPH),; enlarged prostate; BPH; LUTS; urinary tract symptoms; Benign Prostatic Hyperplasia; obstructive lower urinary tract symptoms; minimally invasive; relieve prostatic urethral obstruction; early intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Day 1) to 3 months

• Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).

  Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).

  Baseline through study completion, an average of 1 year (Duration of study)

Secondary Outcomes (4)

• Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months

  Baseline at 1, 6, and 12 months

• Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months

  Baseline 1, 3, 6 and 12 months

• Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations

  Baseline through study completion, an average of 1 year (Study duration)

• The observed rates of device related AEs or Tamsulosin-related adverse events

  Baseline through study completion, an average of 1 year (Duration of study)

Study Arms (2)

Zenflow Arm: Zenflow Spring System Treatment

ACTIVE COMPARATOR

Zenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols.

Device: Zenflow Arm: Zenflow Spring System implant procedure

Tamsulosin Treatment

ACTIVE COMPARATOR

Medical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily. Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs.

Drug: Medical Therapy Tamsulosin

Interventions

Zenflow Arm: Zenflow Spring System implant procedure DEVICE

The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.

Zenflow Arm: Zenflow Spring System Treatment

Medical Therapy Tamsulosin DRUG

Tamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily

Tamsulosin Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with prostates
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
• In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:
• Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
• Not actively taking any medication indicated for BPH, defined as current use of:
• Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
• alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
• PDE5 daily use (on demand use is permitted)
• Ability to provide informed consent and comply with study procedures and follow-up schedule

You may not qualify if:

• Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
• Neurologic conditions affecting bladder function, including but not limited to:
• Multiple sclerosis
• Parkinson's disease
• Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction

Sponsors & Collaborators

• Zenflow, Inc.: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, open-label, parallel-group assignment post-market clinical trial. Option to crossover.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: September 1, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 1, 2026

Record last verified: 2026-08