NCT05884580

Brief Summary

The goal of this clinical study is to assess the effectiveness and safety of the Neuflo System for the treatment of benign prostatic hyperplasia (BPH). The main questions it aims to answer are:

  • Can treatment with the Neuflo System lead to at least a 30% improvement in lower urinary tract symptoms (LUTS) secondary to BPH, as measured by the international prostate symptom score (IPSS) at 3 months after treatment which is sustained for 12 months?
  • Is treatment with the Neuflo System tolerable to the patient, as measured by visual analog score (VAS) for pain before and after treatment and procedural medication requirements?
  • Is treatment with the Neuflo System safe, as measured by the incidence and severity of device or procedural related serious adverse events. Participants will be enrolled in the study over a 6 month period. Each participant will be treated with the Neuflo System and assessed at 3 and 12 months following treatment. A subgroup of patients will have an MRI at 1 week to assess the volume and location of ablated tissue. The duration of the study is expected to be 18 months.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 10, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

May 23, 2023

Last Update Submit

February 2, 2026

Conditions

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms

Keywords

prostatecatheterIPSS

Outcome Measures

Primary Outcomes (1)

  • Effectiveness: Relief of BPH symptoms as measured by International Prostate Symptom Score (IPSS)

    Participants IPSS scores have a possible range of 13 to 35 with higher scores indicating more severe symptoms. Effective relief of BPH symptoms will be indicated by improvement (reduction) at 3 months of at least 30% from baseline IPSS score.

    3 months after treatment

Secondary Outcomes (10)

  • Improvement in urinary function (Qmax)

    At 3 months after treatment

  • Improvement in urinary function (PVR)

    At 3 months after treatment

  • Improvement in sexual function

    At 3 months after treatment

  • Improvement in quality of life

    At 3 months after treatment

  • Treatment tolerability & procedural medication requirements

    On day of treatment only

  • +5 more secondary outcomes

Other Outcomes (1)

  • Safety: safety of the Neuflo System

    Up to 12 months after treatment

Study Arms (1)

Participants receiving treatment with the Neuflo BPH Treatment System.

EXPERIMENTAL
Device: Neuflo BPH Treatment System

Interventions

Neuflo BPH Treatment SystemDEVICE

The Neuflo BPH Treatment System is designed to treat patients with lower urinary tract symptoms (LUTS) associated with BPH. It is an outpatient-based, minimally invasive treatment option and uses hydrolysis to reduce prostatic tissue in the lateral lobes of the prostate. Reduced pressure and constriction of the urethra alleviates urinary and other symptoms of BPH.

Also known as: Neuflo Water Hydrolysis System
Participants receiving treatment with the Neuflo BPH Treatment System.

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males aged 45 years of age or older
  • IPSS score of 13 or higher
  • Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding:
  • voided volume of at least 100 ml, and,
  • Post Void Residual (PVR) of 250 ml or less
  • Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI
  • Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI
  • Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI
  • Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound or MRI
  • Participant must have the ability to understand and consent to participate in this study
  • Participant must be willing and able to participate in follow-up evaluations

You may not qualify if:

  • Outlet obstruction due to an enlarged middle lobe or significant central gland of the prostate
  • Significant transverse asymmetry of prostatic lateral lobes
  • Participant has an implantable pacemaker or cardiac defibrillator
  • Participant has a penile implant
  • History or current diagnosis of prostate cancer or bladder cancer
  • Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI is treated and followed with a negative urine test result)
  • Neurogenic, decompensated, or atonic bladder
  • Overactive bladder in the absence of prostatic obstruction
  • Current, recurrent (two or more) urethral strictures or muscle spasms that prevent insertion of the catheter
  • Bleeding disorders or takes anticoagulation medications unless anti-platelet medication has been discontinued for at least 7 days prior to treatment (Participants are allowed to delay or repeat screening to fulfil this requirement)
  • Previous rectal surgery other than haemorrhoidectomy
  • Previous radical pelvic surgery or pelvic irradiation
  • Interest in maintaining fertility
  • Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH
  • Use of Alpha blocker for the treatment of BPH within 14 days of treatment date. (Participants are allowed to delay or repeat screening to fulfil this requirement)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Bay of Plenty

Tauranga, Tauranga, 3112, New Zealand

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicentre, single-arm clinical evaluation
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 1, 2023

Study Start

November 10, 2023

Primary Completion

January 9, 2026

Study Completion

January 10, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)